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RECRUITING
NCT06433947
PHASE1

Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma

Sponsor: Opna Bio LLC

View on ClinicalTrials.gov

Summary

Phase 1b, open-label study evaluating the safety, tolerability, pharmacokinetics, preliminary antitumor activity, and pharmacodynamics of OPN-6602 monotherapy and in combination with dexamethasone in subjects with relapsed and/or refractory MM.

Official title: A Phase 1b, Dose Escalation/Dose Expansion, Multicenter, Open-Label Study to Assess the Safety and Tolerability of OPN-6602 Monotherapy and in Combination With Dexamethasone in Subjects With Relapsed and/or Refractory Multiple Myeloma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

130

Start Date

2024-08-22

Completion Date

2026-07

Last Updated

2025-08-19

Healthy Volunteers

No

Interventions

DRUG

OPN-6602

orally active, small molecule inhibitor of EP300 and CBP bromodomain; dosed daily

DRUG

Dexamethasone

Synthetic glucocorticoid; 40 mg Days 1, 8, 15 of each cycle

Locations (10)

Banner MD Anderson

Gilbert, Arizona, United States

Stanford Cancer Institute

Stanford, California, United States

Emory Winchip Cancer Center

Atlanta, Georgia, United States

University of Kansas Clinical Research Center

Westwood, Kansas, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Karmanos Cancer Institute

Detroit, Michigan, United States

START Midwest

Grand Rapids, Michigan, United States

University of Rochester Medical Center

Rochester, New York, United States

Huntsman Cancer Center Institute University of Utah

Salt Lake City, Utah, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States