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 disease progression, intolerable toxicity, start of new anti-tumor therapy, death, patient refuse to continue treatment, loss to follow-up, or other reasons leading to treatment discontinuation. Immediate BICR review is required for patients with radiographic disease progression as assessed by the investigator. If disease progression is assessed by BICR, the investigator is allowed to unblind after disease progression according to the protocol-specified procedures. After unblinding, patients in the experimental arm, study drug should be discontinued. Patients in the control arm may be transferred to receive ABSK-011 plus BSC after assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
141
ABSK-011 capsules will be provided and should be taken twice daily, with an interval of approximately 12 hours. The investigational product should be taken with food, with approximately 150 mL of water.
Placebo capsules will be provided and should be taken twice daily, with an interval of approximately 12 hours. The investigational product should be taken with food, with approximately 150 mL of water.
Anhui Provincial Cancer Hospital
Hefei, Anhui, China
RECRUITINGThe First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
RECRUITINGThe First Affiliated Hospital of USTC
Hefei, Anhui, China
RECRUITINGThe Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
ORR by BICR
Objective response rate (ORR) assessed by Blinded Independent Central Review (BICR) per RECIST v1.1, defined as the proportion of patients achieving complete response (CR) or partial response (PR). Patients who receive crossover treatment or start a new anti-tumor therapy prior to achieve an objective response (PR or CR) will be considered as non-responders.
Time frame: through study completion, up to 2 years
PFS
Defined as the time (months) from randomization to disease progression or death due to any cause, whichever occurs first.
Time frame: through study completion, , up to 2 years
DOR
Defined as the time (months) from the first documented objective response to disease progression or death due to any cause, whichever occurs first.
Time frame: through study completion, up to 2 years
DCR
Defined as the proportion of patients achieving CR, PR, or SD (meeting the minimum criteria for SD lasting at least 6 weeks).
Time frame: through study completion, up to 2 years
TTP
Defined as the time (months) from randomization to disease progression.
Time frame: through study completion, up to 2 years
TTR
Defined as time (months) from randomization to first objective response.
Time frame: through study completion, up to 2 years
OS
Defined as the time (months) from randomization to death due to any cause.
Time frame: through study completion, up to 2 years
ORR by investigator
Objective response rate (ORR) assessed by the investigator per RECIST v1.1, defined as the proportion of patients achieving complete response (CR) or partial response (PR).
Time frame: through study completion, up to 2 years
Adverse events
Incidence and severity of adverse events (AEs), serious adverse events (SAEs), and incidence of adverse events leading to dose interruption, dose reduction, and discontinuation of study treatment. Eastern Cooperative Oncology Group (ECOG) performance status (PS), laboratory tests, electrocardiogram (ECG), vital signs, and physical examination and changes from baseline.
Time frame: through study completion, up to 2 years
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Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
RECRUITINGPeking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGChongqing university cancer hospital
Chongqing, Chongqing Municipality, China
RECRUITINGThe First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
RECRUITINGFujian Cancer Hospital
Fuzhou, Fujian, China
RECRUITINGSun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITING...and 41 more locations