← Back to Search

Monoclonal Antibodies

AMG 794 for Solid Cancers

Phase 1

Waitlist Available

Research Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Main study: 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

Main study: ECOG performance status of 0 to 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trialtests a new medicine to see if it's safe and effective. It will find the best dose to use.

Who is the study for?

Adults with certain advanced or metastatic solid tumors expressing CLDN6, such as lung, ovarian, and other cancers. They must have an ECOG performance status of 0-1 (fully active to restricted in physically strenuous activity), a life expectancy over 3 months, adequate organ function, and no suitable standard treatments left.Check my eligibility

What is being tested?

The trial is testing the safety and optimal dosing of AMG 794 for patients with CLDN6-positive tumors. It aims to find the highest dose that can be given without causing severe side effects.See study design

What are the potential side effects?

Specific side effects are not listed but generally may include reactions at the infusion site, fatigue, nausea, changes in blood counts or chemistry reflecting organ function which will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have a tumor larger than 10mm that hasn't been biopsied in the last 3 months.

Select...

I can perform all my usual activities without assistance.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

My cancer expresses CLDN6 and is advanced or has spread.

Select...

I am 18 years old or older.

Select...

I am 18 years old or older.

Select...

My cancer is advanced, cannot be surgically removed, and has no standard treatments left.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

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

Number of Participants Who Experience a Treatment-related AE

Secondary outcome measures

1-year Overall Survival (OS)

2-year OS

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

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part 2: AMG 794 Monotherapy Dose ExpansionExperimental Treatment1 Intervention

Participants with CLDN6-positive advanced/metastatic NSCLC, EOC, or other solid tumor indications will be treated with the OBD of AMG 794 identified in Part 1.

Group II: Part 1: AMG 794 Monotherapy Dose ExplorationExperimental Treatment1 Intervention

Participants with claudin 6 (CLDN6)-positive advanced/metastatic non-squamous non-small cell lung cancer (NSCLC), epithelial ovarian cancer (EOC), or other solid tumor indications will be treated in up to 11 multiple ascending cohorts with additional participants optionally enrolled in dose exploration cohorts with target dose levels that have previously been shown to be safe and tolerable.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor

1,370 Previous Clinical Trials

1,377,730 Total Patients Enrolled

14 Trials studying Ovarian Cancer

6,227 Patients Enrolled for Ovarian Cancer

MDStudy DirectorAmgen

913 Previous Clinical Trials

924,173 Total Patients Enrolled

13 Trials studying Ovarian Cancer

6,287 Patients Enrolled for Ovarian Cancer

Media Library

AMG 794 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05317078 — Phase 1

Ovarian Cancer Research Study Groups: Part 1: AMG 794 Monotherapy Dose Exploration, Part 2: AMG 794 Monotherapy Dose Expansion

Ovarian Cancer Clinical Trial 2023: AMG 794 Highlights & Side Effects. Trial Name: NCT05317078 — Phase 1

AMG 794 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05317078 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the AMG 794 Monotherapy Dose Exploration obtained FDA clearance?

"Our assessment of AMG 794 Monotherapy Dose Exploration's safety was a 1, as it is currently undergoing Phase 1 trials and the available data on its efficacy and safety are limited."

Answered by AI

Are there any openings at this time for prospective participants?

"Data hosted on clinicaltrials.gov reveals that recruitment for this trial has ceased. It was first posted in February of 2023, and last updated 25 days later; however, 2341 other studies are still currently recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05317078.