Clinical trial NCT04713891: A Study of KF-0210 in Advanced Solid Tumors Patients
Official title: A Phase I, Multi-Center, Open-Label Study to Evaluate the Safety and Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of KF-0210 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Solid Tumor
Colorectal Cancer
Lung Cancer
Squamous Cell Carcinoma of the Esophagus
Gastric Cancer
Bladder Cancer
Lead sponsor: Keythera (Suzhou) Pharmaceuticals Co. Ltd
Sponsor class: INDUSTRY
First posted: 2021-01-19
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this Phase I, Multi-Center, Open-Label Study is to evaluate the safety, tolerability, Pharmacokinetics, Pharmacodynamics and anti-tumor activity of KF-0210 in participants with advanced solid tumors. The study will be conducted in two parts: phase Ia, and phase Ib.

Detailed description: Phase 1a:

The primary objective of the phase 1a part of the study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamic and anti-tumor activity of oral KF-0210 as a single agent in participants with advanced solid tumors, to identify the dose-limiting toxicity and establish the maximum tolerated dose, or maximum administered dose and/or the recommended Phase II dose of KF-0210 in participants with advanced solid tumors.

Phase 1b:

The primary objective of the phase 1b part of the study is to assess the safety, pharmacokinetics, pharmacodynamic and anti-tumor activity of KF-0210 in combination with Atezolizumab in patients with colorectal cancer (CRC) (MSS), lung cancer (LC), squamous cell carcinoma of the esophagus (SCCE), gastric cancer (GC), and bladder cancer (BC).

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years old, male and female;
2. Patients are confirmed by available pathology records or current biopsy having advanced, nonresectable, or recurrent and progressing solid tumors since last anti-tumor therapy, and who are unavailable or intolerable for available standard therapy or there is no standard available therapy.

   * Phase Ia (Dose Escalation): Advanced solid tumors;
   * Phase Ib (Expansion Study): Patients must have any of the following tumor type and have not participated in Phase Ia trial of this study: CRC (MSS), LC, SCCE, GC, and BC. Among them, patients with LC, SCCE, or GC must have undergone PD-1/PD-L1 treatment for at least 12 weeks and failed.
3. Must have at least 1 measurable lesion, according RECIST V1.1 criteria (CT-scans or MRI no longer than 4 weeks before signing ICF);
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
5. Life expectancy≥ 3 months;
6. Females must not be lactating or pregnant at screening or baseline (negative pregnant test).

Exclusion Criteria:

1. Patients with prior anti-tumor therapy within 4 weeks prior to first dosing of KF-0210, including chemotherapy, biotherapy, endocrine therapy and immunotherapy (tumor vaccine, cytokine, or growth factor given to control the cancer);
2. Patients with prior definitive radiation therapy within 6 weeks prior to first dosing of KF-0210, and the irradiated lesions showed no signs of progression if it to be considered target lesions. Or patients with prior palliative radiotherapy within 2 weeks prior to first dosing of KF-0210. Or the radiotherapy-related side effects have unresolved before the study entry. Or use of radiopharmaceuticals (strontium, samarium) within 8 weeks prior to first dosing of KF-0210;
3. Patients who have another active malignancy which is likely to require treatment;
4. Patients who have known active central nervous system (CNS) metastases and/or carcinomatous meningitis;
5. Significant cardiovascular impairment: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, uncontrolled arterial hypertension, unstable angina, myocardial infarction, or stroke within 6 months prior to the first dose of KF-0210; or cardiac arrhythmia requiring medical treatment (including oral anticoagulation);
6. Patients with any active autoimmune disease or a documented history of autoimmune disease, poorly controlled asthma or history of syndrome that required systemic steroids or immunosuppressive medications, except for patients with vitiligo or resolved childhood asthma/atopy. Patients with asthma who require intermittent use of bronchodilators (such as albuterol) will not be excluded from this study;
7. Patients with inflammatory bowel disease or digestive tract diseases (e.g. peptic ulcer disease, including stomach and duodenal ulcer, gastritis and enteritis);
8. Inability to take oral medication, or malabsorption syndrome or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of KF-0210;
9. Concurrent medical condition requiring the use of immunosuppressive medications, or immunosuppressive doses of systemic or absorbable topical corticosteroids except inhaled or intranasal corticosteroids (with minimal systemic absorption);
10. Current use of NSAIDs, COX-1/COX-2 inhibitors within 4 weeks;
11. Patients who have received surgical or interventional treatment (excluding tumor biopsy, puncture, etc.) within 28 days prior to first dosing of KF-0210;
12. Use of other investigational drugs within 28 days or at least 5 half-lives (whichever is shorter) prior to the first dosing of KF-0210;
13. Use of any live vaccines (e.g., intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines) within 28 days prior to the first dosing of KF-0210;
14. Any unresolved toxicities from prior therapy, greater than Common Terminology Criteria for Adverse Events (CTCAE 5.0) grade 1 at the time of starting study treatment with exception of alopecia;
15. Any uncontrolled or severe illness, including but not limited to: ongoing or active infection requiring parenteral antibiotics;
16. Positive screening tests for any one of them: human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg); hepatitis B core antibody (HBcAb) (negative for HBsAg, but HBcAb positive, an HBV-DNA test will be performed and if positive will be excluded), hepatitis C antibody (anti-HCV positive, but negative HCV RNA test is allowed to be included).

Primary outcomes:
measure: Percentage of patient with adverse events / serious adverse events (AEs/SAEs) [Safety and Tolerability]
timeFrame: From consent through 28 days (±7 days) after the last dose or before starting other anti-tumor treatment (whichever occurs earlier)(up to approximately 1 year))
measure: Dose limiting toxicity (DLT) of KF-0210 [Tolerability]
timeFrame: From Cycle 1 Day 1 to Cycle 1 Day 21, each cycle is 21 days.
measure: Maximum tolerated dose (MTD) of KF-0210 alone [Tolerability]
timeFrame: Up to 21 days after first administration in cycle 1, each cycle is 21 days
measure: Change of Body Weight from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 1 of each cycle (each cycle is 21 days), and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Body Temperature from Baseline [Safety]
timeFrame: From screening to the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Pulse rate from Baseline [Safety]
timeFrame: From screening to the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Systolic pressure from Baseline [Safety]
timeFrame: From screening to the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Diastolic pressure from Baseline [Safety]
timeFrame: From screening to the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Heart rate from Baseline [Safety]
timeFrame: From screening to the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of R-R interval from Baseline [Safety]
timeFrame: From screening to the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of P-R interval from Baseline [Safety]
timeFrame: From screening to the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of QRS complex from Baseline [Safety]
timeFrame: From screening to the end of treatment/withdrawal (up to approximately 1 year)
measure: Chang of QT interval from Baseline [Safety]
timeFrame: From screening to the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of corrected QT (QTc) interval from Baseline [Safety]
timeFrame: From screening to the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Fridericia's Correction QT (QTcF) interval from Baseline [Safety]
timeFrame: From screening to the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Eastern Cooperative Oncology Group-Performance Status (ECOG PS) from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 1 of each cycle (each cycle is 21 days), and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Total Protein (TP) from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Albumin (ALB) from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Alanine aminotransferase (ALT) from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Aspartate aminotransferase (AST) from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Alkaline phosphatase (ALP/AKP) from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Total bilirubin from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Direct bilirubin from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Indirect bilirubin from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Glutamyl transpeptidase from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Blood glucose from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Urea from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Uric acid from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Creatinine from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Creatinine Kinase from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Total Cholesterol from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Triglycerides from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Potassium, Sodium, Chloride or Calcium from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Leukocyte Count from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Neutrophil Count from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Percentage of Neutrophil from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Lymphocyte Count from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Percentage of Lymphocyte from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Monocytes Count from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Percentage of Monocytes from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Eosinophils Count from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Percentage of Eosinophils from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Basophil Count from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Percentage of Basophil from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Erythrocyte Count from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Hemoglobin from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Hematocrit Platelets from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Coagulation test-Activated partial thromboplastin time (APTT) from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Coagulation test-Prothrombin time (PT) from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Coagulation test-Fibrinogen(FIB) from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Coagulation test-Thrombin time (TT) from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Urine pH from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change of Specific gravity of urine from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change in Occult blood result from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change in Urine Bilirubin result from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change in Urine protein from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change in Urine Glucose from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change in Ketones from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change in Urobilinogen from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change in Urinary leukocyte from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change in Urine erythrocytes from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Change in Urine Nitrites from Baseline [Safety]
timeFrame: On date of screening (within 7 days before the first dose), Day 8, Day15, Day 21 of cycle 1 (each cycle is 21 days), Day 1 of each cycle from the cycle 2, and at the end of treatment/withdrawal (up to approximately 1 year)
measure: Clinically significant abnormality in physical examinations
timeFrame: On date of screening (within 7 days before the first dose), Day 1 of each cycle (each cycle is 21 days), and at the end of treatment/withdrawal (up to approximately 1 year)
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 5, each cycle is 21 days.
measure: Time of maximum plasma concentration (Tmax)
timeFrame: Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
measure: Area under the plasma concentration-time curve from time-zero extrapolated to infinite time (AUC0-inf)
timeFrame: Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
measure: Area under the plasma concentration-time curve from time-zero to the time of the last measurable concentration (AUC0-t) of KF-0210
timeFrame: Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
measure: Terminal half-life (T1/2) of KF-0210
timeFrame: Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
measure: Accumulation ratio (Rac)
timeFrame: Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
measure: Cmin to Cmax fluctuation between dose time and Tau (DF)
timeFrame: Phase I a: specific time points from Cycle 1 Day 1 to Cycle 1 Day 8; Phase 1b: specific time points from Cycle 1 Day 1 to Cycle 4 Day 15. Each cycle is 21 days.
measure: Blood cytokines/chemokines levels
timeFrame: Up to 21 days after first administration in cycle 1, each cycle is 21 days.
measure: Urine prostaglandin metabolites level
timeFrame: Up to 21 days after first administration in cycle 1, each cycle is 21 days.
measure: Tumor T cell infiltration
timeFrame: Up to 21 days after first administration in cycle 1, each cycle is 21 days.
measure: Change in tumor size from baseline
timeFrame: From screening through the last dose of treatment, each cycle is 21 days.
measure: Objective response rate (ORR)
timeFrame: From screening through the last dose of treatment, each cycle is 21 days.
measure: Duration of response (DOR) (days)
timeFrame: From screening through the last dose of treatment, each cycle is 21 days.
measure: Disease control rate (DCR)
timeFrame: From screening through the last dose of treatment, each cycle is 21 days.
measure: Progression free survival (PFS)
timeFrame: From screening through the last dose of treatment, each cycle is 21 days.
Other outcomes:
Locations:
city: Randwick
country: Australia
facility: Scientia Clinical Research Limited
state: New South Wales
Study officials:
affiliation: Scientia Clinical Research Ltd
name: Rasha Cosman, MD
role: PRINCIPAL_INVESTIGATOR
References: