KRAS 변이 또는 증폭 진행성 고형암 환자를 위한 PT0511 임상시험¶

A Study of PT0511 in Participants With KRAS Mutated or Amplified 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	NCT07300150
상태	모집 중
단계	1상
시험 약물/중재	PT0511, Cetuximab
대상 질환	Colorectal Cancer, Pancreatic Cancer, Non-Small Cell Lung Cancer, Solid Tumor
스폰서	PAQ Therapeutics, Inc.
연령·성별	18 Years ~ 제한 없음 · ALL
목표 인원	210
시작 / 1차 완료 예정	2025-11-21 / 2028-10-18
국내 실시기관	Samsung Medical Center(Seoul), Seoul National University Bundang Hospital(Seoul), Seoul National University Hospital(Seoul), Severance Hospital, Yonsei University Health System(Seoul)
실시 국가	2개국, 기관 9곳 (South Korea, United States)
결과 게시	아니오
최근 갱신	2026-07-06

문의처 (등록된 중앙 연락처)¶

PAQ Therapeutics 781-819-2949 ClinicalTrials@paqtx.com

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

시험 개요¶

이 연구는 KRAS 변이 또는 증폭이 있는 진행성 고형암 성인 환자를 대상으로 PT0511의 안전성과 내성을 평가합니다. 단독 요법 및 대장암(Colorectal Cancer, CRC) 환자에서 cetuximab(세툭시맙)과의 병용 요법으로 진행됩니다. 최대 허용 용량(MTD) 또는 권장 제2상 용량(RP2D)을 결정하는 것이 목표입니다. 목표 인원은 210명이며 국내 기관 4곳이 참여합니다.

대상 질환은 췌장암(Pancreatic Cancer)을 포함한 KRAS 변이 또는 증폭 진행성 고형암입니다.
중재 약물은 PT0511이며, 대장암 환자 대상으로는 cetuximab과 병용합니다.
목표 환자 수는 210명이며 국내 4개 기관에서 진행 중인 제1상 임상시험입니다.

참여 조건 (AI 정리, 원문 확인 필요)¶

선정 기준: - 18세 이상의 남성 또는 여성 - 조직학적 또는 세포학적으로 확진된 진행성 또는 전이성 고형 악성종양 - CLIA 인증 기관에서 확인된 KRAS 변이 또는 야생형 KRAS 증폭 보유 - 이전 1회 이상 4회 이하의 전신 치료를 받았거나, 임상적 이점이 있는 치료에 불내성이거나 부적격한 경우 - 측정 가능한 병변 존재 (RECIST 1.1 기준) - ECOG 수행 능력 상태 0 또는 1 - 마지막 치료제 투여 후 90일까지 피임 동의. 제외 기준: - 활성 뇌 전이 또는 수막암종증 - 최근 2년 이내의 다른 악성종양 병력 (일부 완치된 암 제외) - 이전 항암 치료로 인한 미해결 독성 - 다른 중재적 임상시험 동시 참여 - 첫 투여 전 일정 기간 이내의 항암제 또는 임상시험용 약물 투여 - KRAS/RAS 분해제(degrader) 치료 전력 - 최근 6개월 이내의 유의미한 심혈관 질환 - 7일 이내 항생제가 필요한 활성 감염 - 알려진 HIV, 활성 B형 또는 C형 간염 감염 - 4주 이내의 대수술 - 투여 제품에 대한 과민반응 - 부적절한 혈액, 간, 신장 기능 수치

선정/제외 기준 원문 (영어)

Inclusion Criteria:

Men or women less than or equal to (>=) 18 years of age
Histologically or cytologically confirmed advanced or metastatic solid malignancy
Participant has a pathologically documented, locally advanced or metastatic malignancy with any KRAS mutation or wild-type (WT) KRAS amplification identified through molecular testing using a Clinical Laboratory Improvement Amendments (CLIA) certified, validated institutional or commercial test
Participant must have received at least 1 and no more than 4 prior systemic therapies or be intolerant or ineligible for available therapies known to provide clinical benefit
Measurable disease (RECIST 1.1 Criteria)
ECOG Performance Status 0 or 1
Willingness to avoid pregnancy or fathering children screening through 90 days after the last dose of study treatment

Exclusion Criteria:

Cancer History

Active brain metastasis or carcinomatous meningitis. If participants have had brain metastases resected or have received radiation therapy, they may be eligible if: (1) study treatment begins at least 4 weeks from the end of brain-specific therapy, (2) residual neurological symptoms Grade \<=2, (3) currently on stable doses of corticosteroids, and (4) pre-study brain MRI documents no new/worsening brain lesions
History of any other malignancy within the past 2 years, except:
Malignancy treated with curative intent and with no known active disease present >=2 years before enrolment and felt to be at low risk for recurrence by the investigator
Basal or squamous cell carcinoma of the skin, in situ cervical cancer, early -stage endometrial cancer that has been definitively treated, superficial bladder cancer, Gleason 6/7 treated prostate cancer, and ductal carcinoma in situ or lobular carcinoma in situ of the breast

Prior Cancer Therapy

Unresolved toxicities from prior anti-cancer therapies. Participants with prior endocrine replacement therapies are eligible for entry even if administered to treat endocrine deficiency due to the prior anti-cancer therapy
Concurrent participation in another interventional clinical study.
Treatment with anticancer medications or investigational drugs within the following intervals before the first administration of study drug:
At least 14 days for chemotherapy or targeted small-molecule therapy
At least 28 days for a prior monoclonal antibody
At least 28 days or 5 half-lives (whichever is longer) for all other investigational study drugs or devices. For drugs with very long half-lives, participants may be allowed to enroll prior to 5 half-lives at the discretion of the investigator in discussion with the medical monitor
Note: Concurrent hormonal therapy for prostate or breast cancer is allowable
Prior treatment with a KRAS/RAS degrader

Medical History

Significant cardiovascular disease within 6 months of starting study therapy
Active infection requiring antibiotics within 7 days of study treatment.
Known HIV infection with a CD4+ T-cell count \<200 cells/mcL and/or a detectable viral load per parameters of assay and/or on an anti-retroviral regimen containing a strong or moderate CYP3A4/5 inhibitor or inducer and/or on a new anti-retroviral regimen for less than 28 days prior to the initiation of study treatment
Known history of drug-induced liver injury; primary biliary cirrhosis; or ongoing extrahepatic obstruction caused by stones, cirrhosis of the liver, or portal hypertension
Major surgery within 4 weeks of the start of study therapy or postoperative complications preventing the participant from adhering to protocol assessments and procedures
Known hypersensitivity to any of the products to be administered during dosing
Any disease or disorder that, in the opinion of the investigator, may compromise the ability of the participant to provide written informed consent and/or to comply with all required study procedures

Medications

• Part 1a (Dose escalation): Use of a strong or moderate CYP3A4/5 inhibitor or inducer, Use of a strong P-gp inhibitor or inducer

Organ Function

• Participants with laboratory values indicating inadequate hematology, hepatic, or renal function

Diagnostic Assessments

Clinically significant abnormalities in rhythm, conduction, or morphology of resting ECG
Baseline QT interval corrected for heart rate using Fridericia's formula (QTcF) >=470 msec
Female participants of childbearing age with a positive urine or serum test within 7 days of study start or confirmation from Ob/Gyn that any positive bHCG test is not representative of an ongoing pregnancy
Women who are lactating/breast feeding or who plan to breastfeed while on study through 28 days after receiving the last dose of study drug
Active HBV infection. Participants with resolved infection or who are on Stable antiviral therapy are eligible
Active HCV infection. Participants who have completed definitive antiviral therapy with post treatment confirmation of eradication are eligible

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

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