To Evaluate Efficacy and Safety of TT-00420 (Tinengotinib) as Monotherapy and Combination Therapy in Patients With Advanced Solid Tumors

Sponsor
TransThera Sciences (Nanjing), Inc.
Study ID
NCT05253053
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • TT-00420 — DRUG
    TT-00420 tablet will be administered orally once daily per protocol defined schedule.
  • Combination Product: Atezolizumab — DRUG
    Atezolizumab would be administered via infusion on Day 1 of 21-day cycle
  • Combination Product: Nab-Paclitaxel — DRUG
    Nab-Paclitaxel would be administered via infusion on Day 1 and 8 of 21-day cycle

Study Details

This is a Phase Ib/II, multicenter, open-label study to evaluate the safety and preliminary efficacy of TT-00420 tablet, as monotherapy or in combination regimens, in patients with advanced solid tumors (solid tumor, BTC and TNBC).

Key Dates

Start date
Apr 13, 2022
Status verified
Jun 2025
Primary completion
Aug 31, 2024
Completion
Aug 31, 2024

Study Design

Enrollment
84 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: TT-00420 Tablet Monotherapy
    TT-00420 tablets will be administered once daily in 21-day cycles. Dose escalation will be guided by a 3+3 design in Phase Ib to determine the recommended phase 2 dose (RP2D).
  • Experimental: Arm B: TT-00420 tablet in combination with Atezolizumab Injection (Tecentriq ®)
    TT-00420 tablets will be administered once daily in 21-day cycles. Atezolizumab(1200 mg/20 mL) will be administered intravenously on Day 1 of each 21-day cycle. Dose escalation will be guided by a 3+3 design in Phase Ib to determine the recommended phase 2 dose (RP2D).
  • Experimental: Arm C: TT-00420 tablet in combination with nab-paclitaxel (Abraxane®)
    TT-00420 tablets will be administered once daily in 21-day cycles. Nab-paclitaxel 125 mg/m\^2 will be administered intravenously on Day 1 and 8 of each 21-day cycle. Dose escalation will be guided by a 3+3 design in Phase Ib to determine the recommended phase 2 dose (RP2D).

Primary Outcome Measure

Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment [ Time Frame: Up to 30 days from the last dose ]

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