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MTAP 결손 진행성 고형암 환자를 대상으로 한 IDE892 단독 및 병용 요법 제1상 임상시험

A Study of IDE892 as Monotherapy and Combination in MTAP-deleted Advanced Solid Tumors

안내

이 페이지는 자동 수집·AI 요약된 정보입니다. 의료 조언이 아니며, 치료 결정은 반드시 담당 의료진과 상의하세요. 응급 상황은 응급 가이드 또는 119.

항목 내용
등록번호 NCT07277413
상태 모집 중
단계 1상
시험 약물/중재 IDE892, IDE397
대상 질환 NSCLC Adenocarcinoma, Gastroesophageal Cancer (GC), Gastric Adenocarcinoma, Adenocarcinoma of Esophagus, Squamous Cell Car. - Esophagus, Urothelial Carcinoma (UC)
스폰서 IDEAYA Biosciences
연령·성별 18 Years ~ 제한 없음 · ALL
목표 인원 260
시작 / 1차 완료 예정 2026-03-04 / 2028-04-30
국내 실시기관 없음
실시 국가 1개국, 기관 23곳 (United States)
결과 게시 아니오
최근 갱신 2026-09-28

문의처 (등록된 중앙 연락처)

  • IDEAYA Clinical Trials +1 855 433 2246 IDEAYAClinicalTrials@ideayabio.com

국내 기관 참여 문의는 해당 병원 임상시험센터 또는 담당 주치의를 통해 하세요. 참여 방법 안내

시험 개요

본 임상시험은 메틸티오아데노신 포스포릴라제(MTAP, methylthioadenosine phosphorylase)가 결손된 진행성 고형암 성인 환자를 대상으로 신약 IDE892의 단독 요법 및 IDE397 병용 요법의 안전성, 효능, 약동학(PK)을 평가합니다. 표준 치료 후 진행되었고 미충족 의료 수요가 높은 환자들을 대상으로 합니다. 현재 단계에서는 메티오닌 아데노실전이효소 2A(MAT2A, methionine adenosyltransferase 2A) 경구 억제제인 IDE397과의 병용에 초점을 맞추고 있습니다. 총 목표 인원은 260명입니다.

  • 대상 질환은 MTAP 결손이 확인된 진행성·전이성 고형암(췌장암, 비소세포폐암, 담도암 등 포함)입니다.
  • 목표 인원은 총 260명이며, 제1상(PHASE1) 임상시험으로 진행됩니다.
  • IDE892 단독 투여 또는 MAT2A 억제제인 IDE397과의 병용 투여를 평가합니다.
  • 국내 기관은 초록에 명시되지 않음.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준:- 18세 이상 성인- 조직학적으로 확인된 MTAP 결손 진행성·전이성 고형암(용량 증량 시 췌장암, 담도암, 비소세포폐암 등 포함)- 조직 검사 또는 바이오마커 검사를 위한 혈액 및 종양 조직 제공 동의- RECIST v1.1 기준 최소 1개의 측정 가능한 병병 보유- ECOG 수행 능력 평가(PS) 점수 0 또는 1- 예상 여명 3개월 초과- 적절한 골수 및 장기 기능 보유제외 기준:- 뇌 전이가 있거나 전신 코르티코스테로이드가 필요한 증상이 있는 경우- 중추신경계(CNS) 원발성 악성종양 보유- 첫 투여 전 2년 이내 다른 악성종양 병력(일부 예외 있음)- 임상적으로 유의미한 심장 질환 또는 심기능 저하- 조절되지 않는 흉수, 복수, 심낭수 보유- 활동성 중증 감염 병력- 약물로 조절되지 않는 고혈압- 인간면역결핍바이러스(HIV) 또는 바이러스성 간염 양성 반응- 이전 항종양 치료로 인한 독성이 CTCAE 1등급 이하로 회복되지 않은 경우- 최근 화학요법, 면역요법, 표적치료제 등을 투여받은 이력이 있는 경우(기간별 상이)- 양성자펌프억제제(PPI) 사용 이력 또는 임상 중 사용 계획- MAT2A 억제제 및/또는 PRMT 억제제 치료 이력 있음

선정/제외 기준 원문 (영어)

Inclusion Criteria:

  • Are ≥ 18 years of age (or the minimum age of consent in accordance with local regulations) at the time of signing the ICF.
  • Have a histologically confirmed diagnosis of a locally advanced recurrent or metastatic solid tumor type of interest with MTAP deletion (for dose escalation: mesothelioma [pleural or peritoneal], gastroesophageal cancers [squamous and adenocarcinoma of esophagus, gastric adenocarcinoma, gastroesophageal junction cancers], pancreatic adenocarcinoma and biliary tract carcinomas (intrahepatic and extrahepatic cholangiocarcinoma, and gallbladder cancer), NSCLC [adenocarcinoma, squamous cell carcinoma, and adeno-squamous] or UC [including mixed urothelial-squamous histology]; for dose expansion: NSCLC that has progressed on at least one prior line of treatment and for which additional effective standard therapy is not available or for which the participant is not a candidate due to intolerance).
  • Are willing and able to provide blood/tumor tissue samples for biomarker testing. An archival tumor tissue specimen must be provided for central confirmation of MTAP loss.
  • Must be willing and able to provide the blood/serum/plasma samples
  • Have evidence of homozygous loss of MTAP or MTAP deletion (pre-screening available after signing pre-screening ICF)
  • Have at least 1 measurable lesion according to RECIST version 1.1
  • Have Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 or 1
  • Have life expectancy > 3 months
  • Have adequate bone marrow and organ function
  • Able to swallow and retain orally administered study drug/IMP.
  • Are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures
  • Male and female: willing to use contraception

Exclusion Criteria:

  • Known symptomatic brain metastases requiring supraphysiologic doses of systemic corticosteroids
  • Have a known primary central nervous system (CNS) malignancy
  • Have had other malignancies within 2 years prior to the first dose, with some exceptions
  • Impaired cardiac function or clinically significant cardiac diseases
  • Have presence of uncontrolled pleural, peritoneal, or pericardial effusion within 2 weeks before the first study dose, requiring recurrent drainage procedures or an indwelling drainage catheter
  • Have a history of severe infections within 4 weeks prior to the start of study treatment
  • Hypertension (e.g., > 150/100 mmHg) that cannot be controlled by medications despite optimal medical therapy
  • Other acute or chronic medical or psychiatric condition
  • Have a history of immunodeficiency, with a positive human immunodeficiency virus(HIV) test at screening
  • Known or suspected viral hepatitis with a positive test at screening
  • Had an adverse reaction to a previous antitumor treatment that has not recovered to CTCAE Grade ≤ 1
  • Have received chemotherapy within 4 weeks of the first dose of IMP; immunotherapy or biologic targeted antitumor treatments within 2 weeks before the first dose of IMP; small molecule inhibitors within 2 weeks before the first dose of IMP, or other investigational products within 4 weeks
  • Current radiation-related toxicity or radiation therapy within 2 weeks before the first dose of IMP
  • Administration of any of the following within 2 weeks before the first dose of IDE892 as a monotherapy: Strong inhibitors or inducers of cytochrome P450, Strong inhibitors of P-glycoprotein, Narrow therapeutic index and sensitive substrates of multidrug and toxin extrusion (MATE)1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and breast cancer resistance protein
  • Administration of any of the following within 2 weeks before the first dose of IDE892: Strong inhibitors or inducers of CYP3A4/5, Strong inhibitors of P-gp and/or BCRP, Narrow therapeutic index and sensitive substrates of MATE1 and MATE2-K, Narrow therapeutic index and sensitive substrates of P-gp and BCRP
  • Use of proton pump inhibitors (PPIs) within 7 days prior to the first dose of IMP or planned use during the study
  • Use of drugs with known risk for QT prolongation within 2 weeks prior to the first dose of IDE892
  • Previous treatment with a Amethionine adenosyltransferase 2A (MAT2A) inhibitor and/or Protein arginine N-methyltransferase (PRMT) inhibitor
  • Major surgery within 4 weeks before study entry
  • Prior irradiation to > 25% of the bone marrow
  • Known or suspected hypersensitivity to IDE892

Disease-Specific Eligibility Criteria Eligibility Criteria for Participants with NSCLC (All Parts)

  • Must have histologically confirmed diagnosis of advanced or metastatic NSCLC that has progressed after prior treatment with platinum chemotherapy and a PD-1/PD-L1 inhibitor (unless contraindicated or participant developed intolerance) in the metastatic setting
  • Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease.
  • If considered standard of care and available, participants whose cancers have proven targetable oncogene alterations must have had disease progression on (unless contraindicated or participant developed intolerance) at least 1 prior line containing appropriate targeted therapy.

Eligibility Criteria for Participants with Urothelial Cancer (Bladder and Upper Urinary Tract), Mesothelioma (Pleural or Peritoneal), Pancreatic Adenocarcinoma or Biliary Tract Carcinomas (Intrahepatic and Extrahepatic Cholangiocarcinoma, and Gallbladder Cancer) (Parts 1 and 3)

  • Must have histologically confirmed diagnosis of advanced or metastatic UC, mesothelioma, gastroesophageal cancer or pancreatic and biliary tract tumors
  • Must have progressed following at least 1 prior line of therapy
  • Treatment with no more than 3 prior lines in the setting of advanced or metastatic disease

출처: ClinicalTrials.gov · 수집 2026-10-06 · 갱신 2026-10-06

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