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

Cancer Categories

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objective (Monotherapy Escalation):

To characterize the safety and tolerability of OPN-6602 in order to identify the RP2D

Secondary Objectives (Monotherapy Escalation):

Primary Objective (Combination Escalation):

To characterize the safety and tolerability of OPN-6602 plus dexamethasone in order to identify the RP2D

Secondary Objectives (Combination Escalation):

Primary Objective (Expansion Monotherapy or Combination):

To evaluate preliminary antitumor activity of OPN-6602 when administered in combination with or without dexamethasone

Secondary Objectives (Expansion Monotherapy or Combination):

To further evaluate preliminary antitumor activity of OPN-6602 when administered in combination with or without dexamethasone
To evaluate the PK of OPN-6602 when administered in combination with or without Dexamethasone

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

Locations

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices