Clinical Trial Evaluating TQB6411 Injection in Subjects With Esophageal Cancer

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT07367516
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • TQB6411 Injection — DRUG
    TQB6411 Injection is an antibody-drug conjugate (ADC) targeting Epidermal Growth Factor Receptor (EGFR)/c-Met.

Study Details

The Phase Ib stage of this study primarily aims to evaluate the tolerance and safety of TQB6411 Injection in subjects with recurrent or metastatic Esophageal cancer who have previously failed treatment with PD-1/PD-L1 monoclonal antibodies combined with platinum-based chemotherapy. The Phase II stage primarily aims to evaluate the efficacy of TQB6411 Injection in this same patient population.

Key Dates

Start date
Feb 12, 2026
Status verified
Dec 2025
Primary completion
Sep 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
105 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TQB6411 Injection
    TQB6411 Injection , 21 days as a treatment cycle.

Primary Outcome Measure

Recommended Phase 2 Dose (RP2D) [ Time Frame: 3 mouths ]

Central Contacts

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