Clinical trials

This study consists of two parts: Part A and Part B. Part A is a single-center, randomized, open-label, three-period study intended to evaluate the effects of low-fat and high-fat meals on the pharmacokinetic profiles of ABSK-011 Capsules. A total of 15 healthy participants are planned to be enrolled. Participants will be randomized to Sequence A, Sequence B or Sequence C at a 1:1:1 ratio and receive a single oral dose of ABSK-011 (50 mg × 4) on three separate occasions with a 4-day washout interval between administrations. 39 PK blood sampling time points will be collected in Part A. Part B is a single-center, open-label, fixed-sequence study designed to assess the impact of multiple oral doses of omeprazole enteric-coated tablets on the pharmacokinetic profiles of ABSK-011 Capsules. 15 healthy participants are planned for enrollment. On Day 1 of Cycle 1 (C1D1), participants will receive 200 mg ABSK-011 Capsules in the morning after a low-fat meal. From Day 1 to Day 5 of Cycle 2 (C2D1-C2D5), participants will take 40 mg omeprazole enteric-coated tablets orally once daily under fasted conditions. 26 PK blood sampling time points will be collected in Part B.

This is a first-in-human (FIH), multicenter, open-label, phase I study of ABSK211 in participants with advanced solid tumors to evaluate safety, tolerability, PK and optimize the dosage.

This is a phase 2, open-Label study to evaluate the efficacy and safety of ABSK043 Combined with Osimertinib in participants with EGFR-Mutated locally advanced or metastatic Non-Small Cell Lung Cancer

This is a multicenter, open-label phase 2 study that will enroll KRASG12C mutated patients with locally advanced or metastatic NSCLC, receiving treatment (ABSK043 in combination with Glecirasib) in a 21-day combination cycle.

This is an open-label phase 1 study with an escalation part and an expansion part.

This is an open-label phase 1 study to determine the safety and tolebility of oral ABSK021 in patients with advanced solid tumor as well as the Recommended Phase 2 dose (RP2D) of oral ABSK021. Preliminary antitumor activity will also be assessed.

This is a first-in-human (FIH), exploratory, multicenter, open-label, phase I/II study of ABSK141 in patients with advanced solid tumors to to evaluate safety, tolerability, PK and optimize the dosage.

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.

This is a multicenter, non-randomized, open-label, phase I/II study in children with ACH. This study will start with a dose escalation of ABSK061 in children with ACH to evaluate the safety, tolerability, PK, and efficacy. The RDE confirmation part will evaluate the safety and efficacy of ABSK061 at the recommended doses for expansion (RDEs) in children with ACH. All patients enrolled in the dose escalation part and RDE confirmation part can enter the extended treatment period to further evaluate the long-term safety, tolerability, and long-term efficacy of ABSK061 in children with ACH.

The goal of this observational study is to collect the anthropometric parameters, clinical characteristics, related medical complications, health-related quality of life and treatments of children with ACH, and complete a natural history observation of ACH for at least 6 months and up to 2 years.

This is a first-in-human (FIH), multicenter, non-randomized, openlabel, phase 1 study of ABSK131 in patients with MTAP-Deficient Advanced/Metastatic Solid Tumors to evaluate the safety, tolerability, PK, and preliminary antitumor efficacy.

This study is a single-site, open-label, single-cohort, single-dose study to assess the absorption, metabolism, and excretion profile of \[14C\] ABSK011 in healthy adult male subjects. The study plans to enroll 6 to 8 healthy male subjects to ensure at least 6 evaluable subjects.

This is an open-label phase 2 study to evaluate the safety, tolerability and preliminary anti-tumour activity of ABSK043 in combination with Firmonertinib in patients with Epidermal Growth Factor Receptor-mutated (EGFRm+) locally advanced or metastatic NSCLC.

The purpose of this study is to evaluate the anti-tumor activity of ABSK061 + ABSK043 in terms of overall response rate (ORR) in in Patients with Metastatic/Unresectable Solid Tumors with FGFR2/3 Alterations

This is an open-label phase 1 study with expansion. The study will start with a dose escalation of single-agent ABSK061 administered in repeated 28-day cycles in patients with advanced solid tumors to evaluate safety and tolerability. The expansion part will investigate oral ABSK061 at the recommended dose for expansion (RDE) to further evaluate safety and tolerability among selected tumor types. Preliminary antitumor activity will also be assessed.

The goal of this clinical trial is to assess the efficacy and safety of Pimicotinib (ABSK021) in combination with chemotherapy with or without Toripalimab in patients with advanced pancreatic cancer. The main questions it aims to answer are: * Whether the Pimicotinib (ABSK021) in combination with chemotherapy with or without Toripalimab is safe in patients with advanced pancreatic cancer. * Whether the Pimicotinib (ABSK021) in combination with chemotherapy with or without Toripalimab is effective in patients with advanced pancreatic cancer. Participants will be asked to complete the study procedures: * Receive the administration of Pimicotinib (ABSK021) in combination with chemotherapy with or without Toripalimab about 24 weeks in study Part A or Part B. * Receive the administration of Pimicotinib(ABSK021) about 24 weeks in study part 2. * Complete the study procedures specified in the protocol, which is guided by researchers.

This is a first-in-human (FIH), multicenter, non-randomized, openlabel, phase 1 study of ABSK112 in patients with NSCLC to evaluate the safety, tolerability, PK, and preliminary antitumor efficacy.