Health TrialsbyHealthPanel

A Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors

ConditionAdvanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBristol-Myers Squibb

About this trial

This is a study of BMS-986490 as a monotherapy and in combination with bevacizumab in participants with select advanced solid tumors known to express CEACAM5.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Documented histologically or cytologically confirmed, advanced, unresectable/metastatic solid tumor measurable by RECIST v1.1.

Disqualifiers

History of anaphylactic reactions to irinotecan and/or bevacizumab.

Previously received therapy targeting CEACAM5.

Grade ≥3 ILD/pneumonitis.

Other protocol-defined Inclusion/Exclusion criteria apply.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BMS-986490

    Drug

    Specified dose on specified days.

  • Bevacizumab

    Drug

    Specified dose on specified days.

Treatment groups

360 Participants
are divided into 5 treatment groups
Group A: Part 1AExperimental treatment 1 intervention
Group B: Part 2A - Colorectal Cancer (CRC)Experimental treatment 1 intervention
Group C: Part 2A - Non-Small Cell Lung Cancer/Gastric Cancer (NSCLC/GC)Experimental treatment 1 intervention
Group D: Part 1BExperimental treatment 2 interventions
Group E: Part 2BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Number of participnats with Adverse Events (AEs)

Time frame
Up to 100 days following discontinuation of dosing
2

Number of participants with Serious AEs (SAEs)

Time frame
Up to 100 days following discontinuation of dosing
3

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

Time frame
Up to 28 days after the first treatment of study intervention
4

Number of participants with AEs leading to discontinuation

Time frame
Up to 100 days following discontinuation of dosing

Secondary outcomes

1

Area under the concentration-time curve in 1 dosing interval (AUC(TAU))

Time frame
Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
2

Trough observed concentration (Ctrough)

Time frame
Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
3

Maximum observed concentration (Cmax)

Time frame
Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
4

Time of maximum observed concentration (Tmax)

Time frame
Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)

Other outcomes

Sponsors and contacts

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

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov
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