Drugs / ABSK043

Trials 7

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT04964375 Aug 2021 → Oct 2022 neoplasm Abbisko Therapeutics Co, Ltd Unknown No outcome recorded
Phase 26 trials
Phase 2 NCT07710612 Aug 2026 → Dec 2029 expected non-small cell lung carcinoma Abbisko Therapeutics Co, Ltd Not yet recruiting No outcome recorded
Phase 2 NCT07164170 Sep 2025 → Dec 2028 expected non-small cell lung carcinoma Abbisko Therapeutics Co, Ltd Recruiting No outcome recorded
Phase 2 NCT07014137 Sep 2025 → Mar 2027 expected sarcoma University Health Network, Toronto Recruiting No outcome recorded
Phase 2 NCT06978933 Apr 2025 → Dec 2026 expected hepatocellular carcinoma RenJi Hospital Recruiting No outcome recorded
Phase 2 NCT06668103 Nov 2024 → Dec 2027 expected non-small cell lung carcinoma Abbisko Therapeutics Co, Ltd Recruiting No outcome recorded
Phase 2 NCT06632262 Nov 2024 → Nov 2029 expected gastroesophageal cancer, non-small cell lung carcinoma, urothelial carcinoma Abbisko Therapeutics Co, Ltd Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 6

DateIssuerRelease
2026-06-26 Abbisko Therapeutics Co, Ltd Results Abbisko Therapeutics Reports Phase II Data of ABSK061 in Combination with ABSK043 in FGFR2-Positive Advanced GC/GEJC Presented at ASCO 2026 abbisko.com ↗
The study demonstrated a favorable safety profile and promising anti-tumor activity of ABSK061 plus ABSK043, with or without CAPOX, in patients with FGFR2-positive advanced GC/GEJC
2025-12-08 Abbisko Therapeutics Co, Ltd Results Abbisko Therapeutics Presents Preliminary Phase II Results of Oral PD-L1 Inhibitor ABSK043 Combined with EGFR Inhibitor Firmonertinib for the Treatment of NSCLC at ESMO Asia 2025 abbisko.com ↗
Data showed that the combination demonstrated favorable safety and tolerability.
2025-08-21 Abbisko Therapeutics Co, Ltd Regulatory Abbisko Therapeutics Announces IND Clearance from the CDE for ABSK043 in Combination with Glecirasib from Allist Pharmaceuticals, for the Treatment of NSCLC abbisko.com ↗
2024-12-06 Abbisko Therapeutics Co, Ltd Results ESMO Asia 2024: Oral presentation by Abbisko Therapeutics on updated results from a phase 1 study of ABSK043, an oral PD-L1 inhibitor. abbisko.com ↗
The results of the study show that at 600mg -1000mg BID, ABSK043 demonstrated a favorable safety profile and impressive anti-tumor activity as a single agent.
2022-03-11 Abbisko Therapeutics Co, Ltd Results Abbisko Therapeutics Declared Two Next-Generation Precision Oncology Preclinical Candidates and Will Present Multiple Discovery and Translational Research Results at AACR Annual Meeting 2022 abbisko.com ↗
A potent and selective small molecule antagonist of PD-L1 ABSK043 demonstrates significant anti-tumor efficacy in combination with other agents in preclinical models
2021-07-12 Abbisko Therapeutics Co, Ltd Regulatory Abbisko Therapeutics Obtained Clinical Trial Approval for ABSK043 in Australia abbisko.com ↗
We are very happy to obtain the regulatory approval of ABSK043 in Australia, which is a critical first step for our following clinical trials.

All press releases naming this drug 15 releases

DateIssuerRelease

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 7 sources stand behind the page.

FieldValueCited text
Known as ABSK043 “ABSK043, is an orally available, selective and potent inhibitor targeting the interaction of PD-1 and PD-L1” NCT06978933 ↗
6

NCT04964375 ↗

NCT06668103 ↗

NCT07164170 ↗

NCT06632262 ↗

NCT07710612 ↗

NCT07014137 ↗

Action Inhibit “ABSK043 is a novel, oral small molecule inhibitor of PD-L1” NCT04964375 ↗
Modality Small molecule “ABSK043 is a novel, oral small molecule inhibitor of PD-L1” NCT04964375 ↗
Route Oral “For the Dose Expansion Phase, patients will each receive orally administered doses of ABSK043” NCT04964375 ↗