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Trial Title:
Study to Assess Safety and Tolerability of OPN-6602 in Subjects with Relapsed And/or Refractory Multiple Myeloma
NCT ID:
NCT06433947
Condition:
Relapsed Multiple Myeloma
Refractory Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Dexamethasone
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
OPN-6602
Description:
orally active, small molecule inhibitor of EP300 and CBP bromodomain; dosed daily
Arm group label:
Dose escalation in combo with dexamethasone
Arm group label:
Dose escalation monotherapy
Arm group label:
Dose expansion
Intervention type:
Drug
Intervention name:
Dexamethasone
Description:
Synthetic glucocorticoid; 40 mg Days 1, 8, 15 of each cycle
Arm group label:
Dose escalation in combo with dexamethasone
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Banner MD Anderson
Address:
City:
Gilbert
Zip:
85234
Country:
United States
Status:
Recruiting
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Karmanos Cancer Institute
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Facility:
Name:
START Midwest
Address:
City:
Grand Rapids
Zip:
49546
Country:
United States
Status:
Recruiting
Facility:
Name:
Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Start date:
August 22, 2024
Completion date:
July 2026
Lead sponsor:
Agency:
Opna Bio LLC
Agency class:
Industry
Source:
Opna Bio LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06433947
