Recruiting NCT07160725

A Phase 1/2a, First-in-human, Study of BMS-986517 in Participants With Advanced Solid Tumors

Phase I / Phase II Interventional Solid Tumours

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: BMS-986517, Pumitamig.
Who it may be relevant to: Registry conditions: Solid Tumours. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Denmark, Japan, Spain
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Official title

A Phase 1/2a, First-in-human, Open-label Study of BMS-986517 as Monotherapy or Combination Therapy in Adult Participants With Advanced Solid Tumors

A phase 1/2a, open-label, first-in-human study mainly aimed to evaluate the safety and tolerability of BMS-986517 in participants with solid tumors

Number of Participants with Adverse Events (AE) [Time frame: Up to approximately 2 years]
Number of Participants with Serious Adverse Events (SAE) [Time frame: Up to approximately 2 years]
Number of Participants with AEs meeting protocol-defined Dose-limiting Toxicities (DLTs) criteria [Time frame: Up to Day 21]
Number of Participants with AEs Leading to Discontinuation [Time frame: Up to approximately 2 years]
Number of Participants with AEs Leading to Deaths [Time frame: Up to approximately 2 years]

Secondary outcome measures (6)

Objective Response Rate (ORR) Assessed by RECIST v1.1 per investigator assessment [Time frame: Up to approximately 3 years]
Duration of Response (DOR) Assessed by RECIST v1.1 per investigator assessment [Time frame: Up to approximately 3 years]
Maximum Plasma Concentration (Cmax) [Time frame: Up to approximately 2 years]
Time to Reach Maximum Plasma Concentration (Tmax) [Time frame: Up to approximately 2 years]
Area Under Curve (AUC) [Time frame: Up to approximately 2 years]
Total anti-drug antibodies (ADAs) [Time frame: Up to approximately 2 Years]

Participants must have an ECOG performance status of 0 to 1.
Participants must have measurable disease by RECIST v1.1 (radiologically measured by the Investigator).
Participants must have documented histologically or cytologically confirmed advanced, unresectable/metastatic solid tumors, including NSCLC, HNSCC, TNBC, and HR+/HER2- breast cancer.

Participants are eligible if CNS metastases have been treated and do not require immediate treatment or have been treated and have neurologically returned to baseline (except for residual signs or symptoms related to the CNS treatment).
Participants must not have concurrent malignancy (present during Screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment assignment.
Participants must not have history of serious recurrent infections.
Participants must not have impaired cardiac function or history of severe heart disease.
For participants in Part 1B and 2B: Active autoimmune disease or requirement for systemic immunosuppressive therapy.
For participants in Part 1B and 2B: History of interstitial lung disease (ILD) or pneumonitis requiring systemic steroids, or current/suspected ILD/pneumonitis.
For participants in Part 1B and 2B: Significant risk of hemorrhage, including tumor invasion of major vessels or recent clinically significant bleeding.
Other protocol-defined Inclusion/Exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 9 centers

Local Institution - 0033 — Irvine
USC/Norris Comprehensive Cancer Center — Los Angeles
University of California, Irvine (UCI) Health - UC Irvine Medical Center — Orange
UPMC Hillman Cancer Center — Pittsburgh
Sanford Cancer Center — Sioux Falls
START - Dallas Fort Worth — Fort Worth
START San Antonio — San Antonio
START Mountain Region — West Valley City
… and 1 more center

Spain · 6 centers

Denmark · 3 centers

Japan · 1 center

NCT: NCT07160725 · CA254-0001 · EU CTR · WHO