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

Who is this study for? Patients with advanced or metastatic ovarian cancers and selected solid tumors
What treatments are being studied? TJ004309+Atezolizumab
Status: Completed
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Arizona
Arizona Oncology Associates
Tucson
California
Innovative Clinical Research Institute
Whittier
Delaware
Medical Oncology Hematology Consultants, PA
Newark
Illinois
Illinois Cancer Specialists
Arlington Heights
Louisiana
Women's Cancer Care
Covington
Maryland
Maryland Oncology Hematology
Rockville
North Carolina
Duke Cancer Center
Durham
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
New York
Ohio
Tri County Hematology and Oncology Associates
Massillon
Texas
Texas Oncology - Arlington North
Arlington
Texas Oncology - Austin Central
Austin
Texas Oncology - Bedford
Bedford
Texas Oncology - Forth Worth Cancer Center
Fort Worth
Texas Oncology - The Woodlands, Gynecologic Oncology
The Woodlands
Texas Oncology - Longview Cancer Center
Tyler
Virginia
Virginia Cancer Specialists
Fairfax
Washington
Northwest Cancer Specialists
Vancouver
Time Frame
Start Date: 2021-11-02
Completion Date: 2023-02-08
Participants
Target number of participants: 25
Treatments
Experimental: TJ004309 and Atezolizumab
TJ004309 20 mg/kg Q3W in combination with atezolizumab 1200 mg Q3W
Related Therapeutic Areas
Sponsors
Leads: I-Mab Biopharma US Limited

This content was sourced from clinicaltrials.gov