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

NCT06433947
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Recruiting
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Participants
130
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Lead sponsor
Opna Bio LLC
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Start date
2024-08-22
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Number of sites
12
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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.
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Short title
Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
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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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2027-12-01
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First posted
2024-05-30
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Registry last updated
2026-10-30
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Primary completion date
2027-12-01
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Start date
2024-08-22
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Participants
130
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Participant count basis
Estimated
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Planned participants
130
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Protocol amendments
5
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Number of sites
12
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Opna Bio LLC
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06433947
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ClinicalTrials.gov ID
NCT06433947
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Registry record
Open registry record
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Allocation
Not randomised
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

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

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

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

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

  3. Number of Participants With Clinical Laboratory Test Abnormalities

    Timeframe: 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.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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
  • 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
Sources for eligibility
clinicaltrials.gov

  • Banner MD AndersonGilbert, United StatesRecruiting
  • UC San Diego Moores Cancer CenterLa Jolla, United StatesRecruiting
  • Stanford Cancer InstituteStanford, United StatesRecruiting
  • Emory Winchip Cancer CenterAtlanta, United StatesRecruiting
  • University of Kansas Clinical Research CenterWestwood, United StatesRecruiting
  • Dana Farber Cancer InstituteBoston, United StatesRecruiting
  • Karmanos Cancer InstituteDetroit, United StatesRecruiting
  • START MidwestGrand Rapids, United StatesRecruiting
  • University of Rochester Medical CenterRochester, United StatesRecruiting
  • University of North Carolina Hospitals at HillsboroughChapel Hill, United StatesRecruiting
  • Huntsman Cancer Center Institute University of UtahSalt Lake City, United StatesRecruiting
  • Fred Hutchinson Cancer CenterSeattle, United StatesRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (2)