A Phase 2, Open-Label Study of ABSK-011 Combined Atezolizumab or SOC in HCC Patients (NCT05441475) | Clinical Trial Compass
By InvitationPhase 2
A Phase 2, Open-Label Study of ABSK-011 Combined Atezolizumab or SOC in HCC Patients
China118 participantsStarted 2021-12-30
Plain-language summary
This study is an open phase II clinical study, which consists of part a and Part B. Part a will evaluate the safety and tolerability of absk-011 combined with atilizumab in patients with advanced or unresectable HCC to And pk/pd characteristics, and determine the treatment plan of Part B. Part B will evaluate absk-011 combined with atilizumab Anti FGF19 overexpression in advanced stage or non resectable patients who have not received systemic therapy or only received first-line systemic therapy before In addition to the safety and tolerability of HCC subjects, the antitumor activity of the combination will be further evaluated.
Part C comprises two parts: Part C1 and Part C2. A maximum of 54 subjects with advanced or unresectable hepatocellular carcinoma (HCC) with FGF19 overexpression and no prior systemic therapy will be planned for enrollment. Eligible subjects will be prioritized for assignment to Part C2 to receive study treatment. Treatment will continue until the earliest occurrence of intolerable toxicity, disease progression, initiation of new anti-tumor therapy, withdrawal of informed consent, loss to follow-up, death, or study termination.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. before implementing any program related procedures, the subjects should understand and voluntarily sign the written informed consent and indicate the date. Subjects should be able and willing to follow the study follow-up and study procedures in the protocol.
✓. there is no limit on gender, and the age when signing the informed consent is ≥ 18 years old.
✓. part a: subjects with advanced or unresectable HCC who must be confirmed by histology, cytology or imaging, are not suitable for curative surgery and / or local treatment, have disease progression or cannot tolerate standard treatment after standard treatment, and have no standard treatment due to physical conditions or disease status (according to local / regional guidelines), and the child Pugh score is 5-6.
✓. Provide archived tumor tissue samples or undergo biopsy for FGF19 overexpression testing at the central laboratory.
✓. BCLC stage B or C, Child-Pugh score 5-6, no hepatic encephalopathy, and no ascites requiring medical intervention within 7 days prior to the first dose.
✓. At least 1 measurable target lesion per RECIST 1.1. For subjects who received prior locoregional therapy (e.g., transarterial (chemo)embolization, radiofrequency ablation, percutaneous injection, cryoablation, high-intensity focused ultrasound, etc.), the target lesion must not have been treated with the above locoregional therapies, or the investigator has confirmed disease progression or absence of clinical benefit in the target lesion after prior locoregional therapy.
What they're measuring
1
To evaluate the safety and tolerability of ABSK-011 combined with atezolizumab mab in subjects with advanced or unresectable HCC
Timeframe: 10 month
2
To evaluate the objective response rate of ABSK-011 combined with atezolizumab in subjects with advanced FGF19 overexpression or unresectable HCC
Timeframe: 10month
3
To evaluate the safety and tolerability of ABSK-011 in combination with SOC in subjects with advanced or unresectable HCC, and to determine the dosing regimen for Stage 2 of Part C2.
Timeframe: 10month
4
To evaluate the preliminary efficacy of ABSK-011 in combination with toripalimab and bevacizumab in subjects with FGF19-overexpressing advanced or unresectable HCC.