Conditions: Neoplasms, Advanced Solid
Keywords: Drug Therapy
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 18
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Trebananib (AMG 386) 3 milligram/kilogram (mg/kg), 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks). arm 2: Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks). arm 3: Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).

Interventions: intervention 1: Trebananib 3 mg/kg intervention 2: Trebananib 10 mg/kg intervention 3: Trebananib 30 mg/kg
Intervention descriptions: intervention 1: Trebananib (AMG 386) 3 mg/kg, intravenous infusion. intervention 2: Trebananib (AMG 386) 10 mg/kg, intravenous infusion. intervention 3: Trebananib (AMG 386) 30 mg/kg, intravenous infusion.

Protocol document: