Efficacy and Safety of TT-00420 (Tinengotinib) Tablets Versus Chemotherapy in Patients With Advanced Intrahepatic Cholangiocarcinoma Harboring FGFR2 Fusions/Rearrangements or Mutations

Sponsor
TransThera Sciences (Nanjing), Inc.
Study ID
NCT07328919
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Advanced Cholangiocarcinoma
  • Intrahepatic Cholangiocarcinoma (Icc)

Eligibility Criteria

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

Interventions

  • TT-00420 (tinengotinib) — DRUG
    Subject will receive TT-00420 (tinengotinib) once daily in 28-day cycles with initial dosage of 10 mg QD per protocol defined schedule.
  • Oxaliplatin, fluorouracil, calcium folinate, irinotecan, capecitabine — DRUG
    Subjects will receive chemotherapy (mFOLFOX regimen, XELIRI regimen, or irinotecan monotherapy). The dosing schedule involves intravenous administration or oral intake every two weeks (except for capecitabine). Treatment continues until the occurrence of confirmed disease progression, intolerable toxicities, withdrawal of informed consent, death, or other reasons specified in the protocol (whichever occurs first). Among these, subjects receiving the mFOLFOX regimen are limited to a maximum of 6 treatment cycles (approximately 12 administrations).

Study Details

This is an open-label, randomized, controlled, multicenter, phase III clinical study designed to evaluate the efficacy and safety of TT-00420 tablets as monotherapy versus chemotherapy in subjects with unresectable advanced or metastatic intrahepatic cholangiocarcinoma harboring FGFR2 gene fusions/rearrangements or mutations, who have experienced recurrence or progression after prior first-line systemic chemotherapy.

Key Dates

Start date
Jan 31, 2026
Status verified
Dec 2025
Primary completion
Dec 31, 2029
Completion
Dec 31, 2030

Study Design

Enrollment
138 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A (TT-00420 monotherapy)
    The starting dose of TT-00420 tablets is 10 mg QD (5 mg per tablet, 2 tablets), administered orally and taken continuously.
  • Active Comparator: Arm B (chemotherapy)
    Chemotherapy includes mFOLFOX regimen, XELIRI regimen or irinotecan monotherapy.

Primary Outcome Measure

PFS by BICR [ Time Frame: From first study drug administration until the date of first documented progression assessed by BICR or date of death from any cause, whichever came first, assessed up to 24 months. ]

Central Contacts

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