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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Opna Bio LLC
Study ID
NCT06433947
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Refractory Multiple Myeloma
  • Relapsed Multiple Myeloma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OPN-6602 — DRUG
    orally active, small molecule inhibitor of EP300 and CBP bromodomain; dosed daily
  • Dexamethasone — DRUG
    Synthetic glucocorticoid; 40 mg Days 1, 8, 15 of each cycle

Study Details

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.

Key Dates

First listed
May 30, 2024
Start date
Aug 22, 2024
Status verified
May 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
130 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation monotherapy
  • Experimental: Dose escalation in combo with dexamethasone
  • Experimental: Dose expansion

Primary Outcome Measure

Number and type of dose-limiting toxicities (DLTs) [ Time Frame: Through up to approximately 30 days following last dose of OPN-6602 ]

Locations (12)

FacilityCityStateZIPSite coordinators
Banner MD AndersonGilbertArizona85234
Brett Post
[email protected]
480-256-3116
UC San Diego Moores Cancer CenterLa JollaCalifornia92093-0698
Rebecca Jimenez
[email protected]
858-822-5377
Stanford Cancer InstituteStanfordCalifornia94305
Caitlyn Minas
[email protected]
650-723-0646
Emory Winchip Cancer CenterAtlantaGeorgia30322
Megan Marshall
[email protected]
404-778-5204
University of Kansas Clinical Research CenterWestwoodKansas66205
Nurse Navigation
[email protected]
913-945-7552
Dana Farber Cancer InstituteBostonMassachusetts02215
Yuxin Liu
[email protected]
877-422-3324
Karmanos Cancer InstituteDetroitMichigan48201
Kate Staub
[email protected]
313-576-8736
START MidwestGrand RapidsMichigan49546
Julie Burns
[email protected]
616-954-5559
University of Rochester Medical CenterRochesterNew York14642
Liu
[email protected]
585-275-5823
University of North Carolina Hospitals at HillsboroughChapel HillNorth Carolina27599
Brice Messenger, CCRP
[email protected]
919-966-4432
Huntsman Cancer Center Institute University of UtahSalt Lake CityUtah84112
Collind Boyington
[email protected]
801-587-4779
Fred Hutchinson Cancer CenterSeattleWashington98109
Danai Dima
[email protected]
855-557-0555

Find similar trials in Gilbert, AZ

By research site
Banner MD Anderson· Gilbert, AZUC San Diego Moores Cancer Center· La Jolla, CAStanford Cancer Institute· Stanford, CAEmory Winchip Cancer Center· Atlanta, GAUniversity of Kansas Clinical Research Center· Westwood, KSDana Farber Cancer Institute· Boston, MA

Related Studies