Clinical Trials List
Protocol NumberIDE397-001
2023-05-01 - 2025-12-31
Phase I
Recruiting2
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
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Trial Applicant
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 徐偉勛 Division of Hematology & Oncology
- Wei-Wu Chen Division of Hematology & Oncology
- Jih-Hsiang Lee Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yu-Min Yeh Division of Hematology & Oncology
- 鍾秉軒 無
- Wu-Chou Su Division of Hematology & Oncology
- Seu-Chun Yang Division of Hematology & Oncology
- Wen-Pin Su Division of Hematology & Oncology
- Chin-Wei Kuo Division of Hematology & Oncology
- Chien-Chung Lin Division of Hematology & Oncology
- Shang-Yin Wu Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Solid Tumor
Objectives
main purpose
‧ To assess the safety and tolerability of increasing IDE397 dose levels in a consecutive cohort of participants with selected advanced or metastatic solid tumors to estimate the maximum tolerated dose (MTD) and/or recommend a phase 2 dose (RP2D)/Time Course (Part 1: IDE397 Alone Treatment Dose Escalation).
‧ Further evaluate the safety and tolerability of IDE397 (MTD and/or RP2D) monotherapy (Part 2: IDE397 monotherapy dose expansion).
‧ To evaluate the safety and tolerability of coadministration of docetaxel, paclitaxel, gemcitabine and nab-paclitaxel or pemetrexed at increasing dose levels of IDE397 (Part 3: Coadministration of IDE397 with docetaxel or paclitaxel in dose escalation, Part 5: IDE397 with Gemcitabine + Therapeutic dose escalation for nab-paclitaxel coadministration, Part 7: Therapeutic dose escalation for coadministration of IDE397 with pemetrexed).
‧ Further evaluation of the safety and tolerability of IDE397 (MTD and/or RP2D) with docetaxel, paclitaxel, gemcitabine and nab-paclitaxel or pemetrexed (Part 4: Therapeutic dose expansion of IDE397 with docetaxel or paclitaxel, Part 6: IDE397 Therapeutic Dose Expansion with Coadministration of gemcitabine and nab-paclitaxel, Part 8: Therapeutic Dose Expansion with Coadministration of IDE397 with Pemetrexed).
‧ Assessment of preliminary anti-tumor activity (Parts 2, 4, 6, 8).
secondary purpose
‧ To investigate the single-dose and multiple-dose pharmacokinetics (PK) of IDE397 and its metabolites after oral administration as single agents and in combination with docetaxel, paclitaxel, gemcitabine, and nab-paclitaxel or pemetrexed (all fractions).
‧ Evaluation of drug interactions between IDE397 and paclitaxel or docetaxel (Parts 3 and 4).
‧ Evaluate drug interactions between IDE397 and nab-paclitaxel or Gemcitabine (Parts 5 and 6).
‧ Evaluation of drug interactions between IDE397 and pemetrexed (sections 7 and 8).
‧ To evaluate the PD effect of IDE397 as a single agent and in combination with docetaxel, paclitaxel, gemcitabine and nab-paclitaxel or pemetrexed (all parts).
‧ Assessment of preliminary anti-tumor activity (Parts 1, 3, 5, 7).
‧ Evaluated by the Blind Imaging Review Committee (BICR) (Parts 1, 2, 3, 4, 5, 6, 7, 8) IDE397 administered as a single agent and in combination with docetaxel, paclitaxel, gemcitabine, nab-paclitaxel, and pemetrexed The final therapeutic effect.
Tertiary/exploratory/other purposes
‧ Explore any correlations between tumor genetic and molecular profiles and response to IDE397 (all sections).
‧ Explore the prediction and PD effects of IDE397 on responding tumors and cell-free DNA (all sections).
‧ Explore the metabolite profile of IDE397 in tumors and plasma (all sections).
‧ Further exploration of the preliminary anti-tumor activity of IDE397 (all parts).
‧ Assessment of urinary excretion of IDE397 and metabolites (Part 1).
‧ Correlation of PK/PD results (all parts).
‧ Evaluating early response in participants with gastroesophageal cancer (EG) using positron tomography/computed tomography (PET/CT) (Part 2, Cohort 2).
‧ Food impact trial: To evaluate the impact of food on the pharmacokinetics of IDE397 in cancer patients.
Test Drug
IDE397
Active Ingredient
IDE397
Dosage Form
tablet
Dosage
15 mg/tablet, 50 mg/tablet
Endpoints
‧ Incidence of dose-limiting toxicities (DLT).
‧ Explore treatment-emergent adverse events by type, frequency, severity (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE, version 5.0]), timing, severity, and relevance to trial treatment incidence.
‧ Explore laboratory test abnormalities according to type, frequency, severity (graded according to NCI CTCAE version 5.0), and time.
‧ Tumor response: Objective response rate (ORR) and duration of response (DoR) as assessed by the trial sponsor using Response Evaluation Criteria in Solid Tumors (RECIST version 1.1, Appendix 7).
‧ Explore treatment-emergent adverse events by type, frequency, severity (graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI-CTCAE, version 5.0]), timing, severity, and relevance to trial treatment incidence.
‧ Explore laboratory test abnormalities according to type, frequency, severity (graded according to NCI CTCAE version 5.0), and time.
‧ Tumor response: Objective response rate (ORR) and duration of response (DoR) as assessed by the trial sponsor using Response Evaluation Criteria in Solid Tumors (RECIST version 1.1, Appendix 7).
Inclution 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
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
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
Previous treatment with a MAT2A inhibitor and / or PRMT inhibitor or sacituzumab govitecan
Systemic anti-cancer therapy or major surgery within 4 weeks prior to study entry
Radiation therapy 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
Currently receiving another investigational study drug.
Known or suspected hypersensitivity to IDE397/excipients or components
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
Previous treatment with a MAT2A inhibitor and / or PRMT inhibitor or sacituzumab govitecan
Systemic anti-cancer therapy or major surgery within 4 weeks prior to study entry
Radiation therapy 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
Currently receiving another investigational study drug.
Known or suspected hypersensitivity to IDE397/excipients or components
The Estimated Number of Participants
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Taiwan
5 participants
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Global
382 participants
