A Study of Modakafusp Alfa on Adult Participants With Relapsed/Refractory Multiple Myeloma

Active:	No
Cancer Type:	Multiple Myeloma	NCT ID:	NCT03215030
Trial Phases:	Phase I Phase II	Protocol IDs:	TAK-573-1501 (primary) NCI-2017-01894 U1111-1195-8134 TV48573-ONC-10128
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Takeda
NCI Full Details:	http://clinicaltrials.gov/show/NCT03215030

Summary

The main aims of this 3-part study are as follows:

Part 1: To determine any side effects from modakafusp alfa single treatment and how often
they occur. The dose of modakafusp alfa will be increased a little at a time until the
highest dose that does not cause harmful side effects is found.

Part 2: To assess clinical activity of one or more dosing schedules of modakafusp alfa
alone in participants with relapsed/refractory multiple myeloma. Dexamethasone standard
dose will be administered with one or more selected dose of modakafusp alfa in selected
group of participants.

Part 3: To find the optimal dose with the more favorable risk-benefit profile of
modakafusp alfa.

Participants will receive modakafusp alfa at one of two doses which will be given through
a vein.

Objectives

The drug being tested in this study, and which will be given through a vein, is called
modakafusp alfa (TAK-573 ) as single agent or in combination with dexamethasone. The
study will determine the safety, tolerability, and efficacy of modakafusp alfa as single
agent and in combination with dexamethasone in participants with relapsed/refractory
multiple myeloma (RRMM). The study consists of 3 Parts:

Part 1: Dose Escalation, Part 2: Dose Expansion, Part 3: Dose Extension

The study will enroll approximately 65 participants in Part 1, 35 in Part 2, and 236 in
Part 3. Participants will be assigned to one of the following treatment groups in Parts 1
and 2 of the study. Participants will be randomly assigned in Part 3 of the study as
given below:

- Part 1 (Dose Escalation) Schedule A: Modakafusp alfa 0.001 Up to 14 mg/kg

- Part 1 (Dose Escalation) Schedule B: Modakafusp alfa TBD

- Part 1 (Dose Escalation) Schedule C: Modakafusp alfa TBD

- Part 1 (Dose Escalation) Schedule D: Modakafusp alfa TBD

- Part 2 (Dose Expansion): Modakafusp alfa TBD + Dexamethasone 40 mg

- Part 3 (Dose Extension): Modakafusp alfa 120 mg

- Part 3 (Dose Extension): Modakafusp alfa 240 mg

The Part 1 (Dose Escalation) portion of the study will follow a 3+3 dose escalation
design to evaluate once-weekly up to 4 different schedules of administration of
modakafusp alfa starting at 0.001 mg/kg for dose limiting toxicity (DLT) evaluation and
to determine the maximum tolerated dose (MTD) or an optimal biological dose (OBD) for
assessments in Part 2.

The Part 2 (Dose Expansion) will further assess the safety profile of modakafusp alfa and
its efficacy at MTD or OBD.

For Part 3 (Dose Extension) participants will be randomized 1:1 to receive single-agent
modakafusp alfa 120 mg or 240 mg Q4W.

Parts 1 and 2 will be conducted at multiple centers in the United States. Part 3 will be
conducted worldwide. The maximum treatment duration in this study is up to 12 months
(Parts 1 and 2) or until disease progression (Part 3) and overall time to participate in
the study is approximately up to 90 months. Participants with clinical benefit may
continue treatment after sponsor approval.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.