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

Refractory Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06433947
• Other study ID #: OPN6602-C01
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 2024
• Est. completion date: July 2026

Study information

• Verified date: May 2024
• Source: Opna Bio LLC
• Contact: Kerry Inokuchi
• Phone: 650-204-4065
• Email: kinokuchi[@]opnabio.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 130
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

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 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 screening; 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

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell
• Refractory Multiple Myeloma
• Relapsed Multiple Myeloma

Intervention

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

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Opna Bio LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and type of dose-limiting toxicities (DLTs)		Through up to approximately 30 days following last dose of OPN-6602
Primary	Number and type of treatment-emergent adverse events (TEAEs)		Through up to approximately 30 days following last dose of OPN-6602
Primary	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.	Through up to approximately 30 days following last dose of OPN-6602