ABSK-011+BSC vs. Placebo+BSC in Previously Treated Advanced HCC With FGF19 Overexpression

This is a randomized, double-blind, multicenter, Phase 2 study to evaluate the efficacy and safety of ABSK-011 plus BSC versus placebo plus BSC in advanced or unresectable hepatocellular carcinoma (HCC) patients with FGF19 overexpression who have received prior systemic therapy. Approximately 141 advanced or unresectable HCC patients with FGF19 overexpression who have received prior systemic therapy will be enrolled and randomized to experimental arm or control arm in a 2:1 ratio. Patients will receive assigned study treatment, every 28-day treatment cycle within 1 day of randomization until d

Trial Details

NCT ID
NCT07327034
Phase
PHASE2
Sponsor
Abbisko Therapeutics Co, Ltd
Status
RECRUITING
Cancer Type
Liver Cancer
Interventions
  • ABSK-011+BSC
  • Placebo+BSC
Locations (sample)
  • Hefei, Anhui, China|31.86389,117.28083
  • Hefei, Anhui, China|31.86389,117.28083
  • Beijing, Beijing Municipality, China|39.9075,116.39723
  • Chongqing, Chongqing Municipality, China|29.56026,106.55771
  • Fuzhou, Fujian, China|26.06139,119.30611

Key Eligibility Criteria

  • Patients should understand, sign, and date the written voluntary informed consent form prior to any protocol-specific procedures performed. Patient…
  • Patients (male or female) ≥ 18 years of age at the time of signing the informed consent form.
  • Patients with advanced or unresectable HCC confirmed histologically/cytologically or clinically according to the American Association for the Study…
  • Have received at least one prior PD- (L) 1 inhibitor approved as a single agent or in combination for the treatment of HCC and at least one mTKI ap…

For full eligibility, visit ClinicalTrials.gov.

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