Clinical Trial to Evaluate the Tolerance of TQB3201 Tablets

Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Study ID
NCT07172126
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TQB3201 tablets — DRUG
    TQB3201 is an orally administered targeted protein chimera (PROTAC) drug in which one end of the drug is attached to a ligand that binds to AR and the other end to a ligand of E3 ligase (CRBN) via a linker. This product is effective against anti-androgen drugs (such as abiraterone, enzalutamide, etc.) resistance mutations, including AR amplification, point mutations (L702H, H875Y, T878A mutations, etc.), and can target the degradation of wild-type AR and AR ligand-binding domain mutants, especially L702H mutations, which is a new generation of AR-PROTAC.

Study Details

TQB3201 is an orally administered targeted protein chimera (PROTAC) drug in which one end of the drug is attached to a ligand that binds to Androgen Receptor (AR) and the other end to a ligand of E3 ligase (CRBN) via a linker. The phase I phase of this trial aims to evaluate the safety, tolerability, and pharmacokinetic characteristics of TQB3201 tablets for the treatment of advanced prostate cancer.

Key Dates

First listed
Sep 15, 2025
Start date
Sep 30, 2025
Status verified
Apr 2025
Primary completion
Apr 30, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
291 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TQB3201 tablets
    Each enrolled subject received 28 consecutive days of administration, once daily after meals. (25mg, 50mg, 100mg, 200mg, 400mg, 800mg, 1200mg)

Primary Outcome Measure

Dose Limiting Toxicity (DLT) [ Time Frame: Up to 28days ]

Central Contacts

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