Relapsed Multiple MyelomaPhase 1NCT06433947
Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
A Phase 1 study testing OPN-6602 and Dexamethasone in people with Relapsed Multiple Myeloma and Refractory Multiple Myeloma, run by Opna Bio LLC at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed Multiple Myeloma, Refractory Multiple Myeloma
- What is being tested?
- OPN-6602 and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 12 sitesUnited States
- Study dates
- 22 Aug 2024to Dec 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of multiple myeloma (MM)
- Relapsed or refractory to 3 or more different prior lines of therapy for MM that included immunomodulatory agents, proteosome inhibitors, and anti-CD38 antibody and not a candidate for or intolerant to established therapy known to provide clinical benefit
- Adequate hematologic, renal, liver, cardiac function
Who cannot join
- Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, Waldenström's macroglobulinemia, or IgM myeloma
- Active plasma cell leukemia
- Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS syndrome)
- Prior Stevens Johnson syndrome
- Localized radiation therapy to disease site(s) within 2 weeks of the first dose
- Prior autologous peripheral stem cell transplant or prior autologous bone marrow transplantation within <90 days of the first dose of study drug
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- Prior allogeneic stem cell transplantation or solid organ transplantation within 12 months of first dose of study drug; subjects receiving immunosuppressive medication for active graft vs host disease will be excluded.
- Prior chemotherapy, targeted anticancer or radiation therapy within 2 weeks prior to first dose of study drug
- Concomitant high-dose corticosteroids (except subjects on chronic steroids given for disorders other than myeloma)
- Known central nervous system involvement by multiple myeloma
- Active known second malignancy with exception of adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, or in situ cervical cancer; adequately treated Stage 1 cancer from which the subject is currently in remission and has been in remission for ≥2 years; low-risk prostate cancer with a Gleason score <7 and a PSA level <10 ng/mL; any other cancer from which the subject has been disease-free for ≥3 years
- Ongoing systemic infection requiring parenteral treatment
- Poorly controlled Type 2 diabetes
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
Emory Winchip Cancer Center
Atlanta, Georgia, 30322
Megan Marshall, 404-778-5204, megan.marshall@emory.edu
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Yuxin Liu, 877-422-3324, yuxin_liu@dfci.harvard.edu
- Recruiting
University of North Carolina Hospitals at Hillsborough
Chapel Hill, North Carolina, 27599
Brice Messenger, CCRP, 919-966-4432, brice_messenger@med.unc.edu
- Recruiting
Karmanos Cancer Institute
Detroit, Michigan, 48201
Kate Staub, 313-576-8736, staubk@karmanos.org
- Recruiting
Banner MD Anderson
Gilbert, Arizona, 85234
Brett Post, 480-256-3116, brett.post@bannerhealth.com
- Recruiting
START Midwest
Grand Rapids, Michigan, 49546
Julie Burns, 616-954-5559, Julie.burns@startresearch.com
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093-0698
Rebecca Jimenez, 858-822-5377, rejimenez@health.ucsd.edu
- Recruiting
University of Rochester Medical Center
Rochester, New York, 14642
Liu, 585-275-5823, wcicto@urmc.rochester.edu
- Recruiting
Huntsman Cancer Center Institute University of Utah
Salt Lake City, Utah, 84112
Collind Boyington, 801-587-4779, collind.boyington@hci.utah.edu
- Recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Danai Dima, 855-557-0555, ddima@fredhutch.org
- Recruiting
Stanford Cancer Institute
Stanford, California, 94305
Caitlyn Minas, 650-723-0646, cminas@stanford.edu
- Recruiting
University of Kansas Clinical Research Center
Westwood, Kansas, 66205
Nurse Navigation, 913-945-7552, CTNurseNav@kumc.edu
About this study
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
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.
- Being tested
- OPN-6602, Dexamethasone
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPN-6602Drug
orally active, small molecule inhibitor of EP300 and CBP bromodomain; dosed daily
DexamethasoneDrug
Synthetic glucocorticoid; 40 mg Days 1, 8, 15 of each cycle
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation monotherapy | Experimental | Not described Receives: Drug: OPN-6602 |
| Dose escalation in combo with dexamethasone | Experimental | Not described Receives: Drug: OPN-6602; Drug: Dexamethasone |
| Dose expansion | Experimental | Not described Receives: Drug: OPN-6602 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and type of dose-limiting toxicities (DLTs)
Measured: Through up to approximately 30 days following last dose of OPN-6602
Number and type of treatment-emergent adverse events (TEAEs)
Measured: Through up to approximately 30 days following last dose of OPN-6602
Number of Participants With Clinical Laboratory Test Abnormalities
Number of participants who experienced a clinical laboratory test abnormality, including hematology and serum chemistry, and coagulation. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Measured: Through up to approximately 30 days following last dose of OPN-6602
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start22 Aug 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Opna Bio LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433947
- Sponsor's protocol ID
- OPN6602-C01
- Status last verified
- Oct 2026
- First submitted
- 23 May 2024
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06433947
- Acronym / sponsor ID
- OPN6602-C01
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Opna Bio LLCIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 30 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dose escalation monotherapy | Experimental | Drug: OPN-6602 |
| Dose escalation in combo with dexamethasone | Experimental | Drug: OPN-6602, Drug: Dexamethasone |
| Dose expansion | Experimental | Drug: OPN-6602 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Confirmed diagnosis of multiple myeloma (MM)
- Relapsed or refractory to 3 or more different prior lines of therapy for MM that included immunomodulatory agents, proteosome inhibitors, and anti-CD38 antibody and not a candidate for or intolerant to established therapy known to provide clinical benefit
- Adequate hematologic, renal, liver, cardiac function
Key exclusion criteria (13 listed)
- Monoclonal gammopathy of undetermined significance (MGUS), smoldering myeloma, Waldenström's macroglobulinemia, or IgM myeloma
- Active plasma cell leukemia
- Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin changes (POEMS syndrome)
- Prior Stevens Johnson syndrome
- Localized radiation therapy to disease site(s) within 2 weeks of the first dose
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OPN-6602orally active, small molecule inhibitor of EP300 and CBP bromodomain; dosed daily | Drug | Dose escalation in combo with dexamethasone, Dose escalation monotherapy, Dose expansion |
| DexamethasoneSynthetic glucocorticoid; 40 mg Days 1, 8, 15 of each cycle | Drug | Dose escalation in combo with dexamethasone |
Primary outcome
Number and type of dose-limiting toxicities (DLTs)
Time frame: Through up to approximately 30 days following last dose of OPN-6602
Number and type of treatment-emergent adverse events (TEAEs)
Time frame: Through up to approximately 30 days following last dose of OPN-6602
Number of Participants With Clinical Laboratory Test Abnormalities
Time frame: Through up to approximately 30 days following last dose of OPN-6602
Number of participants who experienced a clinical laboratory test abnormality, including hematology and serum chemistry, and coagulation. Abnormalities considered are those Grade 3-4 events with a >= 1 grade increase from baseline using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing OPN-6602 and Dexamethasone in people with Relapsed Multiple Myeloma and Refractory Multiple Myeloma, run by Opna Bio LLC at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.