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Small Molecule Inhibitor

IDE397 for Solid Tumors

Phase 1
Recruiting
Research Sponsored by IDEAYA Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant must be at least 18 years of age
Advanced or metastatic solid tumor that has progressed on at least one prior line of treatment or is intolerant to additional effective standard therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years
Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of IDE397 as a treatment for advanced solid tumors.

Who is the study for?
This trial is for adults with advanced solid tumors that have a specific genetic change (MTAP deletion) and haven't responded to standard treatments. Participants must be over 18, recovered from previous therapies, able to take oral medication, and willing to use contraception. They should not have significant heart issues, active liver disease, brain metastases or be on certain drugs affecting the liver enzyme CYP3A4/5.Check my eligibility
What is being tested?
The study tests IDE397 alone or with chemotherapy drugs docetaxel or paclitaxel in patients with MTAP-deleted tumors. It's an early-phase trial assessing safety, how the body processes the drug (pharmacokinetics), its effects on the tumor (pharmacodynamics), and potential anti-cancer activity.See study design
What are the potential side effects?
Potential side effects include reactions related to IDE397 which could affect various organs due to its mechanism as a MAT2A inhibitor. Chemotherapy may cause hair loss, nausea, fatigue, increased risk of infection among others. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My cancer has worsened after treatment or I cannot tolerate standard therapy.
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My cancer has a specific genetic change called MTAP loss.
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I can swallow and keep down pills.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 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
Dose-limiting Toxicities (DLTs) of IDE397
Dose-limiting Toxicities (DLTs) of IDE397 in combination with either docetaxel or paclitaxel
Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397
+2 more
Secondary outcome measures
Drug interaction between IDE397 and docetaxel or paclitaxel
Pharmacodynamic effect of IDE397 as a single agent and in combination with either docetaxel or paclitaxel
Plasma Pharmacokinetics of IDE397 and metabolite
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: Part 4: Combination Dose Expansion with docetaxel or paclitaxel (NSCLC, EG and Urothelial)Experimental Treatment3 Interventions
Group II: Part 3: Combination Dose Escalation with docetaxel or paclitaxel (NSCLC, EG and Urothelial)Experimental Treatment3 Interventions
Group III: Part 2: Monotherapy Dose Expansion (NSCLC, EG and Urothelial)Experimental Treatment1 Intervention
Group IV: Part 1: Dose Escalation Monotherapy (Solid Tumors)Experimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Docetaxel
1995
Completed Phase 4
~5620
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

IDEAYA BiosciencesLead Sponsor
4 Previous Clinical Trials
808 Total Patients Enrolled
Jasgit Sachdev, MDStudy DirectorIDEAYA Biosciences
3 Previous Clinical Trials
385 Total Patients Enrolled

Media Library

IDE397 (Small Molecule Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04794699 — Phase 1
Solid Tumors Research Study Groups: Part 3: Combination Dose Escalation with docetaxel or paclitaxel (NSCLC, EG and Urothelial), Part 4: Combination Dose Expansion with docetaxel or paclitaxel (NSCLC, EG and Urothelial), Part 2: Monotherapy Dose Expansion (NSCLC, EG and Urothelial), Part 1: Dose Escalation Monotherapy (Solid Tumors)
Solid Tumors Clinical Trial 2023: IDE397 Highlights & Side Effects. Trial Name: NCT04794699 — Phase 1
IDE397 (Small Molecule Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04794699 — 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 medical facilities are engaged in this research endeavor?

"A multitude of locations are available for enrolment in this trial, including The Sarah Cannon Research Institute/Tennessee Oncology in Nashville, Honor Health Research Institute in Scottsdale, and Next Oncology in San Antonio."

Answered by AI

How many participants have enrolled in the research project so far?

"This clinical trial requires 382 qualified participants from various locales, such as The Sarah Cannon Research Institute/Tennessee Oncology in Nashville and Honor Health Research Institute in Scottsdale. Eligible individuals must meet the stipulated inclusion criteria to join this medical study."

Answered by AI

What safety data is available concerning the use of IDE397 in patients?

"As this is a Phase 1 trial, there are limited data points in regards to IDE397's safety and efficacy. Therefore, our team at Power has assigned it an assessment score of 1."

Answered by AI

What results are investigators hoping to attain from this trial?

"Assessed over a period of 21 to 28 days post the initial dose, this clinical trial's primary outcomes are Objective Response Rate (ORR) and Duration of Response (DoR). Secondary objectives include determining preliminary anti-tumor activity with IDE397 escalation or in combination with docetaxel, paclitaxel, gemcitabine plus nab-paclitaxel or pemetrexed; understanding Plasma Pharmacokinetics for both IDE397 and its metabolites when administered alone or combined with other drugs; and elucidating any drug interaction between IDE397 and aforementioned medications."

Answered by AI

Is there an opportunity to join the current trial?

"Records on clinicaltrials.gov reveal that this research is still actively seeking participants, with the opening study posting taking place back in April 14th 2021 and its most recent update occurring July 20th 2022."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion
2021. "Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04794699.
~32 spots leftby Apr 2025
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