A Study of an MMSET Inhibitor in Patients with Relapsed and Refractory Multiple Myeloma

Launched by K36 THERAPEUTICS, INC. · Dec 13, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new medication designed to treat adults with relapsed or refractory multiple myeloma, a type of blood cancer that has not responded to previous treatments. The drug is a selective small molecule inhibitor that works by targeting a specific enzyme in the body to help prevent cancer cell growth. This study is currently recruiting participants who are at least 18 years old and have had multiple treatments for their myeloma, including specific therapies. Eligible participants must have measurable disease and have exhausted their treatment options, meaning their cancer has come back or has not improved despite therapy.

If you or someone you know is considering joining this trial, you can expect to receive the new medication and be closely monitored for any side effects or responses to the treatment. The trial aims to ensure the safety of the drug and understand its effects on patients with this challenging condition. It’s important to note that there are specific criteria for participation, including recent treatment history and overall health, so potential participants will be carefully evaluated before enrolling.

Gender

ALL

Eligibility criteria

• Key Inclusion Criteria for Dose-Expansion:
• • ≥ 18 years of age
• • ECOG score ≤ 1
• • Multiple myeloma (as per IMWG)
• • ≥ 3 prior lines of therapy, including a PI, an IMiD, and an anti-CD38 antibody
• • Patients must be refractory to their last prior therapy
• • Cohorts A1/A2: Patients must have exhausted available therapeutic options that are expected to provide a meaningful clinical benefit, either through disease relapse, treatment refractory disease, intolerance, or refusal of the therapy
• • t(4;14) confirmed by standard of care FISH testing
• * Measurable disease, including at least 1 of the following criteria:
• • Serum M protein ≥ 0.50 g/dL (by SPEP)
• • Serum IgA ≥ 0.50 g/dL (IgA myeloma patients)
• • Urine M protein ≥ 200 mg/24 h (by UPEP)
• • sFLC involved light chain ≥ 10 mg/dL (100 mg/L) (patients with abnormal sFLC ratio)
• • Bone marrow plasma cells ≥ 30% (if only criterion for measurability)
• • Agreement to enroll into the REMS program (Cohort D- pomalidomide cohort only)
• Key Exclusion Criteria for Dose-Expansion:
• * Treatment with the following therapies in the specified time period prior to first dose:
• • Carfilzomib in the immediate last prior line of therapy for patients enrolled in Cohorts C1 and C2
• • Pomalidomide in the immediate last prior line of therapy for patients enrolled in cohort D
• • Radiation, chemotherapy, immunotherapy, or any other anticancer therapy ≤ 2 weeks
• • Cellular therapies ≤ 8 weeks
• • Autologous transplant \< 100 days
• • Allogenic transplant ≤ 6 months, or \> 6 months with active GVHD
• • Major surgery ≤ 4 weeks
• • Current plasma cell leukemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, and skin changes) syndrome, solitary bone lesion or bone lesions as the only evidence for plasma cell dyscrasia, myelodysplastic syndrome or a myeloproliferative neoplasm or light chain amyloidosis
• • MM with extramedullary disease
• • Active CNS disease
• • Inadequate bone marrow function
• • Inadequate renal, hepatic, pulmonary, and cardiac function
• • Active, ongoing, or uncontrolled systemic viral, bacterial, or fungal infection. Permitted prophylactic medications, antimicrobials or antiretroviral therapies defined in protocol.
• • Use of acid reducing agents and strong inhibitors or inducers of CYP3A4 within 14 days or 5 half-lives prior to first dose
• • Strong CYP1A2 inhibitors for patients receiving pomalidomide (Cohort D)
• • Active malignancy not related to myeloma requiring therapy within \< 2 years prior to enrollment, or not in complete remission, with exceptions defined in protocol.