Neoplasms, Advanced Solid Clinical Trial
Official title:
A Phase 1, Open-Label, Dose Escalation Study Evaluating the Safety, Tolerability and Pharmacokinetics of Trebananib (AMG 386) in Adult Japanese Patients With Advanced Solid Tumors
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetic (PK) profile of trebananib (AMG 386) after intravenous administration in adult Japanese participants with advanced solid tumors.
The drug being tested in this study is called trebananib (AMG 386). Trebananib (AMG 386) is
being tested to treat people with advanced solid tumors.
This study will look at the safety, tolerability and pharmacokinetic (PK) profile of
trebananib and response to treatment.
The study will enroll approximately 18 participants. Once enrolled, participants will be
assigned sequentially into 1 of the 3 cohorts:
- Trebananib 3 milligram/kilogram (mg/kg),
- Trebananib 10 mg/kg,
- Trebananib 30 mg/kg.
All participants will receive trebananib via 60 minute intravenous infusion. This study will
be conducted in Japan. The overall time to participate in this study is 14 weeks or more.
Participants will attend the end-of-treatment visit 28 days after the last dose of study
drug.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03708211 -
A Study to Assess the Relative Bioavailability, Effect of Food, and Gastric Potential Hydrogen (pH) Modification on the Pharmacokinetics (PK) of TAK-931 in Participants With Advanced Solid Tumors
|
Phase 1 |