ClinicalTrials.gg
RecruitingNCT06433947Updated Oct 30, 2026

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

A Phase 1 interventional study of OPN-6602 and Dexamethasone in Relapsed Multiple Myeloma and Refractory Multiple Myeloma, sponsored by Opna Bio LLC. Recruiting at 12 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-30.

Sponsored by Opna Bio LLC · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Aug 2024; still recruiting 2 years 2 months later.
Updated Oct 30, 2026Primary completion movedStudy completion movedGo to Updates ↓

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Phase
Phase 1
Study type
Interventional
Enrollment
130
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 2,168 studies in Multiple Myeloma with a site in United States — 275 open to participants now, 503 under way, 66 of them phase 3. Multiple Myeloma · United States.

Planned enrollment
326th of 1,901
130 · median 36
Started
2024
with 78 others
Phase 1
559 of 2,168
64 open now
Primary completion
2027-12
later than 299 of 499 live
Registered
2,016th of 2,168
by date

Among the 2,168 studies in Multiple Myeloma with a site in United States, this one is the 326th largest by planned enrollment of the 1,901 interventional ones that give a count, is one of 79 that started in 2024, is one of 559 in phase 1, reaches primary completion later than 299 of the 499 other live ones, and was the 2,016th registered.

Multiple Myeloma

3,763 studies on the registry are indexed under Multiple Myeloma; 770 are open to participants now.

Browse Multiple Myeloma studies →

Open to participants now

275 of the 2,168 studies in Multiple Myeloma with a site in United States are open now. Recruiting first, the newest first:

270 more — sign in →

All 275 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 585 Multiple Myeloma studies recruiting now, 430 (74%) set no upper age limit and 106 (18%) stop at 75 or younger; 36 take children under 18; 24 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 2,168 studies in Multiple Myeloma with a site in United States, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Relapsed Multiple Myeloma
  • Refractory Multiple Myeloma

Browse trials for

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Confirmed diagnosis of multiple myeloma (MM)
  • to 3 or more different 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

Exclusion criteria

Exclusion Criteria:

  • 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 peripheral stem cell transplant or prior autologous bone marrow transplantation within \<90 days of the first dose of study drug
  • Prior allogeneic stem cell transplantation or solid organ transplantation within 12 months of first dose of study drug; subjects receiving 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 (except subjects on chronic steroids given for disorders other than myeloma)
  • Known central nervous system involvement by multiple myeloma
  • Active known second 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
Terms in these criteria, in plain language(6)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
130 participants (estimated)

Study arms

  • Experimental
    Dose escalation monotherapy

    Drug: OPN-6602

  • Experimental
    Dose escalation in combo with dexamethasone

    Drug: OPN-6602 · Drug: Dexamethasone

  • Experimental
    Dose expansion

    Drug: OPN-6602

Interventions

  • DrugOPN-6602

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

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

06

What researchers measure

Primary outcomes

  1. Number and type of dose-limiting toxicities (DLTs)

    Time frame: Through up to approximately 30 days following last dose of OPN-6602

  2. Number and type of treatment-emergent adverse events (TEAEs)

    Time frame: Through up to approximately 30 days following last dose of OPN-6602

  3. 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.

    Time frame: Through up to approximately 30 days following last dose of OPN-6602

07

Study locations

12 of 12 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2024 (actual). Primary completion is estimated for Dec 2027, 40 months after the start.

Of 212 industry-sponsored phase 1 interventional studies under Multiple Myeloma, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 27 and three quarters within 71. This study's planned 40 months is close to that.

Counting every sponsor, half of 413 studies reached it within 50 months; a quarter within 33 and three quarters within 75.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 30, 2026: primary completion Jul 2026 → Dec 2027 and completion Jul 2026 → Dec 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
May 23, 2024
First posted
May 30, 2024
StartActual
Aug 22, 2024
Primary completionEst.
Dec 2027was Jul 2026
CompletionEst.
Dec 2027was Jul 2026
Last update
Oct 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Jul 2026→Dec 2027
Oct 30, 2026
Study completion
Jul 2026→Dec 2027
Oct 30, 2026
Show all 1 update
  1. Oct 30, 2026
    Primary completion Jul 2026→Dec 2027
    Study completion Jul 2026→Dec 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06433947
Lead sponsor
Opna Bio LLC
Responsible party
Sponsor
First posted
May 30, 2024
Start date
Aug 22, 2024
Primary completion
Dec 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 30, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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