Clinical Trial: NCT06131398
A Study of AMG 355 Alone and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors
Status:
COMPLETEDPhase:
Phase 1| Lead Sponsor: | Amgen |
| Information Provided By: | Amgen |
| Last Update Posted: | 2026-08-11 |
Study Overview
Brief Summary
The primary objectives of this study are to:
- Evaluate the safety and tolerability of AMG 355 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors
- Determine the recommended phase 2 dose and the maximum tolerated dose for AMG 355 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors.
Official Title
A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 355 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Conditions
Advanced Solid Tumors
Intervention / Treatment
- Drug: AMG 355
- Drug: Pembrolizumab
Other Study ID Numbers
- 20220028
Start Date (Actual)
2024-03-07
Primary Completion Date (Actual)
2026-07-22
Study Completion Date (Actual)
2026-07-22
Enrollment (Actual)
77
Study Type
Interventional
Phase
Phase 1
| Lead Sponsor: | Amgen |
| Information Provided By: | Amgen |
| Last Update Posted: | 2026-08-11 |
Study Overview
Brief Summary
The primary objectives of this study are to:
- Evaluate the safety and tolerability of AMG 355 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors
- Determine the recommended phase 2 dose and the maximum tolerated dose for AMG 355 as monotherapy and in combination with pembrolizumab in participants with advanced solid tumors.
Official Title
A Phase 1 First-in-Human Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of AMG 355 as Monotherapy and in Combination With Pembrolizumab in Subjects With Advanced Solid Tumors
Conditions
Advanced Solid Tumors
Intervention / Treatment
- Drug: AMG 355
- Drug: Pembrolizumab
Other Study ID Numbers
- 20220028
Start Date (Actual)
2024-03-07
Primary Completion Date (Actual)
2026-07-22
Study Completion Date (Actual)
2026-07-22
Enrollment (Actual)
77
Study Type
Interventional
Phase
Phase 1