Modakafusp Alfa for Multiple Myeloma
(iinnovate-1 Trial)

Recruiting in Palo Alto (17 mi)

+130 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Millennium Pharmaceuticals, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial tests a new drug called modakafusp alfa, given alone or with dexamethasone, for patients whose multiple myeloma has returned or resisted other treatments. The study aims to find the safest and most effective dose while monitoring side effects and benefits. The drug works by specifically targeting cancer cells.

Eligibility Criteria

This trial is for adults with relapsed/refractory Multiple Myeloma who've had at least 3 prior treatments, including an IMiD and a PI. They must show disease progression needing further therapy and have measurable disease markers. Exclusions include hepatitis B or C infection, central nervous system MM involvement, certain other cancers within the last 3 years, or recent stem cell transplants.

Inclusion Criteria

My multiple myeloma is progressing and I need more treatment.

I have had at least 3 different treatments for myeloma.

I have measurable myeloma or symptoms, and I can care for myself.

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Exclusion Criteria

I had a stem cell transplant and no ongoing immune system treatment for graft disease.

I have a specific blood or bone marrow condition like POEMS syndrome or Waldenstrom macroglobulinemia.

I have recovered from previous myeloma treatments, except for some remaining nerve issues.

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Treatment Details

Interventions

Dexamethasone (Corticosteroid)
Modakafusp alfa (CAR T-cell Therapy)

Trial OverviewThe study tests Modakafusp alfa's safety and optimal dosing alone or with Dexamethasone in three parts: finding a safe dose without harmful side effects; assessing its effectiveness alone or with standard-dose Dexamethasone; determining the best dose considering risks and benefits. It's administered intravenously at two different doses.

Participant Groups

7Treatment groups

Experimental Treatment

Group I: Part 3 (Dose Extension): Modakafusp alfa 240 mgExperimental Treatment1 Intervention

Participants will receive modakafusp alfa 240 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.

Group II: Part 3 (Dose Extension): Modakafusp alfa 120 mgExperimental Treatment1 Intervention

Participants will receive modakafusp alfa 120 mg, infusion, IV, Q4W, for each 28-day treatment cycle until disease progression or treatment discontinuation.

Group III: Part 2 (Dose Expansion): Modakafusp alfa TBD + Dexamethasone 40 mgExperimental Treatment2 Interventions

Dose(s) for Phase 2 will be based on safety and tolerability results from the preceding Phase 1 dose escalation cohorts. Participants in Phase 2 cohorts will receive modakafusp alfa TBD as a single agent. Participants in at least 1 cohort will receive modakafusp alfa TBD and modakafusp alfa TBD and dexamethasone 40 mg, orally, once weekly of each 28-day treatment cycle until treatment discontinuation.

Group IV: Part 1 (Dose Escalation) Schedule D: Modakafusp alfa TBDExperimental Treatment1 Intervention

Modakafusp alfa TBD, infusion, IV, once every 4 weeks (Q4W) on Day 1 of each 28-day treatment cycle until treatment discontinuation. The starting dose will be decided by the investigators and sponsor representatives based on all available clinical information.

Group V: Part 1 (Dose Escalation) Schedule C: Modakafusp alfa TBDExperimental Treatment1 Intervention

Modakafusp alfa TBD, infusion, IV, once every 3 weeks (Q3W) on Day 1 of each 21-day treatment cycle until treatment discontinuation. The starting dose will be decided by the investigators and sponsor representatives based on all available clinical information.

Group VI: Part 1 (Dose Escalation) Schedule B: Modakafusp alfa TBDExperimental Treatment1 Intervention

Modakafusp alfa TBD, infusion, IV, once every 2 weeks (Q2W) on Days 1 and 15 of each 28-day treatment cycle until treatment discontinuation. The starting dose will be decided by the investigators and sponsor representatives based on all available clinical information.

Group VII: Part 1 (Dose Escalation) Schedule A: Modakafusp alfa 0.001 Up to 14 mg/kgExperimental Treatment1 Intervention

Modakafusp alfa 0.001 up to 14 milligram per kilogram (mg/kg), infusion, intravenously (IV), once every week (Q1W) on Days 1, 8, 15 and 22 of each 28-day treatment cycle up to 2 cycles, followed by once on Days 1 and 15 of each 28-day treatment cycle up to 4 cycles, followed by once on Day 1 of each 28-day treatment cycle until treatment discontinuation.