ABL Bio completes early patient enrollment for phase 1b 피망 바카라 expansion trial of ABL111 combination therapy

[by Kang, In Hyo] ABL Bio, a company specializing in the development of bispecific antibodies, announced on August 12 that it has completed early patient enrollment for the Phase 1b ‘피망 바카라 Expansion Part’ clinical trial of ‘ABL111’ (development code, givastomig), a combination therapy co-developed with the U.S. biopharmaceutical company I-Mab.

Currently, ABL111 is being evaluated as a first-line treatment for patients with claudin 18.2-positive gastric cancer (≥1% of cancer cells expressing ≥1+) in combination with the PD-1 immunotherapy ‘nivolumab’ and the chemotherapy regimen ‘Folfox’ (mFOLFOX6).

ABL Bio and I-Mab intend to assess the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of the ABL111 combination therapy through this Phase 1b clinical trial, with safety designated as the primary endpoint. This trial is currently being conducted in gastric cancer patients in the United States. A total of 40 patients have been enrolled in two 피망 바카라 groups, 8 mg/kg and 12 mg/kg, which will be evaluated through the 피망 바카라 Expansion Part.

"In the ‘피망 바카라 Escalation Part,’ the ABL111 combination therapy achieved an objective response rate (ORR) of 71% (12/17) and a disease control rate (DCR) of 100% (17/17)," said Lee Sang-hoon, CEO of ABL Bio. "In particular, the 8 mg/kg and 12 mg/kg 피망 바카라 groups recorded an ORR of 83% (10/12)."

"We anticipate that the 피망 바카라 Expansion Part, scheduled for release in the first quarter of 2026, will also be positive," Lee further commented. "As the clinical development of the ABL111 combination therapy gains momentum, we will likewise accelerate the clinical trials of combinations with other bispecific antibodies developed using our 4-1BB-based bispecific antibody platform, 'Grabody-T.’"

"The faster-than-expected patient enrollment in this Phase 1b trial reflects the dedication of researchers working to improve the gastric cancer treatment landscape and the strong industry interest in claudin 18.2-targeted therapies,” expressed Dr. Phillip Dennis, Chief Medical Officer (CMO) at I-Mab. “The data from the Phase 1b 피망 바카라 escalation part, presented at the European Society for Medical Oncology (ESMO GI) Congress in July, are highly encouraging, and we look forward to ABL111 emerging as a new treatment option for gastric cancer patients," he added.

ABL111 is a bispecific antibody built on ABL Bio’s 4-1BB-based bispecific antibody platform, Grabody-T. it is engineered to activate immune T cells exclusively in the tumor microenvironment where claudin 18.2 is expressed. These activated T cells then selectively target claudin 18.2-positive tumor cells while sparing normal cells, thereby reducing the risk of on-target, off-tumor toxicity.