NCT04727554

Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors

A Phase 1, Multicenter, Open-label, Dose Exploration and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 994 Monotherapy and Combination of AMG 994 and AMG 404 in Subjects With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the safety, tolerability, and maximum tolerated dose (MTD)/maximum tolerated combination dose (MTCD) or recommended phase 2 dose (RP2D) of AMG 994 as monotherapy and AMG 994 in combination with AMG 404 in participants with advanced solid tumors.

Detailed description

AMG 994 will be administered by short term intravenous (IV) infusion once weekly in each 28-day cycle and AMG 404 will be administered by short-term IV infusion once every 4 weeks (Q4W) in a 28 day cycle (on day 1 of cycle 2 and beyond). The study will be conducted in 2 parts: Part 1 - Dose Exploration and Part 2 - Dose Expansion.

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
DRUG	AMG 994	Administered as an intravenous (IV) infusion.
DRUG	AMG 404	Administered as an intravenous (IV) infusion.

Timeline

• Start date: 2021-04-29
• Primary completion: 2023-06-05
• Completion: 2023-06-05
• First posted: 2021-01-27
• Last updated: 2025-01-06
• Results posted: 2025-01-06

Locations

17 sites across 10 countries: United States, Australia, Belgium, Canada, France, Germany, Japan, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study