Trials / Active Not Recruiting
Active Not RecruitingNCT03399799
Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma
A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 279 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to characterize the safety of Talquetamab and to determine the recommended Phase 2 dose(s) (RP2Ds) and dosing schedule assessed to be safe for Talquetamab (Part 1 \[Dose Escalation\]) and to further characterize the safety of Talquetamab at the recommended Phase 2 dose(s) (RP2Ds) (Part 2 \[Dose Expansion\]).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Talquetamab | Participants will receive IV infusion or SC injection of Talquetamab. |
Timeline
- Start date
- 2017-12-16
- Primary completion
- 2022-07-07
- Completion
- 2027-10-20
- First posted
- 2018-01-16
- Last updated
- 2026-04-13
Locations
13 sites across 4 countries: United States, Belgium, Netherlands, Spain
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03399799. Inclusion in this directory is not an endorsement.