Trials / Active Not Recruiting
Active Not RecruitingNCT04606381
A Study of Amivantamab Subcutaneous (SC) Administration for the Treatment of Advanced Solid Malignancies
An Open-label, Multicenter, Dose Escalation Phase 1b Study to Assess the Safety and Pharmacokinetics of Subcutaneous Delivery of Amivantamab, a Human Bispecific EGFR and cMet Antibody for the Treatment of Advanced Solid Malignancies
- Status
- Active Not Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 158 (actual)
- Sponsor
- Janssen Research & Development, LLC · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the feasibility of subcutaneous (SC) administration of amivantamab based on safety and pharmacokinetics and determine a dose, dose regimen and formulation for amivantamab SC delivery.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ami-LC-MD | Participants will receive amivantamab admixed with rHuPH20 SC infusion. |
| DRUG | Ami-LC | Participants will receive amivantamab SC infusion. |
| DRUG | Ami-HC | Participants will receive amivantamab SC infusion. |
| DRUG | Ami-HC-CF | Participants will receive amivantamab co-formulated with rHuPH20 as SC injection. |
Timeline
- Start date
- 2020-11-10
- Primary completion
- 2024-07-11
- Completion
- 2027-04-01
- First posted
- 2020-10-28
- Last updated
- 2026-04-13
Locations
12 sites across 4 countries: United States, Canada, South Korea, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04606381. Inclusion in this directory is not an endorsement.