Clinical trial NCT04045496: A First-in-Human, Phase 1 Study of JAB-3312 in Adult Patients With Advanced Solid Tumors
Official title: A Phase 1, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-3312 in Adult Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Non-small Cell Lung Cancer
Colorectal Cancer
Pancreatic Ductal Carcinoma
Esophageal Squamous Cell Carcinoma
Head and Neck Squamous Cell Carcinoma
Breast Cancer
Other Solid Tumors
Keywords: Src homology phosphatase 2 (SHP2)
PTPN11
Kirsten rat sarcoma (KRAS) proto-oncogene, GTPase
epidermal growth factor receptor (EGFR)
Lead sponsor: Jacobio Pharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-08-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, first-in-human, open-label dose-escalation study to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) and assess the DLT of JAB-3312. It is anticipated that approximately 24 subjects will be enrolled in the dose-escalation phase of the study. JAB-3312 will be administered orally once daily (QD) in 21-day treatment cycles.


Eligibility criteria: Inclusion Criteria:

1. Subject must be ≥18 years-of-age at the time of signature of the informed consent form (ICF).
2. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.
3. Subjects with histologically or cytologically confirmed advanced solid tumors which have progressed despite standard therapy or for which no standard therapy exists.
4. Subjects with life expectancy ≥3 months.
5. Patients must have at least one measurable lesion as defined by RECIST v1.1.
6. Patients who have sufficient baseline organ function.

Exclusion Criteria:

1. Severe autoimmune disease (including immune-related adverse events of prior immune-oncology therapy) or autoimmune disorder that requires chronic systemic corticosteroid treatment at immunosuppressive doses (prednisone \>10 mg/day or equivalent).
2. Known malignant central nervous system disease other than neurologically stable, treated brain metastases.
3. History or evidence of interstitial lung disease, radiation pneumonitis which required steroid treatment, or idiopathic pulmonary fibrosis, pleural or pericardial effusion that required intervention such as a drain.
4. 8. History of seropositive status for hepatitis B, hepatitis C and human immunodeficiency virus (HIV).
5. History or evidence of active infections (Grade ≥2).
6. History or evidence of significant inflammatory or vascular eye disorder.
7. History of an allogeneic bone marrow or solid organ transplant.
8. Use of systemic anti-cancer agent (except for anti-androgen therapy for prostate cancer) or investigational drug ≤28 days prior to the first dose of JAB-3312.
9. History of radiation therapy ≤28 days prior to the first dose of JAB-3312, or likely to require radiation therapy at any time until the 30 days after the last dose of JAB-3312.
10. History of transfusion of whole blood, red blood cell or platelet packets ≤2 weeks before the start of treatment.
11. Subjects experiencing unresolved Grade \>1 toxicity before the start of treatment.

Primary outcomes:
measure: Number of participants with dose limiting toxicities
timeFrame: Approximately 2 years
measure: Find Recommended Phase 2 Dose (RP2D) of JAB-3312
timeFrame: Approximately 2 years
Secondary outcomes:
measure: Number of participants with adverse events
timeFrame: Approximately 2 years
measure: Area under the curve
timeFrame: Approximately 2 years
measure: Cmax
timeFrame: Approximately 2 years
measure: Tmax
timeFrame: Approximately 2 years
measure: T1/2
timeFrame: Approximately 2 years
measure: Objective response rate ( ORR )
timeFrame: Approximately 2 years
measure: Duration of response ( DOR )
timeFrame: Approximately 2 years
Other outcomes:
Locations:
city: Denver
country: United States
facility: HealthONE Clinic Services Oncology-Hematology
state: Colorado
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Houston
country: United States
facility: The University of Texas M. D. Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Washington University School of Medicine
state: Washington
Study officials:
affiliation: Jacobio Pharmaceuticals
name: Jacobio Pharmaceuticals
role: STUDY_DIRECTOR
References: