Trials / Active Not Recruiting
Active Not RecruitingNCT05322577
A Study Evaluating Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer.
A Phase 1b/2 Study Evaluating the Safety, Tolerability, Efficacy, and Pharmacokinetics of Bemarituzumab in Combination With Other Anti-cancer Therapies in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer (FORTITUDE-103).
- Status
- Active Not Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 72 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years – 100 Years
- Healthy volunteers
- Not accepted
Summary
The main objectives of this study are to evaluate the safety and tolerability of bemarituzumab in combination with other anti-cancer therapies, and to evaluate the efficacy of bemarituzumab in combination with S-1 and oxaliplatin (SOX) and nivolumab as assessed by objective response.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Bemarituzumab | Intravenous (IV) infusion |
| DRUG | CAPOX | CAPOX administered as a combination of oxaliplatin as an IV infusion and capecitabine orally as tablets. |
| DRUG | SOX | SOX administered as a combination of oxaliplatin as an IV infusion and S-1 orally. |
| DRUG | Nivolumab | IV infusion. |
Timeline
- Start date
- 2022-05-17
- Primary completion
- 2025-11-21
- Completion
- 2026-08-12
- First posted
- 2022-04-12
- Last updated
- 2025-12-05
Locations
42 sites across 5 countries: United States, Japan, Singapore, South Korea, Taiwan
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05322577. Inclusion in this directory is not an endorsement.