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RecruitingLast updated: 3 May 2024

AMG794: This study is evaluating how safe and tolerable a new drug (called AMG 794) is in adults with Claudin 6-positive advanced or metastatic non-small cell lung cancer, epithelial ovarian cancer, and other solid cancersPhase 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

Clinical summary

Summary

This study is recruiting people with locally advanced or metastatic malignant solid cancers expressing Claudin-6 (CLDN6) including but not limited to:

  • non-small cell lung cancer;
  • epithelial ovarian cancer;
  • testicular germ cell cancer;
  • uterine endometrial cancer; or
  • triple negative breast cancer.

The study is evaluating the safety and tolerability of a new drug (called AMG 794), and will also seek 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.

The study has two parts: Dose Exploration and Dose Expansion.

In Part 1 (Dose Exploration), eligible participants will be treated in up to 11 multiple ascending cohorts with additional participants optionally enrolled with target dose levels that have previously been shown to be safe and tolerable.

In Part 2 (Dose Expansion), eligible participants will be treated with the OBD of AMG 794 as identified in Part 1.

AMG 794 will be administered as a short-term intravenous (IV) infusion.

 

Conditions

This trial is treating patients with solid cancers including but not limited to: non-small cell lung cancer, epithelial ovarian cancer, testicular germ cell cancer, uterine endometrial cancer and triple negative breast cancer

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

AMG794

More information

Trial Identifiers

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Trial sponsor

Amgen

Scientific Title

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

Eligibility

Inclusion

  • 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, consent to provide archival or fresh tumor tissue slides for immunohistochemistry (IHC) assessment is sufficient and the enrolment is not dependent on availability of the CLDN6 expression test result.
  • 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

Main study:

  • Positive test for human immunodeficiency virus, hepatitis B or hepatitis C.
  • History of other malignancy within the past 2 years.
  • Participant with symptoms and/or clinical signs and/or radiographic signs that indicate an acute and/or uncontrolled active systemic infection with 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.
  • 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.
  • Female participants who are of childbearing potential unwilling to use protocol-specified method of contraception, who are breastfeeding and/or planning to become pregnant.
  • Male participants who have a female partner of childbearing potential who are unwilling to practice sexual abstinence or use protocol-specified contraception and/or who are unwilling to abstain from donating sperm.
  • 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.

Inclusion

  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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