BioAtla has presented first-in-human Phase I study data of its anti-cancer therapy, BA3182, targeting those with treatment-refractory metastatic adenocarcinoma.
The findings were shared in a poster presentation at the European Society for Medical Oncology (ESMO) Gastrointestinal Cancers Congress in Barcelona, Spain, from 2-5 July 2025.
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The ongoing Phase I clinical trial aims to establish the safety and optimal dosing for further study in Phase II.
As of 20 June 2025, 39 subjects with heavily pretreated metastatic adenocarcinoma received dosing in the study in the cohorts spanning from 0.0026mg to 0.6mg once-weekly (QW) doses of the therapy.
The primary aim is to determine the safety and tolerability of escalating doses of the therapy to inform the recommended Phase II dose.
Secondary objectives involve assessing preliminary antitumour activity, pharmacokinetics, and potential immunogenicity.
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By GlobalDataThe trial included patients who had undergone a median of three previous therapy lines, with tumour types spanning a range of adenocarcinomas, including adenoid cystic carcinoma, breast, gallbladder, and ovarian.
Notably, 56% of the subjects had colorectal carcinoma. BA3182 was administered intravenously to 17 subjects and subcutaneously to 22, revealing an improved plasma profile for subcutaneous dosing.
Adverse events were found to be predominantly low-grade and manageable. Cytokine Release Syndrome was found only with intravenous dosing before the prophylactic tocilizumab implementation.
Additionally, transient hepatic transaminase elevations were noted but did not delay subsequent weekly doses.
Objective tumour size decreases were achieved in five subjects across various cancer types, with two colorectal carcinoma subjects experiencing progression-free intervals of 11 and 14 months.
The dose escalation continues with 1.2mg flat dosing, with updated Phase I data expected in the second half of this year.
BioAtla CEO, chairman, and co-founder Jay Short said: “BA3182, our dual-conditionally active biologic (CAB) epithelial cell adhesion molecule (EpCAM) × CD3 bispecific TCE, was developed to drive maximal binding in the acidic tumour microenvironment, effectively eliminating binding in healthy tissues, and thereby avoiding on-target, off-tumour toxicities observed by others in previous attempts with EpCAM targeting antibodies.
“We are observing encouraging preliminary tumour reductions and a reassuring safety profile, and continue to dose escalate.”
