Trials / Recruiting
RecruitingNCT06433947
Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 130 (estimated)
- Sponsor
- Opna Bio LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2024-08-22
- Primary completion
- 2026-07-01
- Completion
- 2026-07-01
- First posted
- 2024-05-30
- Last updated
- 2026-04-13
Locations
11 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06433947. Inclusion in this directory is not an endorsement.