A Safety, Tolerability, and Pharmacokinetics Study of AMG 794 With Claudin 6-positive Non-squamous Non-small Cell Lung Cancer or Epithelial Ovarian Cancer.

• Status: Not yet recruiting
• Trial end date: 2026-05-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen

Criteria

Inclusion Criteria:

Pre-screening:

• Age ≥ 18 years.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 -1.

• Participants with histologically or cytologically documented non-squamous NSCLC or EOC that is metastatic or unresectable.

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 non-squamous NSCLC or EOC that is metastatic or unresectable at screening time point. Participants should have exhausted available standard of care systemic therapy or should not be candidates for such available therapy.

• Available positive test result for claudin 6 expression resulting from testing of an available archival tissue sample in pre-screening or obtained from biopsy in a screening procedure.

• For dose expansion cohorts: Participants with at least 1 measurable lesion ≥ 10mm which has not undergone biopsy within 3 months of screening scan. This lesion cannot be biopsied at any time during the study.

• Life expectancy > 3 months.

• Adequate organ functions.

Exclusion Criteria:

Main study:

• Positive test for human immunodeficiency virus, hepatitis B or hepatitis C.

• History of other malignancy within the past 2 years.

• Ongoing or active infection requiring IV anti-infective therapy less than 1 week prior to administration of a first dose of study treatment.

• Evidence of new or growing central nervous system metastases, leptomeningeal disease, or spinal cord compression. Participants with known brain metastases may be eligible if they completed radiotherapy, surgery or stereotactic surgery for the brain metastases and do not present with neurological symptoms and/or have stable disease assessed by imaging within 4 weeks of signing consent to this study and not requiring acute corticosteroid therapy or steroid taper.

• History or evidence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection unless agreed upon with Medical Monitor and meeting the following criteria:

• Negative test for SARS-CoV-2 ribonucleic acid by reverse transcriptase-polymerase chain reaction within 72 hours of first dose of investigational product (IP).

• No acute symptoms of coronavirus (COVID-19) disease within 10 days prior to first dose of IP (counted from day of positive test for asymptomatic participants).

• Currently receiving treatment in another investigational device or drug study, or less than 4 weeks since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded.

• Anticancer therapies including radiotherapy, chemotherapy or molecularly targeted treatments or tyrosine kinase inhibitors within 2 weeks or 5 half-lives (whichever is longer) of administration of a first dose of study treatment; immunotherapies/monoclonal antibodies within 3 weeks of administration of a first dose of study treatment.

• Has had a major surgery within 4 weeks of administration of a first dose of study treatment (excluded: biopsies and central venous catheter insertion).

• Autoimmune disorders requiring chronic systemic steroid therapy or any other form of immunosuppressive therapy while on study, (e.g., ulcerative colitis, Crohn's disease). Recent or current use of inhaled steroids or physiological substitution in case of adrenal insufficiency is not exclusionary.

• Pregnancy and contraception.

• Participant has known sensitivity to any of the products or components to be administered during dosing.

• Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures (e.g., Clinical Outcome Assessments) to the best of the participant and investigator's knowledge.

• History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to participant safety or interfere with the study evaluation, procedures or completion.