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진행성 고형암 환자를 위한 XYA02 평가 임상시험

Evaluation of XYA02 in Patients With 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 NCT07670312
상태 모집 중
단계 1상/2상
시험 약물/중재 XYA02
대상 질환 MUC1-expressing Advanced, Relapsed and/or Refractory Solid Tumors, Non-Small Cell Lung Cancer, Ovarian Cancer, GEJ Adenocarcinoma, Colorectal Cancer, Pancreatic Adenocarcinoma
스폰서 XYone Therapeutics, Inc
연령·성별 18 Years ~ 제한 없음 · ALL
목표 인원 190
시작 / 1차 완료 예정 2026-09-17 / 2029-09-15
국내 실시기관 없음
실시 국가 1개국, 기관 5곳 (Australia)
결과 게시 아니오
최근 갱신 2026-09-25

문의처 (등록된 중앙 연락처)

  • Tiffany Sepp 617-710-0770 clinicaltrial@xyonetx.com
  • Anshu Goyal 917-445-1846 clinicaltrial@xyonetx.com

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

시험 개요

이 연구는 진행성 고형암 환자를 대상으로 신약 XYA02의 안전성, 내인성, 유효성을 평가합니다. XYA02는 악성 종양 치료를 위해 개발 중인 항체 약물 접합체(antibody drug conjugate, ADC)입니다. 본 연구는 1상 용량 증량 파트와 2상 용량 확장 파트로 나누어 진행되는 최초인체적용(first-in-human) 임상시험입니다. 목표 환자 수는 190명이며, 췌장암을 포함한 다양한 고형암 환자가 대상에 포함됩니다.

  • 대상 질환은 MUC1 발현 진행성, 재발성 및/또는 난치성 고형암입니다.
  • 임상시험은 1상 용량 증량과 2상 용량 확장 파트로 구성되어 있습니다.
  • 목표 환자 수는 총 190명입니다.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: - 스크리닝 시 서면 동의서를 서명한 환자 - RECIST 1.1 기준에 따라 측정 가능한 병병이 있는 재발성/난치성 종양 환자 - 스크리닝 시 연령 18세 이상 - 동유럽종양학협력그룹(ECOG) 수행능력 평가 0-1인 환자 - 스크리닝 시 혈소판(PLT) 수 100,000/mcL 이상, 헤모글로빈 9.5 g/dL 이상, 절대호중구수(ANC) 1,500/mcL 이상 - 예상 크레아티닌 청소율(CrCl) > 60 mL/min, ALT/AST는 정상상한치의 3배 이하, 총 빌리루빈은 정상상한치의 1.5배 이하(질베르 증후군 환자는 3배 이하) - 2상 코호트 2E에 췌장암 환자 포함 (최소 1차 이상의 전신 치료 후 재발 또는 불응성, 진행성 질환에 대해 3차 치료 요법 이내)

제외 기준: - 연구자의 판단에 따라 이전의 토포이소머라제 1(TOP1) 억제제 항체-약물 접합체 치료에 불응성인 환자 - 증상성 울혈성 심부전, LVEF < 50%, 또는 치료가 필요한 심각한 부정맥 병력이 있는 환자 - 스크리닝 전 6개월 이내의 심근경색 또는 불안정형 협심증 병력 - QTcF가 남성과 여성 모두 470 밀리초(ms)를 초과하는 환자

선정/제외 기준 원문 (영어)

Inclusion Criteria:

  1. Signed informed consent form(s) (ICFs) obtained at Screening.
  2. Has an eligible relapsed/refractory tumor with measurable disease based on RECIST 1.1 at Screening.
  3. Age ≥18 years at Screening and confirmed at the discretion of the Investigator.
  4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 at Screening.
  5. Platelet (PLT) count ≥100,000/mcL at Screening.
  6. Hemoglobin ≥9.5 g/dL without packed red blood cells (RBCs) transfusion within 14 days prior to Screening.
  7. Absolute neutrophil count (ANC) ≥1,500/mcL at Screening.
  8. Estimated creatinine clearance (CrCl) >60 mL/min at Screening. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) ≤3 × the upper limit of normal (ULN) at Screening.

10. Total bilirubin ≤1.5 × ULN at Screening; in patients with a documented history of Gilbert syndrome ≤3 × ULN.

11. At least 28 days from treatment with monoclonal antibody-based therapies at Screening.

12. At least 5 half-lives from treatment with chemotherapy and small molecule inhibitors at Screening. 13. At least 28 days from experimental therapies not covered above at Screening.

14. At least 28 days from radiation to more than 30% of the bone marrow or a wide field of radiation at Screening. Radiotherapy with a limited field of radiation for palliation within 14 days of the first dose of study drug is acceptable. (In case of patients treated with radiotherapy, previously irradiated lesions should not be considered a target lesion on computed tomography [CT] unless evidence of regrowth/disease progression has been documented.) 15. At least 28 days from major surgery or significant trauma with recovery of AEs to NCI-CTCAE Grade 1 or baseline at Screening.

16. Availability of archival tissue or, if unavailable, will be willing to undergo a tumor biopsy if a low-risk biopsy procedure is feasible at Screening. 17. Has a life expectancy of ≥ 3 months at Screening.

Additional Inclusion Criteria for Phase 1 (Dose Escalation and Backfill):

18. Has pathologically documented advanced, relapsed, or refractory NSCLC (non-squamous), ovarian (high grade serous), gastric/esophageal/GEJ adenocarcinoma, or CRC at Screening. 19. Patient must have progressed on, have relapsed after, be refractory to, or be intolerant of at least 1 prior systemic therapy, without available subsequent standard of care and have no satisfactory alternative treatment options. No more than 4 prior lines of systemic therapy for advanced, relapsed, or refractory disease in NSCLC and ovarian and no more than 3 prior lines of systemic therapy in gastric/esophageal/GEJ adenocarcinoma or CRC (excluding adjuvant chemotherapy).

Additional Inclusion Criteria for Phase 2 (Dose Expansion):

20. Cohorts for 5 different prioritized tumor types and 1 basket cohort that are advanced/unresectable or metastatic at Screening according to the following criteria:

  1. Cohort 2A: NSCLC non-squamous. Histologically confirmed locally advanced or metastatic NSCLC (non-squamous) that have relapsed after or are refractory to platinum-doublet based chemotherapy and/or immune checkpoint inhibitor (in combination or sequential). Patients with EGFR or anaplastic lymphoma kinase (ALK) mutations should have been treated with appropriate targeted therapy. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy and/or immunotherapy).
  2. Cohort 2B: Ovarian. Histologically confirmed advanced or metastatic high-grade serous ovarian cancer that have relapsed after or are refractory to at least 1 prior line of chemotherapy and have no other satisfactory treatment options. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy or maintenance regimen).
  3. Cohort 2C: Gastric/esophageal/GEJ adenocarcinoma. Histologically confirmed advanced or metastatic gastric, esophageal or GEJ adenocarcinoma that have relapsed after or are refractory to at least 1 prior line of therapy. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy).
  4. Cohort 2D: CRC. Histologically confirmed advanced or metastatic CRC that have relapsed after or are refractory to at least 1 prior line of therapy. BRAF mutated patients are excluded. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy).
  5. Cohort 2E: Pancreatic cancer. Histologically confirmed locally advanced or metastatic pancreatic cancer that have relapsed after or are refractory to at least 1 prior systemic treatment regimen. Patients must have received no more than 3 prior treatment regimens for advanced disease (excluding adjuvant chemotherapy).
  6. Cohort 2F: Tumor agnostic. Histologically confirmed advanced or metastatic solid tumors other than ones in Cohorts 2A to 2E that have relapsed after treatment without available subsequent standard of care. The tumor indications in this group will be selected based on data from phase 1 and preclinical data.

Exclusion Criteria:

  1. Has been refractory (did not have a tumor response) to previous treatment with a topoisomerase 1 (TOP1) inhibitor antibody-drug conjugate, at the discretion of the investigator.
  2. Has a medical history of symptomatic congestive heart failure (CHF; New York Heart Association [NYHA] classes II-IV), prior documented left ventricular ejection fraction (LVEF) \< 50%, or serious cardiac arrhythmia requiring treatment at Screening and at the discretion of the Investigator.
  3. Has a clinically significant medical history of myocardial infarction or unstable angina within 6 months before Screening at the discretion of the Investigator.
  4. Has a QT corrected for heart rate by Fridericia's formula (QTcF) > 470 millisecond (ms) in males and > 470 ms in females based on a 12-lead electrocardiogram (ECG) in triplicate performed at Screening.
  5. Has a medical history of clinically significant lung diseases (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or who are suspected to have these diseases by imaging at Screening at the discretion of the Investigator.
  6. Has an uncontrolled infection requiring IV injection of antibiotics, antivirals, or antifungals at Screening at the discretion of the Investigator.
  7. Known history of human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection at Screening. If known history of hepatitis, active hepatitis B infection is defined as hepatitis B surface antigen (HbsAg) positive or hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive; and active hepatitis C infection is defined as hepatitis C virus (HCV) ribonucleic acid (RNA) positive.
  8. Is a lactating mother (women who are willing to temporarily interrupt breastfeeding will also be excluded), or pregnant as confirmed by pregnancy tests performed within 7 days before Screening.
  9. Male and female patients who are unwilling to use contraceptive methods at Screening (eg, concomitant use of a spermicidal agent and barrier contraceptive, intrauterine contraceptive during the study and for at least 7 months after the last dose of XYA02).
  10. Has clinically active brain metastases, defined as untreated and symptomatic, or requires therapy with steroids or anticonvulsants to control associated symptoms at Screening and at the discretion of the Investigator. Note: Patients with untreated asymptomatic brain metastases may be included in the study if they do not require radiotherapy treatment or surgical treatment, do not require treatment with steroids, and there are no untreated brain lesions > 20 mm in size.
  11. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia, lymphopenia) not yet resolved to NCI-CTCAE Grade ≤ 1 or baseline at Screening. Patients with chronic Grade 2 toxicities may be eligible per the discretion of the Investigator (eg, peripheral neuropathy, endocrinopathies).
  12. Has a concomitant medical condition that would increase the risk of toxicity at Screening.
  13. Has known hypersensitivity to either the drug substances or inactive ingredients in the drug product at Screening.
  14. Has multiple primary malignancies within 3 years, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, other solid tumors curatively treated, or contralateral breast cancer at Screening.

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

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