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Non-squamous Non-small Cell Lung CancerPhase 1NCT05317078

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

A Phase 1 study testing AMG 794 in people with Non-squamous Non-small Cell Lung Cancer and Epithelial Ovarian Cancer, run by Amgen at 8 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AMG 794
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
8 sitesin 3 countries
Study dates
28 Feb 2023to 1 Apr 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

8 sites in 3 countries.

8 sites in 3 countries

United States4 sites

  • City of Hope National Medical Center

    Duarte, California, 91010

  • University of California Los Angeles

    Los Angeles, California, 90095-1678

  • University of California Irvine

    Orange, California, 92868

  • Virginia Commonwealth University

    Richmond, Virginia, 23219

Other trials in United States

Australia3 sites

  • Southern Oncology Clinical Research Unit

    Bedford Park, South Australia, 5042

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • Cabrini Hospital

    Malvern, Victoria, 3144

Other trials in Australia

Switzerland1 site

  • Inselspital Bern

    Bern, 3010

Other trials in Switzerland

About this study

Official 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

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.

Being tested
AMG 794
Keywords
Malignant solid tumors, Claudin 6-positive, AMG 794, CLDN6
Medical subject headings
Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AMG 794Drug

    Short-term intravenous (IV) infusion.

Study groups in NCT05317078
Study groupRoleWhat they receive
Cohort 1: AMG 794ExperimentalParticipants were planned to receive the lowest dose (Dose A), as a short-term IV infusion on Cycle 1 Day 1, with an increased dose on Cycle 1 Day 3 (Dose C) and Cycle 1 Day 8 (Dose E). After reaching the highest planned dose for the cohort (Dose E), participants continued to receive short-term IV infusions on Cycle 1 Day 15, then QW thereafter in 28-day cycles. Due to early study termination, participants only received Dose A on Cycle 1 Day 1 and Dose C on Cycle 1 Day 3.
Receives: Drug: AMG 794
Cohort 1a: AMG 794ExperimentalParticipants were planned to receive the lowest dose (Dose A), as a short-term IV infusion on Cycle 1 Day 1, with an increased dose on Cycle 1 Day 8 (Dose B) and Cycle 1 Day 15 (Dose D). After reaching the highest planned dose for the cohort (Dose D), participants continued to receive short-term IV infusions QW thereafter in 28-day cycles.
Receives: Drug: AMG 794

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Experience a Dose Limiting Toxicity (DLT)

    Measured: Day 1 to Day 28

  2. Number of Participants Who Experience a Treatment-emergent Adverse Event (TEAE)

    Adverse events (AEs) are defined as any untoward medical occurrence in a clinical study participant irrespective of a causal relationship with the study treatment. TEAEs are any event that occurs after the participant has received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occur after study treatment administration will be recorded as TEAEs.

    Measured: Day 1 to a maximum of 2 years

  3. Number of Participants Who Experience a Treatment-related AE

    Measured: Day 1 to a maximum of 2 years

Secondary outcomes (12)

  1. Minimum Efficacious Dose (MED)

    Defined as the first unconfirmed partial response (PR) or better.

    Measured: Day 1 to a maximum of 2 years

  2. Maximum Observed Serum Concentration (Cmax) of AMG 794

    Measured: Cycle 1 Day 1 to Cycle 6 Day 1 (28 day cycle length)

  3. Minimum Observed Serum Concentration (Cmin) of AMG 794

    Measured: Cycle 1 Day 1 to Cycle 6 Day 1 (28 day cycle length)

  4. Area Under the Concentration-time Curve (AUC) Over the Dosing Interval of AMG 794

    Measured: Cycle 1 Day 1 to Cycle 6 Day 1 (28 day cycle length)

  5. Confirmed objective response (OR)

    Defined as best overall response [BOR] of complete response [CR] or PR based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1).

    Measured: Day 1 to a maximum of 2 years

  6. Confirmed OR

    Defined as immune BOR (iBOR) of immune CR (iCR) or immune PR (iPR) based on Immune RECIST (iRECIST).

    Measured: Day 1 to a maximum of 2 years

  7. Cancer Antigen (CA) 125 Response

    CA 125 response will be analyzed in the Ovarian Cancer Analysis Set, defined as all participants with a primary tumor type of ovarian cancer who are enrolled and receive at least 1 dose of AMG 794.

    Measured: Day 1 to a maximum of 2 years

  8. Duration of Response

    Defined as the time from the first documentation of OR until the first documentation of disease progression or death due to any cause, whichever occurs first.

    Measured: Day 1 to a maximum of 2 years

  9. Time to Progression

    Defined as the time from enrollment until the first documentation of radiological disease progression.

    Measured: Day 1 to a maximum of 2 years

  10. Progression-free Survival (PFS)

    Defined as the time from enrollment until the first documentation of radiologic disease progression or death due to any cause, whichever occurs first.

    Measured: Day 1 to a maximum of 2 years

  11. 1-year Overall Survival (OS)

    Measured: 1 year

  12. 2-year OS

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2022
  2. Study start28 Feb 2023
  3. Primary completion19 Dec 2023
  4. Study completion1 Apr 2024

Why it stopped: Sponsor strategic decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05317078
Sponsor's protocol ID
20210007
Status last verified
Oct 2025
First submitted
30 Mar 2022
Last updated
8 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AMG 794 in people with Non-squamous Non-small Cell Lung Cancer and Epithelial Ovarian Cancer, run by Amgen at 8 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States, Australia, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor strategic decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experience a Dose Limiting Toxicity (DLT) (time frame: Day 1 to Day 28). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05317078.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2025.

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