NCT05001347

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: I-Mab Biopharma US Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	TJ004309	Antibody to CD73

Timeline

• Start date: 2021-11-02
• Primary completion: 2023-02-08
• Completion: 2023-02-08
• First posted: 2021-08-11
• Last updated: 2025-12-16
• Results posted: 2025-12-16

Locations

15 sites across 1 country: United States

Regulatory

• FDA-regulated drug study