A Phase 1/2a Study of BMS-986507 (BL-B01D1) in Adult Participants with Advanced Solid Tumors

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Neoplasms [C04]

Trial duration

18 Jun 2025 → ongoing

Decision date (initial)

2025-11-07

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-514947-27-00

WHO UTN

U1111-1308-2752

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Dose response, Pharmacokinetic

Find out if BMS-986507 is safe and to determine the maximum dose that is safe for being given to the patients in combination with other treatments and select some safe doses to be evaluated in a large group of patients. BMS-986507 will be evaluated in two groups of lung cancer patients: patients with a type of lung cancer called EGFRmt non-small cell lung cancer (NSCLC) and patients with a type of lung cancer called EGFRwt NSCLC.

Secondary objectives 1

1. Learn how BMS-986507 behaves in the body when it is administered combined with other treatments in Group A and Group B to understand how BMS-986507 moves through and affects the body when used with these other drugs.

Conditions and MedDRA coding

Advance solid tumors

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Participants must have at least one measurable lesion per response evaluation criteria in solid tumors.
2. Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.
3. Participants must have a life expectancy of at least 3 months at the time of the first dose.

Exclusion criteria 5

1. Participants must not have any mixed Small Cell Lung Cancer (SCLC) and Non-Small Cell Lung Cancer (NSCLC) histology.
2. Participants with spinal cord compression, symptomatic central nervous system (CNS) metastases, progression of existing CNS metastases, or the appearance of new lesions as shown on CNS imaging during screening will be excluded.
3. Participants must not have a history of serious recurrent infections.
4. Participants must not have a history of severe heart disease.
5. Other protocol-defined Inclusion/Exclusion criteria apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 6

1. Number of participants with adverse events (AEs)
2. Number of participants with serious adverse events (SAEs)
3. Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) critera
4. Number of participants with AEs leading to discontinuation
5. Number of participants with AEs leading to death
6. Number of DLTs that occur during the DLT evaluation period

Secondary endpoints 6

1. Maximum observed serum concentration (Cmax)
2. Time of maximum observed concentration (Tmax)
3. Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
4. Area under the serum concentration-time curve within a dosing interval (AUC(TAU))
5. Objective response rate (ORR)
6. Best Overall Response (BOR)

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Bristol-Myers Squibb Services Unlimited Company

Sponsor organisation

Bristol-Myers Squibb Services Unlimited Company

Address

Plaza 254 Blanchardstown Corporate Park 2

City

Dublin 15

Postcode

D15 T867

Country

Ireland

Scientific contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Public contact point

Organisation

Bristol-Myers Squibb Services Unlimited Company

Contact name

GSM-CT

Third parties 10

Locations

4 EU/EEA countries · 24 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 38 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

7 submissions — initial application plus substantial / non-substantial modifications