An Phase Ib/II Clinical Trial of TCC1727 Combination Therapy in Advanced Solid Tumors

Sponsor
Beijing Tide Pharmaceutical Co., Ltd
Study ID
NCT07371663
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • TCC1727 tablet 90mg — DRUG
    TCC1727 tablets 90 mg, orally, twice daily (bid), continuous dosing in 21-day cycles until disease progression
  • TCC1727 tablet 120mg — DRUG
    TCC1727 tablets 120 mg, orally, twice daily (bid), continuous dosing in 21-day cycles until disease progression
  • TCC1727 tablet 160mg — DRUG
    TCC1727 tablets 160 mg, orally, twice daily (bid), continuous dosing in 21-day cycles until disease progression
  • benmelstobart Injection — COMBINATION_PRODUCT
    Administer 1200 mg per dose via intravenous infusion on Day 1 of every 3-week cycle until disease progression.

Study Details

This is a Phase Ib/II clinical study. The Phase Ib dose-escalation study aims to evaluate and determine the recommended Phase II dose (RP2D) of TCC1727 in combination with benmelstobart /olaparib /topotecanfor patients with advanced solid tumors. The Phase II expansion study will assess the efficacy and safety of TCC1727 combined with benmelstobart /olaparib/topotecanin selected advanced solid tumor indications. The study pre-specifies three treatment combinations, with Combination 1 (TCC1727 + benmelstobart) being prioritized for initial evaluation. The decision to proceed with Combination 2 and Combination 3will be based on clinical data from Combination 1.

Key Dates

First listed
Jan 28, 2026
Start date
Dec 3, 2025
Status verified
Oct 2025
Primary completion
Sep 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
266 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: TCC1727 + benmelstobart (Dose Level 1)
    TCC1727 tablets 90 mg orally twice daily (bid) in 21-day cycles combined with benmelstobart injection 1200 mg by intravenous infusion in 21-day cycles until disease progression
  • Experimental: TCC1727 + benmelstobart (Dose Level 2)
    TCC1727 tablets 120 mg orally twice daily (bid) in 21-day cycles combined with benmelstobart injection 1200 mg by intravenous infusion in 21-day cycles until disease progression
  • Experimental: TCC1727 + benmelstobart (Dose Level 3)
    TCC1727 tablets 160 mg orally twice daily (bid) in 21-day cycles combined with benmelstobart injection 1200 mg by intravenous infusion in 21-day cycles until disease progression

Primary Outcome Measure

Phase Ib：To determine dose-limiting toxicity (DLT) at each dose level [ Time Frame: 21 Days ]

Central Contacts

Find similar trials

Nationwide
Endometrial cancer trialsMelanoma trialsOncology trialsGynecologic oncology trialsWomen's health trialsSkin cancer trialsDermatology trials

Related Studies