A Study to Evaluate the Safety, Tolerability, and Efficacy of Escalating Doses of BMS-986463 in Participants With Select Advanced Malignant Tumors.

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

The purpose of this study is to evaluate the safety, tolerability, and efficacy of escalating doses of BMS-986463 in participants with select advanced malignant tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.

Participants must have at least 1 lesion accessible for biopsy in addition to the target lesion, from which a fresh pre treatment biopsy must be obtained.

Participants must have an unresectable/metastatic carcinoma.

Disqualifiers

Participants must not have Leptomeningeal metastases.

Participants must not have concurrent malignancy (present during screening) requiring treatment or history of prior malignancy active within 2 years prior to treatment.

Participants must not have had any prior radiation therapy within 2 weeks prior to start of study treatment.

Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Design model

Sequential

Treatments tested in this trial

  • BMS-986463

    Drug

    Specified dose on specified days

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: Arm 1: Dose EscalationExperimental treatment 1 intervention
Group B: Arm 2: Dose ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with adverse events (AEs)

Time frame
Up to 108 weeks
2

Number of participants with serious adverse events (SAEs)

Time frame
Up to 108 weeks
3

Number of participants with AEs meeting protocol defined dose-limiting toxicity (DLT) criteria

Time frame
Up to 108 weeks
4

Number of participants with AEs leading to discontinuation

Time frame
Up to 108 weeks

Secondary outcomes

1

Maximum observed concentration (Cmax)

Time frame
Up to 104 weeks
2

Area under the concentration-time curve (AUC)

Time frame
Up to 104 weeks
3

Time of maximum observed concentration (Tmax)

Time frame
Up to 104 weeks
4

Objective response rate (ORR)

Time frame
Up to 104 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.