Trials / Terminated
TerminatedNCT05317078
A Phase 1 Safety, Tolerability, and Pharmacokinetics Study of AMG 794 With Claudin 6-positive Non-small Cell Lung Cancer, Epithelial Ovarian Cancer, and Other Malignant Solid Tumor Indications
Phase 1 First-In-Human Study to Explore the Safety, Tolerability, and Pharmacokinetics of AMG 794 in Participants With Claudin 6-positive Advanced/Metastatic Non-small Cell Lung Cancer, Epithelial Ovarian Cancer, and Other Malignant Solid Tumor Indications
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- Amgen · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to evaluate the safety and tolerability of AMG 794 in adult participants and to determine the optimal biological active dose (OBD), at or below the maximum tolerated dose (MTD) with MTD 1 as the maximum tolerated starting dose and MTD 2 as the maximum tolerated target dose.
Conditions
- Non-squamous Non-small Cell Lung Cancer
- Epithelial Ovarian Cancer
- Claudin 6-positive Advanced/Metastatic Malignant Solid Tumors
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AMG 794 | Short-term intravenous (IV) infusion. |
Timeline
- Start date
- 2023-02-28
- Primary completion
- 2023-12-19
- Completion
- 2024-04-01
- First posted
- 2022-04-07
- Last updated
- 2025-10-08
Locations
8 sites across 3 countries: United States, Australia, Switzerland
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05317078. Inclusion in this directory is not an endorsement.