CompletedPhase 2

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

United States25 participantsStarted 2021-11-02

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

What they're measuring

To Assess the Efficacy of TJ004309 Combined With Atezolizumab in a Cohort of Patients With Platinum-resistant IO Naive Ovarian Carcinoma and a Separate Biomarker Enriched Cohort of Subjects With Selected Tumor Types

Timeframe: Up to 66 weeks

Trial details

NCT IDNCT05001347

SponsorI-Mab Biopharma US Limited

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-02-08

Results submitted2025-09-18

View on ClinicalTrials.gov More Ovarian Cancer trials