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AMG 994 for Solid Tumors

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
Participant must have histologically or cytologically proven metastatic or locally advanced solid tumors of known MSLN expression who have relapsed after and/or are refractory to established and available therapies with known clinical benefit, for which: No standard systemic therapy exists; or Standard systemic therapy has failed or is not available.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 36 months
Awards & highlights

Study Summary

This trial is testing a new drug, AMG 994, to see if it is safe and effective for treating advanced solid tumors. The trial will also test AMG 994 in combination with another drug, AMG 404, to see if the combination is more effective than AMG 994 alone.

Eligible Conditions
  • Advanced Solid Tumors

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months 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 Clinically Significant Change from Baseline in Clinical Laboratory Tests
Number of Participants Who Experience a Clinically Significant Change from Baseline in Electrocardiogram (ECG) Results
Number of Participants Who Experience a Clinically Significant Change from Baseline in Vital Sign Measurements
+3 more
Secondary outcome measures
Area Under the Serum Concentration-time Curve (AUC) of AMG 404
Area Under the Serum Concentration-time Curve (AUC) of AMG 994
Duration of Response (DOR)
+11 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part 2: Dose ExpansionExperimental Treatment2 Interventions
Participants will be administered with the MTD or RP2D of AMG 994 identified in the dose escalation part of the study, in combination with AMG 404.
Group II: Part 1c: Dose ExplorationExperimental Treatment2 Interventions
Determine the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D) of AMG 994, in combination with AMG 404.
Group III: Part 1b: Dose ExplorationExperimental Treatment2 Interventions
Determine the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D) of AMG 994, in combination with AMG 404.
Group IV: Part 1a: Dose ExplorationExperimental Treatment2 Interventions
Determine the maximum tolerated dose (MTD) or the recommended phase 2 dose (RP2D) of AMG 994, in combination with AMG 404.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AMG 994
2021
Completed Phase 1
~20
AMG 404
2020
Completed Phase 1
~230

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,677 Total Patients Enrolled
MDStudy DirectorAmgen
913 Previous Clinical Trials
924,120 Total Patients Enrolled

Media Library

AMG 994 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04727554 — Phase 1
Solid Tumors Research Study Groups: Part 2: Dose Expansion, Part 1b: Dose Exploration, Part 1c: Dose Exploration, Part 1a: Dose Exploration
Solid Tumors Clinical Trial 2023: AMG 994 Highlights & Side Effects. Trial Name: NCT04727554 — Phase 1
AMG 994 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04727554 — Phase 1

Frequently Asked Questions

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

How many venues are responsible for overseeing the execution of this research trial?

"Patients are being recruited for this medical trial at the Princess Margaret Cancer Centre in Toronto, Sarah Cannon Research Institute in Nashville and Henry Ford Hospital/Henry Ford Health Systems in Detroit. Additionally, there are 5 other geographic locations involved."

Answered by AI

Can I join this research project?

"This trial is enrolling 11 qualified participants, aged 18 - 100 years old, who have advanced solid tumours. Aside from this general criteria, prospective candidates must be willing to submit a biopsy before and during their treatment with AMG 994; they must also sign an informed consent document prior to any study-specific activities/procedures. Eligible cancers include mesothelioma, pancreatic adenocarcinoma, MSLN positive NSCLC squamous cell carcinoma or adenocarcinoma and high grade serous ovarian carcinomas that are measurable or evaluable as per modified RECIST 1"

Answered by AI

Is AMG 994 dangerous to patients if administered correctly?

"The safety of AMG 994 is rated a 1 on the Power scale, due to this being an early-phase study with limited evidence related to its efficacy and security."

Answered by AI

Does this research experiment permit persons over 30 to participate?

"In keeping with the conditions of participation in this medical trial, applicants must be no younger than 18 and not exceed 100 years old."

Answered by AI

Are there any available slots for participants in this experiment?

"As per the clinicaltrials.gov portal, this trial is not currently accepting candidates; it was first posted on April 29th 2021 and most recently updated November 16th 2022. Nevertheless, there are presently 2502 other studies actively recruiting participants to join their trials."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors
2021. "Study of AMG 994 Monotherapy and AMG 994 and AMG 404 Combination Therapy in Participants With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04727554.
~3 spots leftby Apr 2025
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