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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial tests two experimental drugs, AMG 994 and AMG 404, in patients with advanced cancer. The goal is to find the safest dose and see how well patients can handle these treatments.
Eligible Conditions
- Advanced Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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Who is running the clinical trial?
AmgenLead Sponsor
1,428 Previous Clinical Trials
1,384,764 Total Patients Enrolled
MDStudy DirectorAmgen
968 Previous Clinical Trials
929,092 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:Research Study Groups:
This trial has the following groups:- Group 1: Part 2: Dose Expansion
- Group 2: Part 1b: Dose Exploration
- Group 3: Part 1c: Dose Exploration
- Group 4: Part 1a: Dose Exploration
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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