A Study of Absorption, Metabolism, and Elimination CC-90010 in Participants With Advanced Solid Tumors

A Phase 1, 2-Part, Open-label Study to Determine the Absorption, Metabolism, and Elimination of [14C]CC-90010 in Participants With Advanced Solid Tumors

The purpose of this study is to assess the absorption, metabolism, and elimination of CC-90010 and its metabolites following a single oral dose of radiolabeled CC-90010 in participants with advanced solid tumors.

Study Overview

• Status: Withdrawn
• Conditions: Advanced Solid Tumors
• Intervention / Treatment: Drug: CC-90010; Drug: [14C]CC-90010

• Study Type: Interventional
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • M
    • Madrid, M, Spain, 28046
      • Local Institution - 0002

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Males ≥ 18 years of age
• Has histological or cytological confirmation of advanced solid tumors including those who have progressed on standard anticancer therapy or for whom no other approved conventional therapy exists
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1

Exclusion Criteria:

• Persistent diarrhea National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≥ 2
• History of concurrent second cancers requiring active and ongoing systemic treatment

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: CC-90010 followed by [14C]CC-90010	Drug: CC-90010; Specified dose on specified days; Other Names: BMS-986378; Drug: [14C]CC-90010; Specified dose on specified days
Experimental: Part 2: CC-90010	Drug: CC-90010; Specified dose on specified days; Other Names: BMS-986378

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total [14C]-radioactivity in whole blood, plasma, urine, and feces (and vomit, if applicable)	Up to 26 Days
Cumulative elimination of total [14C]-radioactivity (as a fraction of the radioactive dose) in urine and feces (and vomit, if applicable)	Up to 14 Days
Total [14C]-radioactivity whole blood to plasma ratios	Up to 26 Days
Peak plasma drug concentration (Cmax)	Up to 26 Days
Time to peak plasma drug concentration (Tmax)	Up to 26 Days
Area under the concentration-time curve from time zero to time the time of the last measurable concentration (AUC[0-T])	Up to 26 Days

Secondary Outcome Measures

Outcome Measure	Time Frame
Biotransformation of [14C]CC-90010 as [14C]-related metabolites in plasma, urine, and feces	Up to 26 Days
Number of participants with adverse events (AEs)	Up to 26 Months
Number of participants with physical examination abnormalities	Up to 26 Months
Number of participants with vital sign abnormalities	Up to 26 Months
Number of participants with electrocardiogram (ECG) abnormalities	Up to 26 Months
Number of participants with clinical laboratory abnormalities	Up to 26 Months

Collaborators and Investigators

• Sponsor: Bristol-Myers Squibb
• Investigators: Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

Helpful Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Study record dates

Study Major Dates

• Study Start (Estimated): January 9, 2023
• Primary Completion (Estimated): April 29, 2024
• Study Completion (Estimated): April 29, 2024

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: December 23, 2022
• First Posted (Actual): January 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Neoplasms; Solid Tumors; BET Inhibitor; CC-90010; [14C]CC-90010; BMS-986378
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CA076-001; 2021-005203-13 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosurecommitment.html.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No