A Phase 1 Safety, Tolerability, and Pharmacokinetics Study of AMG 794 With Claudin 6-positive Non… (NCT05317078) | Clinical Trial Compass
TerminatedPhase 1
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
Stopped: Sponsor strategic decision
United States, Australia3 participantsStarted 2023-02-28
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
Pre-screening:
* Age ≥ 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 -1.
* Participants with histologically or cytologically documented malignant solid tumor diseases expressing claudin-6 (CLDN6) including but not limited to NSCLC, EOC, testicular germ cell cancer, uterine endometrial cancer, or triple negative breast cancer, and the cancer is at least either locally advanced or metastatic at pre-screening.
* Participant has provided informed consent prior to initiation of any study specific activities/procedures.
Main study:
* Age ≥ 18 years.
* Participant has provided informed consent prior to initiation of any study specific activities/procedures.
* ECOG performance status of 0 to 1.
* Participants with histologically or cytologically documented malignant solid tumor diseases expressing CLDN6 including but not limited to NSCLC, EOC, testicular germ cell cancer, uterine endometrial cancer, or triple negative breast cancer, that is metastatic or unresectable at screening time point. Participants should have exhausted available SOC systemic therapy or should not be candidates for such available therapy.
* For participants enrolling in cohort 3 or higher dose cohort, available positive test result for CLDN6 expression resulting from testing of an available archival tissue sample in pre-screening or obtained from biopsy in a screening procedure. For participants enrolling in cohorts 1, 1a, or 2 during dose escalation, cons…
What they're measuring
1
Number of Participants Who Experience a Dose Limiting Toxicity (DLT)
Timeframe: Day 1 to Day 28
2
Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)
Timeframe: Day 1 to a maximum of 2 years
3
Number of Participants Who Experience a Treatment-related AE