An Open Label, Phase 1, Treatment Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of IDE397 (MAT2A Inhibitor) In Adult Participants With Advanced Solid Tumors
Phase 1 trial for advanced solid tumors with MTAP deletion
Plain English Summary
Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion is a Phase 1 clinical trial sponsored by IDEAYA Biosciences studying Solid Tumor. This trial tests a new drug called IDE397, alone or with another drug, in adults with advanced solid tumors. It is for patients whose tumors have a specific genetic change (MTAP deletion) and have not responded to standard treatments. Participants will take the study drug by mouth or receive it by IV, and may need to undergo tumor biopsies. Alternative treatments depend on the specific cancer type and prior therapies. The trial aims to enroll 169 participants.
Official Summary
This is a Phase 1, open-label, multicenter, dose escalation and expansion study of the safety, PK, PD, and preliminary anti-tumor activity of IDE397 as a single agent and in combination with sacituzumab govitecan (SG), in adult patients with selected advanced or metastatic MTAP-deleted advanced solid tumors who are unresponsive to standard of care therapy. IDE397 is a small molecule inhibitor of methionine adenosyltransferase 2 alpha (MAT2A).
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older with advanced or metastatic solid tumors. Patients must have a confirmed MTAP deletion in their tumor. Tumors must have progressed on at least one prior treatment or be intolerant to standard therapy. Patients should have a good general health status (ECOG performance status of 0 or 1) and adequate organ function. This trial is studying Solid Tumor, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcomes measure how safe the study drugs are and determine the best dose to use for future studies, aiming to find a dose that is both effective and tolerable. The specific primary outcome measures are: Dose-limiting Toxicities (DLTs) of IDE397 (21 days following the first dose of IDE397); Dose-limiting Toxicities (DLTs) of IDE397 in combination with sacituzumab govitecan (21 - 28 days following the first dose of IDE397); Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397 (Approximately 2 years); Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397 in combination with sacituzumab govitecan (Approximately 2 years); To evaluate preliminary anti-tumor activity of IDE397 as monotherapy and in combination with sacituzumab govitecan-hziy in expansion arms (Approximately 2 years). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.
Why This Trial Matters
This trial addresses a gap in treatment for advanced solid tumors with a specific genetic alteration (MTAP deletion) for which limited options currently exist. This research targets Solid Tumor, where improved treatment options are needed.
Investor Insight
This Phase 1 trial of a novel MAT2A inhibitor in a genetically defined patient population signals a targeted approach to cancer therapy, with potential for a niche market if successful. Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if your tumor has an MTAP deletion and if this trial is a suitable option for you. Be prepared for regular clinic visits for drug administration, blood tests, and potentially tumor biopsies before and after treatment. Understand that this is an early-phase study, and the main goal is to assess safety and find the right dose. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NON_RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 169 participants
Interventions
- DRUG: IDE397 — IDE397 dosed orally
- DRUG: Sacituzumab govitecan — Intravenous infusion
Primary Outcomes
- Dose-limiting Toxicities (DLTs) of IDE397 (21 days following the first dose of IDE397)
- Dose-limiting Toxicities (DLTs) of IDE397 in combination with sacituzumab govitecan (21 - 28 days following the first dose of IDE397)
- Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397 (Approximately 2 years)
- Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397 in combination with sacituzumab govitecan (Approximately 2 years)
- To evaluate preliminary anti-tumor activity of IDE397 as monotherapy and in combination with sacituzumab govitecan-hziy in expansion arms (Approximately 2 years)
Secondary Outcomes
- Plasma Pharmacokinetics of IDE397 and metabolite (Approximately 2 years)
- Drug interaction between IDE397 and sacituzumab govitecan (Approximately 2 years)
- Pharmacodynamic effect of IDE397 as a single agent and in combination with sacituzumab govitecan (Approximately 2 years)
- Preliminary anti-tumor activity in IDE397 escalation and combination escalation arms (Approximately 2 years)
Full Eligibility Criteria
Inclusion Criteria: * 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 * Have evidence of homozygous loss of MTAP or MTAP deletion * Willing to undergo paired fresh biopsy (pre- and post-treatment) procedure. Exceptions may be made for feasibility and safety concerns * Measurable disease * ECOG performance status \<= 1 * Adequate organ function * Able to swallow and retain orally administered study treatment * Recovery from acute effects of prior therapy * Able to comply with contraceptive/barrier requirements Exclusion Criteria: * Known symptomatic brain metastases * Known primary CNS malignancy * Current active liver or biliary disease * Impairment of gastrointestinal (GI) function * Active uncontrolled infection * Clinically significant cardiac abnormalities * Active second malignancy or history of another malignancy in the past 2 years * Previous treatment with a MAT2A inhibitor and / or PRMT inhibitor or sacituzumab govitecan * Systemic anti-cancer therapy, therapeutic antibody treatment, or major surgery within 4 weeks prior to study entry * Current radiation-related toxicity or radiation therapy within 2 weeks prior to study entry * Small molecule anti-cancer treatment within 2 weeks prior to study entry * Prior irradiation to \>25% of the bone marrow * Current use or anticipated need for food or drugs that are known strong CYP3A4/5 inhibitors or inducers * Require concomitant use of proton pump inhibitor * Currently receiving another investigational study drug. * Known or suspected hypersensitivity to IDE397/excipients or components
Trial Locations
- Honor Health Research Institute, Scottsdale, Arizona, United States
- Rockefeller Cancer Institute, Little Rock, Arkansas, United States
- City of Hope, Duarte, California, United States
- Orlando Health Cancer Institute, Orlando, Florida, United States
- Indiana University Health Hospital, Indianapolis, Indiana, United States
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
- Dana Farber Cancer Institute, Boston, Massachusetts, United States
- Columbia University Medical Center - Herbert Irving Pavilion, New York, New York, United States
- Weill Cornell Medical College, New York, New York, United States
- Stephenson Cancer Center, Oklahoma City, Oklahoma, United States
- ...and 10 more locations
Frequently Asked Questions
What is clinical trial NCT04794699?
NCT04794699 is a Phase 1 INTERVENTIONAL study titled "Study of IDE397 in Participants With Solid Tumors Harboring MTAP Deletion." It is currently active, not recruiting and is sponsored by IDEAYA Biosciences. The trial targets enrollment of 169 participants.
What conditions does NCT04794699 study?
This trial investigates treatments for Solid Tumor. The primary condition under study is Solid Tumor.
What treatments are being tested in NCT04794699?
The interventions being studied include: IDE397 (DRUG), Sacituzumab govitecan (DRUG). IDE397 dosed orally
What does Phase 1 mean for NCT04794699?
Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.
What is the current status of NCT04794699?
This trial is currently "Active, Not Recruiting." It started on 2021-04-14. The estimated completion date is 2027-02-04.
Who is sponsoring NCT04794699?
NCT04794699 is sponsored by IDEAYA Biosciences. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04794699?
The trial aims to enroll 169 participants. The trial status is active, not recruiting.
How is NCT04794699 designed?
This is a interventional study, uses non_randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT04794699?
The primary outcome measures are: Dose-limiting Toxicities (DLTs) of IDE397 (21 days following the first dose of IDE397); Dose-limiting Toxicities (DLTs) of IDE397 in combination with sacituzumab govitecan (21 - 28 days following the first dose of IDE397); Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397 (Approximately 2 years); Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D) of IDE397 in combination with sacituzumab govitecan (Approximately 2 years); To evaluate preliminary anti-tumor activity of IDE397 as monotherapy and in combination with sacituzumab govitecan-hziy in expansion arms (Approximately 2 years). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04794699 being conducted?
This trial is being conducted at 20 sites, including Scottsdale, Arizona; Little Rock, Arkansas; Duarte, California; Orlando, Florida and 16 more sites (United States, Australia, France).
Where can I find official information about NCT04794699?
The official record for NCT04794699 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04794699. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04794699 testing in simple terms?
This trial tests a new drug called IDE397, alone or with another drug, in adults with advanced solid tumors. It is for patients whose tumors have a specific genetic change (MTAP deletion) and have not responded to standard treatments.
Why is this trial significant?
This trial addresses a gap in treatment for advanced solid tumors with a specific genetic alteration (MTAP deletion) for which limited options currently exist.
What are the potential risks of participating in NCT04794699?
Common side effects may include nausea, vomiting, diarrhea, fatigue, and low blood cell counts. Specific risks related to IDE397 and sacituzumab govitecan will be discussed by the study team. The need for tumor biopsies may cause discomfort or minor bleeding at the biopsy site. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04794699?
Ask your doctor if your tumor has an MTAP deletion and if this trial is a suitable option for you. Be prepared for regular clinic visits for drug administration, blood tests, and potentially tumor biopsies before and after treatment. Understand that this is an early-phase study, and the main goal is to assess safety and find the right dose. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04794699 signal from an investment perspective?
This Phase 1 trial of a novel MAT2A inhibitor in a genetically defined patient population signals a targeted approach to cancer therapy, with potential for a niche market if successful. This is a Phase 1 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participants will take the study drug by mouth or receive it by IV, and may need to undergo tumor biopsies. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.