A Clinical Study of TJ004309 With Atezolizumab (TECENTRIQ®) in Patients With Ovarian Cancer and Selected Solid Tumors

Ovarian Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05001347
• Other study ID #: TJ004309STM103
• Status: Completed
• Phase: Phase 2
• Start date: November 2, 2021
• Est. completion date: February 8, 2023

Study information

• Verified date: October 2023
• Source: I-Mab Biopharma Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a multicenter, open label, Phase 2 study of TJ004309 in combination with atezolizumab in patients with advanced or metastatic solid tumors.

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 information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 8, 2023
• Est. primary completion date: February 8, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Gastrointestinal Cancer
• Gastrointestinal Neoplasms
• Head and Neck Cancer
• Non Small Cell Lung Cancer
• Ovarian Cancer
• Ovarian Carcinoma
• Ovarian Neoplasms
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Drug:
• TJ004309
Antibody to CD73

Locations

Country	Name	City	State
United States	Texas Oncology - Arlington North	Arlington	Texas
United States	Illinois Cancer Specialists	Arlington Heights	Illinois
United States	Texas Oncology - Austin Central	Austin	Texas
United States	Texas Oncology - Bedford	Bedford	Texas
United States	Women's Cancer Care	Covington	Louisiana
United States	Duke Cancer Center	Durham	North Carolina
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	Texas Oncology - Forth Worth Cancer Center	Fort Worth	Texas
United States	Tri County Hematology and Oncology Associates	Massillon	Ohio
United States	Laura and Isaac Perlmutter Cancer Center at NYU Langone	New York	New York
United States	Medical Oncology Hematology Consultants, PA	Newark	Delaware
United States	Maryland Oncology Hematology	Rockville	Maryland
United States	Texas Oncology - The Woodlands, Gynecologic Oncology	The Woodlands	Texas
United States	Arizona Oncology Associates	Tucson	Arizona
United States	Texas Oncology - Longview Cancer Center	Tyler	Texas
United States	Northwest Cancer Specialists	Vancouver	Washington
United States	Innovative Clinical Research Institute	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
I-Mab Biopharma US Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Response Rate (ORR) in each Tumor Type	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	Up to 120 weeks
Secondary	Incidence of treatment emergent adverse events	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	Up to 120 weeks
Secondary	Number of participants with laboratory value abnormalities	Assessed by number of participants with clinically significant laboratory values.	Up to 120 weeks
Secondary	Number of participants with vital sign abnormalities	Assessed by number of participants with clinically significant vital sign values	Up to 120 weeks
Secondary	Number of participants with abnormal physical examination results	Assessed by number of participants with clinically significant abnormal physical examination results	Up to 120 weeks
Secondary	Objective Response Rate (ORR)	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	Up to 120 weeks
Secondary	Duration of response (DOR)	Time from documentation of tumor response to disease progression assessed among patients who had an objective response	Up to 120 weeks
Secondary	Disease control rate (DCR)	Complete response + Partial response + Stable disease (CR+PR+SD) based on RECIST 1.1	Up to 120 weeks
Secondary	Progression-free-survival (PFS)	by RECIST v1.1 and iRECIST	Up to 120 weeks
Secondary	Overall survival (OS)	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.	Up to 120 weeks
Secondary	Pharmacokinetic profiles of serum TJ004309 and atezolizumab	Based on Anti-Drug Antibody Results	Up to 120 weeks
Secondary	Pharmacokinetic (PK) parameters: Area under the curve (AUC0-T)	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	From pre-dose in Day 1 of Cycle 1 to post-dose in Day 21 of Cycle 1 (each cycle is 21 days)
Secondary	Assessment of PK parameter: Cmax	Cmax is maximum drug concentration observed	From pre-dose in Day 1 of Cycle 1 to post-dose in Day 21 of Cycle 1 (each cycle is 21 days)
Secondary	Assessment of PK parameter: tmax	Time to reach Cmax	From pre-dose in Day 1 of Cycle 1 to post-dose in Day 21 of Cycle 1 (each cycle is 21 days)