진행성 고형암 환자를 대상으로 하는 신약 CT3001의 임상 1/2b상 시험

A Study to Determine the Effect of CT3001 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	NCT06598007
상태	모집 중
단계	1상/2상
시험 약물/중재	CT3001, FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
대상 질환	Solid Tumor, Adult, Colorectal Cancer, Pancreatic Ductal Adenocarcinoma
스폰서	Crossignal Therapeutics, Inc.
연령·성별	18 Years ~ 제한 없음 · ALL
목표 인원	78
시작 / 1차 완료 예정	2024-09-20 / 2027-06-20
국내 실시기관	없음
실시 국가	1개국, 기관 1곳 (United States)
결과 게시	아니오
최근 갱신	2026-05-29

문의처 (등록된 중앙 연락처)

• Can Zhang 413-932-9263 czhang@crossignaltherapeutics.com

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

시험 개요

본 임상시험은 진행성 고형암 환자를 대상으로 G-protein coupled receptor 35(GPR35) 억제제인 CT3001의 안전성, 내인성, 약동학(PK), 약력학(PD) 및 예비 효능을 평가하기 위한 다기관, 공개, 용량 증량 및 용량 최적화 연구입니다. 임상 1상은 표준 치료가 없는 진행성 고형암 환자를 대상으로 CT3001 단독 투여의 용량 증량을 진행합니다. 임상 2b상은 FOLFOX 항암화학요법 치료가 가능한 진행성 대장암(CRC) 환자를 대상으로 CT3001과 표준 치료(SOC) 항암화학요법의 병용 요법을 평가합니다. 전체 목표 인원은 78명이며, 현재 환자를 모집 중입니다.

• 임상시험의 목표 인원은 총 78명입니다.
• 임상 1상에서는 진행성 고형암 환자에서 CT3001의 최대내용량(MTD)과 권장 용량(RP2D)을 찾기 위해 최대 7개 용량 수준에서 용량 증량을 평가합니다.
• 임상 2b상에서는 진행성 대장암(CRC) 환자를 대상으로 CT3001과 표준 치료인 FOLFOX 병용 요법의 안전성과 예비 효능을 평가합니다.

참여 조건 (AI 정리, 원문 확인 필요)

선정 기준: - 만 18세 이상 성인. - 표준 치료에 불응하거나 가용한 표준 치료가 없는 조직학적/세포학적으로 확진된 국소 진행성 절제 불가능 또는 전이성 고형암 (임상 2b상은 FOLFOX 재투여가 가능한 진행성 대장암 환자만 해당). - RECIST 버전 1.1에 따른 측정 가능한 병변 존재. - 연구자의 판단에 따른 예상 생존기간이 3개월 이상. - ECOG 수행 능력 상태 0 또는 1. - 적절한 골수 기능, 간 기능, 신장 기능을 충족하는 자.

제외 기준: - 임상 1상 용량 증량 기간 동안 병용 항암 치료를 받는 자 (임상 2b상의 표준 치료 항암화학요법은 제외). - CT3001 첫 투여 전 일정 기간 내에 다른 임상시험용 의약품이나 항암 의료기기를 사용한 자. - 심각하거나 조절되지 않는 전신 질환, 감염이 있는 자. - 임신 중이거나 수유 중인 여성. - CT3001 투여 시작 전 4주 이내에 대수술을 받았거나 외상성 손상이 있는 자. - QTcF 간격이 470 ms를 초과하거나 Torsade de Pointes 위험 인자가 있는 자. - B형간염 표면항원(HBsAg), C형간염 항체(HCV), 혹은 인간면역결핍바이러스(HIV) 양성인 자 (단, 바이러스 억제 치료 중인 만성 B형간염 등 예외 기준 충족 시 허용).

선정/제외 기준 원문 (영어)

Inclusion Criteria:

• Able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures.
• Aged ≥ 18 years (or adult age as per local regulations).
• Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors that are refractory to standard therapy, or for whom no standard therapy exists. Note: In Phase 2b, only participants with advanced CRC who are eligible for re-engaging FOLFOX will be enrolled.
• Has measurable disease per RECIST Version 1.1. that was not in a prior radiation or other locally treated area unless imaging-based progression has been clearly documented following radiation or other local therapy.
• Life expectancy ≥ 3 months, in the opinion of the PI or designee.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate hematologic, liver, and kidney function as follows:

Bone marrow reserve:

1. Absolute neutrophil count ≥ 1.5 × 10\^9/L without growth factor support in the 2 weeks prior to study entry.
2. Hemoglobin ≥9.0 g/dL without transfusion, growth factor support, or other supportive medication in the 2 weeks prior to study entry.
3. Platelet count ≥ 75 × 10\^9/L without transfusion in 2 weeks prior to study entry.

Hepatic function:

1. Serum TBIL \< 1.5 × ULN.
2. AST and ALT \< 3 × ULN.

Renal function:

Serum creatinine clearance (CrCL) > 60 mL/min, as per the Cockcroft-Gault Equation:

CGGFR = [(140 - age in years) × weight in kg] / (7.2 × serum creatinine in mg/dL) (× 0.85 for females) (for urine protein \< 2+; if urine protein > 2+, 24-hour urinary protein quantity should be measured and must be \< 1.0 g).

• Coagulation tests: international normalized ratio (INR) \< 1.5, activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN (Note: for those on oral anticoagulants, an INR in the range of 2 to 3 is acceptable).
• Participants (both males and females) of childbearing potential should be willing to use a viable contraception method that is deemed effective by the PI or designee from Screening, during the study, and for at least 3 months following the last dose of IP. Postmenopausal women must have been amenorrheal for at least 12 months to be considered of non-childbearing potential; postmenopausal status, if not known, is to be confirmed through testing of follicle-stimulating hormone (FSH) levels of ≥ 40 IU/L. Male participants must be willing not to donate sperm until 3 months following the last IP administration.

Exclusion Criteria:

• During Phase 1 Dose Escalation, receiving concurrent anticancer treatment (including chemotherapy, targeted drugs, radiotherapy [excluding the following small-area radiotherapy for bone metastasis], endocrine therapy, antitumor traditional Chinese Medicine), except during Phase 2b, Standard Care Chemotherapy (FOLFOX-based regimen) for advanced CRC patients is allowed.
• Use of other IP within 5 half-lives of the product (if the IP is a small molecule) or anti-cancer investigational medical device within two weeks prior to the first administration of CT3001. Prior use of investigational monoclonal antibody IP can be permitted upon obtaining an approval from the Sponsor. Use of these investigational IP or devices are not permitted for the duration of treatment with CT3001.
• Evidence of severe or uncontrolled systemic diseases, infection, or laboratory finding that in the view of the PI or designee makes it undesirable for the patient to participate in the trial.
• Females who are pregnant or nursing, or any participant who is planning to become pregnant (self or partner) at any time during the study, including the Follow-up Period.
• Has had major surgery or significant traumatic injury within 4 weeks of start of CT3001; participants have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or participant might require major surgery during the course of the study.
• Has a prolonged QT interval corrected by Fredericia's formula (QTcF interval) of > 470 ms (determined by average of 3 readings on triplicate 12-lead ECG) or has a history of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of long-QT syndrome) or current use of medications that prolong the QTcF interval.
• Any psychiatric, psychological, familial or geographical condition that, in the judgment of the PI or designee, may interfere with the treatment and follow-up, affect compliance or place the participant at high risk of treatment-related complications will be excluded.
• Blood donation or significant blood loss within 60 days prior to the first administration of CT3001.
• History of severe allergic or anaphylactic reactions, or sensitivity to the CT3001 or its constituents.
• Vaccination with a live vaccine within 4 weeks prior to the first administration of CT3001.
• Exposure to any significantly immune suppressing drug (including experimental therapies as part of a clinical study) within 5 half-lives of the product prior to the first administration of CT3001; these medications will not be permitted for the duration of treatment with CT3001.
• Use of any medications with a narrow therapeutics index that are sensitive substrates of and metabolized mainly through CYP2C8 within 5-half-lives of the products prior to the first administration of CT3001; these medications will not be permitted for the duration of treatment with CT3001.
• Use of any gastric acid reducing agents during the time period between 6 hours prior to and 2 hours after the administration of CT3001.

• Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibodies (HIV-1/-2) at Screening, unless the participant meets 1 of the following criteria:

• Has chronic hepatitis B virus (HBV) infection or virologically suppressed (VS) HBV AND has been on suppressive antiviral therapy (unless it is a prohibited medication per exclusion criteria #12) for at least 4 weeks.

• Has chronic HCV infection but has completed curative antiviral treatment (note: patients may be HCV antibody positive but must be HCV RNA negative to be eligible).

Please note: the eligibility of patients with HBV or HCV infection should be considered on a case-by-case basis by the PI in consultation with the independent Medical Monitor.

• Anything that the PI considers would jeopardize the safety of the participant, prevent complete participation in the study, or compromise interpretation of study data.

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

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