Clinical trial NCT06730750: A Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors
Official title: A Phase 1/2a, Multicenter, Open-label, First in Human Study of BMS-986490 With or Without Bevacizumab in Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
Keywords: Colorectal Cancer (CRC)
Non-small Cell Lung cancer (NSCLC)
Gastric Cancer (GC)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-12-12
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: Inclusion Criteria:

* Documented histologically or cytologically confirmed, advanced, unresectable/metastatic solid tumor measurable by RECIST v1.1.
* CRC: Part 1A, Part 2A-CRC, Part 1B, and Part 2B:.

  i) Locally advanced/metastatic, recurrent, or unresectable CRC with adenocarcinoma histology and whose disease has progressed after systemic cancer therapy in the metastatic or adjuvant setting including 5-FU, irinotecan, and/or oxaliplatin (if available and not contraindicated).
* NSCLC: Part 2A-NSCLC/GC, 3L+ NSCLC:.

  i) Histologically confirmed NSCLC meeting stage criteria for Stage IIIB, Stage IV, or recurrent disease.

ii) Progressed on at least 2 prior lines of therapy,

iii) Participants must have received and progressed on or after anti-PD-(L)1 therapy, if available.

- GC: Part 2A-NSCLC/GC, 2L+ GC:.

i) Participants must have received and then progressed or been intolerant to at least 1 standard treatment regimen in the advanced or metastatic setting (or have progressed within 6 months of adjuvant therapy).

ii) ECOG performance status of 0 or 1.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Number of participnats with Adverse Events (AEs)
timeFrame: Up to 100 days following discontinuation of dosing
measure: Number of participants with Serious AEs (SAEs)
timeFrame: Up to 100 days following discontinuation of dosing
measure: Number of participants with AEs meeting protocol-defined dose limiting toxicity (DLT) criteria
timeFrame: Up to 28 days after the first treatment of study intervention
measure: Number of participants with AEs leading to discontinuation
timeFrame: Up to 100 days following discontinuation of dosing
measure: Number of deaths
timeFrame: Up to 100 days following discontinuation of dosing
Secondary outcomes:
measure: Area under the concentration-time curve in 1 dosing interval (AUC(TAU))
timeFrame: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
measure: Trough observed concentration (Ctrough)
timeFrame: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
measure: Maximum observed concentration (Cmax)
timeFrame: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
measure: Time of maximum observed concentration (Tmax)
timeFrame: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
measure: Total anti-drug antibodies (ADAs)
timeFrame: Approximately 30 Days after Cycle 30, Day 1 (1 Cycle = 21 Days)
measure: Objective Response Rate (ORR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 assessed by Investigator
timeFrame: Up to approximately 4 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC/Norris Comprehensive Cancer Center
state: California
city: Grand Rapids
country: United States
facility: START Midwest
state: Michigan
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Pittsburgh
country: United States
facility: Local Institution - 0006
state: Pennsylvania
city: Southport
country: Australia
facility: Tasman Oncology Research
state: Queensland
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: