Phase 1/1b Study of BMS‑986463 in Patients With Advanced Malignant Tumors Including High‑Grade Serous Ovarian Carcinoma, Uterine Serous Carcinoma, and NSCLC

The trial enrolled 35 individuals diagnosed with advanced malignant tumors, specifically high‑grade serous ovarian carcinoma, uterine serous carcinoma, or non‑small cell lung cancer. Both female and male patients were eligible, and enrollment was limited to adult participants as defined by the protocol’s age‑range categories. Subjects were selected on the basis of a confirmed histological diagnosis of one of the specified tumor types and were classified as patients rather than healthy volunteers. General health status required participants to be otherwise medically stable to undergo study procedures. No additional lifestyle restrictions, such as specific diet or exercise regimens, were stipulated in the protocol. Key inclusion criteria centered on disease stage and histology, while exclusion criteria excluded individuals with concurrent malignancies or conditions that could confound safety assessments.

The study is a Phase 1/1b dose‑finding and expansion trial of BMS‑986463 in participants with advanced malignant tumors, including High‑grade Serous Ovarian Carcinoma, uterine serous carcinoma, and non‑small cell lung cancer. The protocol uses a sequential dose‑escalation design followed by expansion cohorts; allocation to dose level is determined by a predefined algorithm rather than randomization, and the trial is open‑label. Recruitment is scheduled to begin 1 August 2026 and to conclude 7 January 2032, resulting in an overall trial duration of approximately five and a half years. Study procedures commence with a screening visit to confirm eligibility, obtain baseline laboratory and imaging assessments, and document prior therapies. Eligible participants then enter the treatment period, during which dosing visits occur at regular intervals and include safety monitoring, pharmacokinetic sampling, and tumor assessments. Follow‑up visits are conducted at predefined time points after the last dose to evaluate continued safety and disease status, culminating in an end‑of‑study visit that includes final assessments and study discontinuation procedures. Participant involvement extends from the screening visit through the end‑of‑study visit, with the total duration of individual participation dependent on the dosing schedule and follow‑up period. Early termination of individual participation may occur if predefined criteria are met, such as disease progression, occurrence of a grade ≥ 3 treatment‑related adverse event, withdrawal of consent, or investigator decision based on clinical judgment.