Clinical trial NCT05001347: A Clinical Study of TJ004309 With Atezolizumab (TECENTRIQ®) in Patients With Ovarian Cancer and Selected Solid Tumors
Official title: A Phase 2 Clinical Study of TJ004309 in Combination With Atezolizumab (TECENTRIQ®) in Patients With Advanced or Metastatic Ovarian Cancers and Selected Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Head and Neck Cancer
Non Small Cell Lung Cancer
Gastrointestinal Cancer
Triple Negative Breast Cancer
Ovarian Carcinoma
Lead sponsor: I-Mab Biopharma US Limited
Sponsor class: INDUSTRY
First posted: 2021-08-11
Enrollment: 25
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 multicenter, open label, Phase 2 study of TJ004309 in combination with atezolizumab in patients with advanced or metastatic solid tumors.

Detailed description: This is a multicenter, open label, Phase 2 study of TJ004309 in combination with atezolizumab in patients with advanced or metastatic solid tumors. This clinical study includes two cohorts: Cohort 1 will include Immuno-Oncology (IO) treatment naïve ovarian cancer (OC) patients who have progressed on or after platinum therapy; and Cohort 2 will include patients with head and neck squamous cell carcinoma (HNSCC), non-small cell lung cancer (NSCLC), gastrointestinal cancer (GC), triple negative breast cancer (TNBC), or ovarian carcinoma (OC) with PD-L1 expression ≥ 1%. Additional cohorts for selected tumor types might be added later.

Eligibility criteria: Inclusion Criteria:

* Cohort 1: Patients with histologically confirmed epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer subjects with any high-grade serous component, progressed on or after platinum-containing therapy and not eligible for further platinum containing treatment (platinum-resistant, platinum-refractory disease defined by progression of disease on a platinum-containing regimen or recurrence of disease within 180 days of receiving the last dose of platinum-based treatment).
* Cohort 2: Patients with selected tumor types that have relapsed or progressed after 2 lines of therapy or who are ineligible for other standard of care (SOC) therapies:

  1. Histologically or cytologically confirmed metastatic NSCLC
  2. Histologically or cytologically confirmed recurrent or metastatic HNSCC (oral cavity, oropharynx, hypopharynx, or larynx)
  3. Histologically or cytologically confirmed metastatic or non-resectable advanced metastatic gastric or gastroesophageal adenocarcinoma
  4. Histologically or cytologically confirmed unresectable, locally advanced or metastatic TNBC (confirmed HER2-negative, estrogen receptor-negative and progesterone receptor-negative)
  5. Histologically confirmed ovarian cancer of all high-grade epithelial types who are IO treatment naïve and have progressed after 3 months on or after platinum-containing therapy
  6. PD-L1 expression Tumor Proportion Score (TPS) ≥ 1% for NSCLC and Combined Proportion Score (CPS) ≥ 1% for all other tumor types
  7. A 28-day washout period after the completion of programmed death-1 (PD-1)/PD-L1 therapy
  8. Patients should have no more than 5 prior lines of therapies
* Cohort 2 - (Optional for the ovarian cohort) Pre-treatment fresh tumor biopsies and paired treatment fresh tumor biopsies will be collected from at least 5 patients. Biopsy must be excisional, incisional, or core.

Exclusion Criteria:

* Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX 40 \[Tumor necrosis factor receptor superfamily, member 4 (TNFRSF4)\], CD137 \[tumor necrosis factor receptor superfamily member 9 (TNFRSF9)\]) (only applies to ovarian cancer patients in Cohorts 1 and 2)
* Disease progression within 6 months of starting anti-PD-1 and anti-PD-L1 inhibitors
* Known active or chronic Hepatitis B or Hepatitis C, other hepatitides (non-alcohol steatohepatitis, alcohol or drug-related, autoimmune) serology at screening or cirrhosis
* Active autoimmune disease requiring systemic treatment within the past 12 months
* Active interstitial lung disease (ILD) or pneumonitis or a history of ILD
* Brain involvement with cancer, spinal cord compression, carcinomatous meningitis, or new evidence of brain or leptomeningeal disease; unless the lesion(s) have been radiated or resected, are considered fully treated and inactive, are asymptomatic, and no steroids have been administered for CNS disease over the 7 days prior to study treatment
* Angina, myocardial infarction (MI), symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack TIA), arterial embolism, pulmonary embolism, percutaneous transluminal coronary angioplasty (PTCA), or coronary artery bypass grafting (CABG) within 6 months prior to study treatment
* Known human immunodeficiency virus (HIV) unless CD4+ T cell count \> 350 cells/μL with an undetectable viral load

Primary outcomes:
measure: Objective Response Rate (ORR) in each Tumor Type
timeFrame: Up to 120 weeks
Secondary outcomes:
measure: Incidence of treatment emergent adverse events
timeFrame: Up to 120 weeks
measure: Number of participants with laboratory value abnormalities
timeFrame: Up to 120 weeks
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 120 weeks
measure: Number of participants with abnormal physical examination results
timeFrame: Up to 120 weeks
measure: Objective Response Rate (ORR)
timeFrame: Up to 120 weeks
measure: Duration of response (DOR)
timeFrame: Up to 120 weeks
measure: Disease control rate (DCR)
timeFrame: Up to 120 weeks
measure: Progression-free-survival (PFS)
timeFrame: Up to 120 weeks
measure: Overall survival (OS)
timeFrame: Up to 120 weeks
measure: Pharmacokinetic profiles of serum TJ004309 and atezolizumab
timeFrame: Up to 120 weeks
measure: Pharmacokinetic (PK) parameters: Area under the curve (AUC0-T)
timeFrame: From pre-dose in Day 1 of Cycle 1 to post-dose in Day 21 of Cycle 1 (each cycle is 21 days)
measure: Assessment of PK parameter: Cmax
timeFrame: From pre-dose in Day 1 of Cycle 1 to post-dose in Day 21 of Cycle 1 (each cycle is 21 days)
measure: Assessment of PK parameter: tmax
timeFrame: From pre-dose in Day 1 of Cycle 1 to post-dose in Day 21 of Cycle 1 (each cycle is 21 days)
Other outcomes:
Locations:
city: Tucson
country: United States
facility: Arizona Oncology Associates
state: Arizona
city: Whittier
country: United States
facility: Innovative Clinical Research Institute
state: California
city: Newark
country: United States
facility: Medical Oncology Hematology Consultants, PA
state: Delaware
city: Arlington Heights
country: United States
facility: Illinois Cancer Specialists
state: Illinois
city: Covington
country: United States
facility: Women's Cancer Care
state: Louisiana
city: Rockville
country: United States
facility: Maryland Oncology Hematology
state: Maryland
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone
state: New York
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
city: Massillon
country: United States
facility: Tri County Hematology and Oncology Associates
state: Ohio
city: Arlington
country: United States
facility: Texas Oncology - Arlington North
state: Texas
city: Austin
country: United States
facility: Texas Oncology - Austin Central
state: Texas
city: Bedford
country: United States
facility: Texas Oncology - Bedford
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology - Forth Worth Cancer Center
state: Texas
city: The Woodlands
country: United States
facility: Texas Oncology - The Woodlands, Gynecologic Oncology
state: Texas
city: Tyler
country: United States
facility: Texas Oncology - Longview Cancer Center
state: Texas
city: Fairfax
country: United States
facility: Virginia Cancer Specialists
state: Virginia
city: Vancouver
country: United States
facility: Northwest Cancer Specialists
state: Washington
Study officials:
References: