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Phase I study of BI 765049 in advanced gastrointestinal cancers (NCT06882746)

 

Phase I, open-label, non-randomized, multi-center dose escalation trial of BI 765049 administered by parenteral route in patients with advanced, unresectable, and/or metastatic colorectal carcinoma, gastric carcinoma, or PDAC to determine the MTD and the RP2D and to determine the dosing regimen for further development of BI 7650491

B7-H6/CD3 antibody: NCT06882746 (1454-0015)
B7-H6/CD3 antibody: NCT06882746 (1454-0015)

AUCτ, area under the curve during a dosage interval; Cmax, peak serum concentration; CNS, central nervous system; CRC, colorectal cancer; DLT, dose-limiting toxicity; ECOG PS, Eastern Cooperative Oncology Group performance status; MTD, maximum tolerated dose; OR, objective response; PDAC, pancreatic ductal adenocarcinoma; PK, pharmacokinetic; RECIST, Response Evaluation Criteria in Solid Tumours; RP2D, recommended Phase II dose.

References

  1. ClinicalTrials.gov. NCT06882746. https://clinicaltrials.gov/study/NCT06882746 (Accessed: February 2026).