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Monoclonal Antibodies

AMG 193 + IDE397 for Solid Cancers

Phase 1 & 2
Recruiting
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
MTAP-null or lost MTAP expression solid tumor for which no standard therapy exists
MTAP-null or lost MTAP expression NSCLC with progression after 1 to 2 prior lines of systemic therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 pre-dose up to cycle 5 (cycle= 21 days)
Awards & highlights

Study Summary

This trial tests the safety and effectiveness of two drugs for treating advanced MTAP-null tumors, incl. NSCLC.

Who is the study for?
This trial is for adults with advanced solid tumors that can't be cured and have lost MTAP protein function. They should have tried up to two treatments for non-small cell lung cancer (NSCLC) without success, be able to swallow pills, and not have had certain bowel or heart issues recently. People who've taken MAT2A or PRMT5 inhibitors or strong drug modifiers can't join.Check my eligibility
What is being tested?
The study tests the safety and ideal dose of a new treatment combo: AMG 193 with IDE397 in patients whose tumors lack MTAP protein. It's also looking at how well this combination works against advanced NSCLC that has spread or cannot be removed by surgery.See study design
What are the potential side effects?
Possible side effects include typical reactions related to the immune system's response to the drugs, digestive disturbances due to oral medication intake, as well as any organ-specific issues arising from the novel mechanism of action these drugs employ.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer lacks MTAP and has no standard treatment available.
Select...
My NSCLC lacks MTAP and has worsened after 1-2 treatments.
Select...
My cancer has spread and cannot be cured with surgery or radiation.
Select...
My tests show I have a specific genetic change (MTAP loss).
Select...
I can swallow pills and will track my medication intake.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 pre-dose up to cycle 5 (cycle= 21 days)
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 pre-dose up to cycle 5 (cycle= 21 days) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Number of Participants Experiencing Dose Limiting Toxicities (DLTs)
Part 1: Number of Participants Experiencing Serious Adverse Events (SAEs)
Part 1: Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
+1 more
Secondary outcome measures
Part 1 and 2: Cmax of IDE397
Part 1 and 2: Maximal Plasma Concentration (Cmax) of AMG 193
Part 1 and 2: Time to Achieve Maximal Plasma Concentration (Tmax) of AMG 193
+15 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Part 2: Dose Expansion of AMG 193 Combined With IDE397Experimental Treatment2 Interventions
AMG 193 and IDE397 will be administered PO in cycles of 21 days.
Group II: Part 1: Dose Exploration of AMG 193 Combined With IDE397Experimental Treatment2 Interventions
Participants will receive escalating doses of AMG 193 and IDE397 administered orally (PO) in cycles of 21 days.

Find a Location

Who is running the clinical trial?

AmgenLead Sponsor
1,374 Previous Clinical Trials
1,378,789 Total Patients Enrolled
MDStudy DirectorAmgen
919 Previous Clinical Trials
925,811 Total Patients Enrolled

Media Library

AMG 193 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05975073 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Part 1: Dose Exploration of AMG 193 Combined With IDE397, Part 2: Dose Expansion of AMG 193 Combined With IDE397
Non-Small Cell Lung Cancer Clinical Trial 2023: AMG 193 Highlights & Side Effects. Trial Name: NCT05975073 — Phase 1 & 2
AMG 193 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05975073 — Phase 1 & 2

Frequently Asked Questions

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

Are individuals currently being recruited to take part in this experiment?

"Affirmative. Per the information on clinicaltrials.gov, this research project is currently enrolling subjects - first posted in August of 2023 and most recently updated a few weeks ago. 184 people have to be recruited from two seperate locations for participation in this trial."

Answered by AI

How many participants are being enrolled in this research project?

"Affirmative. According to clinicaltrials.gov, this particular research project still requires volunteers and was first published on August 1st 2023. The most recent update was made on August 24th 2023 and 184 participants will need to be recruited from 2 sites in total."

Answered by AI
~121 spots leftby Dec 2025