Modakafusp Alfa + Daratumumab for Multiple Myeloma
(iinnovate-3 Trial)

Recruiting in Palo Alto (17 mi)

+41 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Takeda

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The main aim of this study is to determine safety and tolerability of modakafusp alfa given together with daratumumab to find out the best treatment dose. Another aim of this study is to learn more about the characteristics of modakafusp alfa.

Research Team

Study Director

Principal Investigator

Takeda

Eligibility Criteria

Adults with relapsed or refractory multiple myeloma who have tried at least three prior therapies, including specific inhibitors and antibodies, can join this trial. They must show disease progression after the last treatment but had some positive response to previous therapy. Good physical condition is required (ECOG 0-2), and they should not have severe heart issues, certain viral infections, or require high-dose steroids.

Inclusion Criteria

I've had at least 3 treatments including a PI, an IMiD, and an anti-CD38 drug, or my condition didn't improve with these treatments.

Participants in Phase 2a Dose Finding must have received 1 to 3 previous treatments for myeloma, but must not have responded well to lenalidomide. They should also not have become resistant to anti-CD38 mAb treatment. Additionally, they must have shown disease progression after their last treatment and have a good performance status.

I have been diagnosed with multiple myeloma.

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Exclusion Criteria

I have a serious heart condition, such as heart failure or uncontrolled high blood pressure.

I need to take more than 10mg of steroids daily for a chronic condition, not including my multiple myeloma treatment.

I have previously been treated with modakafusp alfa.

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Treatment Details

Interventions

Daratumumab (Immunotherapy)
Modakafusp Alfa (Immunotherapy)

Trial OverviewThe study tests Modakafusp Alfa combined with Daratumumab in adults with multiple myeloma to find a safe dosage and understand Modakafusp Alfa's properties. The trial has two phases: one for determining the best dose and another for further evaluation of that dose.

Participant Groups

3Treatment groups

Experimental Treatment

Group I: Phase 2a Dose Finding: Modakafusp Alfa (DL2) + DaratumumabExperimental Treatment2 Interventions

Modakafusp alfa at dose level 2 (DL2) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.

Group II: Phase 2a Dose Finding: Modakafusp Alfa (DL1) + DaratumumabExperimental Treatment2 Interventions

Modakafusp alfa at dose level 1 (DL1) \[selected from Phase 1 Dose Escalation\] with daratumumab SC 1800 mg, SC, QW in Cycles 1 and 2, Q2W in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.

Group III: Phase 1 Dose EscalationExperimental Treatment2 Interventions

Modakafusp alfa 60 to 240 mg, infusion, intravenously, once every 4 weeks (Q4W) with daratumumab 1800 mg, subcutaneously (SC), once weekly (QW) in Cycles 1 and 2, twice weekly (Q2W) in Cycles 3 to 6, and Q4W thereafter in each 28-day treatment cycle until disease progression.

Daratumumab is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Darzalex for:

Relapsed and refractory multiple myeloma
Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone

🇺🇸 Approved in United States as Darzalex for:

Multiple myeloma in patients who have received at least three prior therapies
Newly diagnosed multiple myeloma in combination with bortezomib, melphalan, and prednisone
Relapsed or refractory multiple myeloma in combination with lenalidomide and dexamethasone