C4 Therapeutics has dosed the first patient in its Phase II MOMENTUM trial of cemsidomide, an oral ikaros family zinc finger protein 1/3 (IKZF1/3) degrader, combined with dexamethasone for patients with relapsed or refractory multiple myeloma (RRMM).
The trial will assess this combination in a population with limited treatment options, specifically using the recommended 100 µg dose established in previous studies.
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This single-arm, multi-centre, open-label Phase II study is designed to evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics of cemsidomide plus dexamethasone in patients who have received at least three prior anti-myeloma regimens.
Eligible patients must have previously been treated with an IKZF1/3 degrader, a proteasome inhibitor, an anti- cluster of differentiation 38 (cd38) antibody, and either a T-cell engager or chimeric antigen receptor T-cell (CAR-T) therapy.
The primary endpoint is overall response rate according to International Myeloma Working Group criteria evaluated by independent review.
The study will enrol around 100 participants. Cemsidomide will be administered daily for 14 days on, 14 days off alongside weekly dexamethasone. Secondary endpoints will address additional efficacy and safety outcomes.
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By GlobalDataC4 Therapeutics’ broader cemsidomide development includes a planned Phase Ib study combining cemsidomide with elranatamab, an FDA-approved CD3-targeted bispecific antibody.
Key milestones include Phase Ib initiation in Q2 2026, further analysis of Phase I data in mid-2026, and completion of the current trial’s enrolment by Q1 2027.
C4 Therapeutics chief medical officer Len Reyno said: “Initiating the Phase II MOMENTUM trial, which builds upon the compelling anti-myeloma activity and differentiated safety profile established in the Phase I trial, is a critical step for cemsidomide to become a foundational therapy for multiple myeloma patients, who are in need of a safe, oral, and convenient treatment option.
“With this milestone accomplished, we are also on track to initiate the Phase Ib trial of cemsidomide in combination with elranatamab in the second quarter, as we continue to advance our regulatory strategy that could deliver two accelerated approval paths in multiple myeloma.”
