Dose Escalation Study of Teclistamab, a Humanized BCMA*CD3 Bispecific Antibody, in Participants With Relapsed or Refractory Multiple Myeloma

Active:	Yes
Cancer Type:	Multiple Myeloma	NCT ID:	NCT03145181
Trial Phases:	Phase I	Protocol IDs:	CR108206 (primary) NCI-2017-01157 64007957MMY1001 2016-002122-36
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Janssen Research & Development, LLC
NCI Full Details:	http://clinicaltrials.gov/show/NCT03145181

Summary

The purpose of this study is to identify the recommended Phase 2 dose(s) (RP2Ds) and schedule
assessed to be safe for Teclistamab and to characterize the safety and tolerability of
Teclistamab at the RP2Ds.

Objectives

The study will be conducted in 2 parts, separately for IV and SC administration: dose
escalation (Part 1) and dose expansion (Part 2). It will evaluate safety, tolerability,
pharmacokinetics and preliminary antitumor activity of Teclistamab administered to adult
participants with relapsed or refractory multiple myeloma. The overall safety of the study
drug will be assessed by physical examinations, Eastern Cooperative Oncology Group
performance status, laboratory tests, vital signs, electrocardiograms, adverse event
monitoring, and concomitant medication usage. Disease evaluations will include peripheral
blood and bone marrow assessments at screening (performed within 28 days) and to confirm
stringent complete response (sCR), complete response (CR), or relapse from CR. The end of
study (study completion) is defined as 2 years after the last participant in Part 3 has
received his or her initial dose of teclistamab. Study record NCT04557098 is Phase 2 part of
this study and study record NCT03145181 is Phase 1 part of this study.

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