A Clinical Study of TJ004309 With Atezolizumab (TECENTRIQ®) in Patients With Ovarian Cancer and Selected Solid Tumors
- Conditions
- Ovarian CancerHead and Neck CancerNon Small Cell Lung CancerGastrointestinal CancerTriple Negative Breast CancerOvarian Carcinoma
- Interventions
- Registration Number
- NCT05001347
- Lead Sponsor
- I-Mab Biopharma US Limited
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
-
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:
- Histologically or cytologically confirmed metastatic NSCLC
- Histologically or cytologically confirmed recurrent or metastatic HNSCC (oral cavity, oropharynx, hypopharynx, or larynx)
- Histologically or cytologically confirmed metastatic or non-resectable advanced metastatic gastric or gastroesophageal adenocarcinoma
- Histologically or cytologically confirmed unresectable, locally advanced or metastatic TNBC (confirmed HER2-negative, estrogen receptor-negative and progesterone receptor-negative)
- 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
- PD-L1 expression Tumor Proportion Score (TPS) ≥ 1% for NSCLC and Combined Proportion Score (CPS) ≥ 1% for all other tumor types
- A 28-day washout period after the completion of programmed death-1 (PD-1)/PD-L1 therapy
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description TJ004309 and Atezolizumab TJ004309 TJ004309 20 mg/kg Q3W in combination with atezolizumab 1200 mg Q3W
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) in each Tumor Type Up to 120 weeks Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumors (RECIST v1.1) and iRECIST for target lesions assessed by CT or MRI
- Secondary Outcome Measures
Name Time Method Progression-free-survival (PFS) Up to 120 weeks by RECIST v1.1 and iRECIST
Duration of response (DOR) Up to 120 weeks Time from documentation of tumor response to disease progression assessed among patients who had an objective response
Overall survival (OS) Up to 120 weeks Overall survival (OS) will be calculated for each subject as the number of days from the first day of treatment (Cycle 1 Day 1) to the date of death from any cause.
Pharmacokinetic profiles of serum TJ004309 and atezolizumab Up to 120 weeks Based on Anti-Drug Antibody Results
Pharmacokinetic (PK) parameters: Area under the curve (AUC0-T) From pre-dose in Day 1 of Cycle 1 to post-dose in Day 21 of Cycle 1 (each cycle is 21 days) AUC0-T is the area under the plasma concentration versus time curve calculated using the trapezoidal method over the dosing interval after the first infusion
Assessment of PK parameter: Cmax From pre-dose in Day 1 of Cycle 1 to post-dose in Day 21 of Cycle 1 (each cycle is 21 days) Cmax is maximum drug concentration observed
Incidence of treatment emergent adverse events Up to 120 weeks Treatment-emergent adverse event (TEAE) is assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) criteria (version 5.0) Number of subjects with significant changes in vital signs, physical examinations, and clinical laboratory findings
Number of participants with vital sign abnormalities Up to 120 weeks Assessed by number of participants with clinically significant vital sign values
Objective Response Rate (ORR) Up to 120 weeks Number of responders Assessed by Modified Response Evaluation Criteria In Solid Tumors (RECIST v1.1) and iRECIST for target lesions assessed by CT or MRI
Disease control rate (DCR) Up to 120 weeks Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1
Number of participants with laboratory value abnormalities Up to 120 weeks Assessed by number of participants with clinically significant laboratory values.
Number of participants with abnormal physical examination results Up to 120 weeks Assessed by number of participants with clinically significant abnormal physical examination results
Assessment of PK parameter: tmax From pre-dose in Day 1 of Cycle 1 to post-dose in Day 21 of Cycle 1 (each cycle is 21 days) Time to reach Cmax
Trial Locations
- Locations (17)
Innovative Clinical Research Institute
🇺🇸Whittier, California, United States
Illinois Cancer Specialists
🇺🇸Arlington Heights, Illinois, United States
Texas Oncology - The Woodlands, Gynecologic Oncology
🇺🇸The Woodlands, Texas, United States
Duke Cancer Center
🇺🇸Durham, North Carolina, United States
Medical Oncology Hematology Consultants, PA
🇺🇸Newark, Delaware, United States
Arizona Oncology Associates
🇺🇸Tucson, Arizona, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone
🇺🇸New York, New York, United States
Tri County Hematology and Oncology Associates
🇺🇸Massillon, Ohio, United States
Texas Oncology - Arlington North
🇺🇸Arlington, Texas, United States
Texas Oncology - Austin Central
🇺🇸Austin, Texas, United States
Texas Oncology - Bedford
🇺🇸Bedford, Texas, United States
Texas Oncology - Forth Worth Cancer Center
🇺🇸Fort Worth, Texas, United States
Texas Oncology - Longview Cancer Center
🇺🇸Tyler, Texas, United States
Virginia Cancer Specialists
🇺🇸Fairfax, Virginia, United States
Northwest Cancer Specialists
🇺🇸Vancouver, Washington, United States
Women's Cancer Care
🇺🇸Covington, Louisiana, United States
Maryland Oncology Hematology
🇺🇸Rockville, Maryland, United States