Clinical trial NCT06433947: Study to Assess Safety and Tolerability of OPN-6602 in Subjects With Relapsed and/or Refractory Multiple Myeloma
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Relapsed Multiple Myeloma
Refractory Multiple Myeloma
Lead sponsor: Opna Bio LLC
Sponsor class: INDUSTRY
First posted: 2024-05-30
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Number and type of dose-limiting toxicities (DLTs)
timeFrame: Through up to approximately 30 days following last dose of OPN-6602
measure: Number and type of treatment-emergent adverse events (TEAEs)
timeFrame: Through up to approximately 30 days following last dose of OPN-6602
measure: Number of Participants With Clinical Laboratory Test Abnormalities
timeFrame: Through up to approximately 30 days following last dose of OPN-6602
Secondary outcomes:
Other outcomes:
Locations:
city: Gilbert
country: United States
facility: Banner MD Anderson
state: Arizona
city: Stanford
country: United States
facility: Stanford Cancer Institute
state: California
city: Atlanta
country: United States
facility: Emory Winchip Cancer Center
state: Georgia
city: Westwood
country: United States
facility: University of Kansas Clinical Research Center
state: Kansas
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Grand Rapids
country: United States
facility: START Midwest
state: Michigan
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Salt Lake City
country: United States
facility: Huntsman Cancer Center Institute University of Utah
state: Utah
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Center
state: Washington
Study officials:
References: