이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

PROC 또는 r/r 선암종 NSCLC 환자에서 NaPi2b ADC TUB-040의 안전성, PK 및 효능을 조사하기 위한 FiH 연구 (NAPISTAR1-01)

2026년 10월 30일 업데이트: Gilead Sciences

백금 내성 고급 난소암(PROC) 또는 r/r 환자를 대상으로 NaPi2b ADC TUB-040의 안전성, 내약성, PK 및 효능을 조사하기 위한 최초의 인간 투여량 증가 및 최적화 1/2a상 연구 선암종 비소세포폐암(NSCLC)

The goal of this clinical study is to learn more about the study drug, TUB-040, including its safety, tolerability, pharmacokinetics, and preliminary efficacy, and to determine the best dose of TUB-040 in participants with ovarian cancer or non-small cell lung cancer (NSCLC).

The primary objectives of this study are:

Phase 1: To determine the safety and tolerability of TUB-040 and determine the maximum tolerated dose (MTD) or the identified dose for optimization (IDO).

Phase 2a: To assess safety of TUB-040, the preliminary efficacy of TUB-040, and to identify the recommended phase II dose (RP2D) for further development of TUB-040 .

Phase 2b: To determine the efficacy of TUB-040 in patients with PROC.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

334

단계

  • 2 단계
  • 1단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 독일
      • Berlin, 독일, 13353
        • 모병
        • Charité- Universitaetsmedizin Berlin
      • Cologne, 독일, 50937
        • 모병
        • University Hospital of Cologne
  • 루마니아
      • Cluj-Napoca, 루마니아, 40015
        • 모병
        • ARENSIA Exploratory Medicine, LLC
  • 미국
    • Alabama
      • Birmingham, Alabama, 미국, 35294
        • 모병
        • University of Alabama at Birmingham
    • Georgia
      • Atlanta, Georgia, 미국, 30322
        • 모병
        • Winship Cancer Institute Emory University
    • Massachusetts
      • Boston, Massachusetts, 미국, 02215
        • 모병
        • Dana Farber Cancer Institute (DFCI)
    • New Jersey
      • East Brunswick, New Jersey, 미국, 08816
        • 모병
        • START New Jersey (Astera Cancer Center)
    • New York
      • New York, New York, 미국, 10011
        • 모병
        • Mount Sinai
    • Ohio
      • Cincinnati, Ohio, 미국, 45219
        • 모병
        • The Christ Hospital Physicians - Mt. Auburn
      • Columbus, Ohio, 미국, 43210
        • 모병
        • Ohio State University CRS
    • Oklahoma
      • Oklahoma City, Oklahoma, 미국, 73104
        • 모병
        • Stephenson Cancer Center
    • Oregon
      • Medford, Oregon, 미국, 97504
        • 모병
        • Asante Rogue Region al Medical Center
    • Texas
      • Fort Worth, Texas, 미국, 76104
        • 모병
        • START Dallas Fort Worth
      • Irving, Texas, 미국, 75039
        • 모병
        • NEXT Oncology Dallas
    • Utah
      • West Valley City, Utah, 미국, 84119
        • 모병
        • START Mountain Region
    • Virginia
      • Fairfax, Virginia, 미국, 22031
        • 모병
        • NEXT Virginia
  • 벨기에
      • Leuven, 벨기에, 3000
        • 모병
        • UZ Leuven - PPDS
  • 스페인
      • Madrid, 스페인, 28027
        • 모병
        • Clínica Universidad de Navarra - Madrid
      • Madrid, 스페인, 28223
        • 모병
        • NEXT Madrid, University Hospital Quironsalud Madrid
  • 영국
      • London, 영국, SE1 9RT
        • 모집하지 않고 적극적으로
        • Guy's Hospital
  • 우크라이나
      • Kyiv, 우크라이나, 01135
        • 모집하지 않고 적극적으로
        • ARENSIA Exploratory Medicine, LLC

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Key Inclusion Criteria (for all phases)

  1. Male or non-pregnant, non-breastfeeding female, age 18 years or older at the date of consent.
  2. Disease not amenable to curative intent treatment.
  3. Individuals have exhausted the standard of care treatment (SoC) with expected survival benefit and are not denied SoC with expected survival benefit by participating in the trial.
  4. Individuals with previous systemic topoisomerase I inhibitor treatment (e.g., Topotecan) are allowed in the study.
  5. Radiologically measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the INV.
  6. Eastern Cooperative Oncology Group (ECOG) 0-1.
  7. Have a life expectancy of more than 12 weeks for disease-related mortality, as evaluated by the INV.
  8. Individuals must be willing to sign an archival tissue release form for research purposes and determination of biomarker expression.
  9. Individuals must be willing to undergo a non-contrast high resolution computed tomography (HRCT) of the thorax scan and pulmonary function testing (PFT) at screening.
  10. Adequate organ function
  11. Resolution of all acute toxic effects of prior therapy or surgical procedures to ≤grade 1 (except alopecia, hyperpigmentation, or discoloration (incl. vitiligo) of the skin and nails, stable immune-related toxicity such as hypothyroidism on hormone replacement, adrenal insufficiency on ≤10 mg daily prednisone [or equivalent], chronic grade 2 peripheral sensory neuropathy after prior taxane therapy or anticancer treatment such as but not limited to immune oncology therapy (IOs)).
  12. Individuals of childbearing potential (FCBP) who are sexually active with a non-sterilized partner must use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of individuals assigned female at birth.
  13. In the opinion of the investigator, the individual must be able to understand, give written informed consent, and comply with all study-related procedures, medication use, and evaluations.
  14. The individual must not have a history of non-compliance with medical regimens or be considered potentially unreliable and/or uncooperative.
  15. The individual must be willing to sign and date the informed consent form (ICF)

Key Exclusion Criteria (for all phases)

  1. The individual is pregnant, lactating or breastfeeding or has a positive serum pregnancy test during the screening period.

  2. History of hypersensitivity to exatecan or excipients of the TUB-040 formulation.

  3. Individuals are not allowed to participate in interventional clinical studies either concurrently or within the previous 28 days or within 5 half-lives of any investigational pharmacologic agents or imaging materials, including dyes, investigational surgical techniques, or devices.

  4. Individuals with spinal cord compression or active central nervous system disease, and/or carcinomatous meningitis.

  5. Prior radiotherapy <2 weeks from trial inclusion.

  6. Major surgery within 21 days prior to signing the ICF, unless the individual is recovered at that time.

  7. Has a history of non-infectious interstitial lung disease/pneumonitis (ILD)/pneumonitis/radiation pneumonitis that required steroids or has current ILD/pneumonitis.

  8. Has an oxygen saturation of <93% on room air at rest.

  9. Has a QTcF >470 ms

  10. History of nephrotic syndrome

  11. Active corneal disease, or history of corneal disease within 12 months prior to enrollment.

  12. Active, uncontrolled or severe impairment of the urogenital, renal, hepatobiliary, cardiovascular, gastrointestinal, neurologic, or hematopoietic systems which, in the opinion of the investigator, would predispose the individual to the development of complications from the administration of protocol therapy.

  13. History of another malignancy with ongoing treatment or not yet free from disease for 2 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a similar expected curative outcome.

  14. Documented other concurrent non-malignant comorbidities such as unstable or uncontrolled pectoral angina, myocardial infarction during the last 6 months, valvular heart disease that requires treatment, acute myocarditis, or congestive heart failure (CHF) (New York Heart Association III or IV).

  15. Any anti-tumor chemotherapy, systemic anti-cancer therapy, radiotherapy (except for local radiation therapy of lesions that may cause imminent complications), hormonal therapy, immunotherapy, or corticoid therapy.

  16. Concurrent use of strong inhibitors or strong inducers of CYP3A4

  17. Live vaccines within 30 days prior to study entry.

  18. Individuals with acute or chronic infections such as:

    1. Individuals who are HBsAg positive are eligible if they have received Hepatitis B virus (HBV) anti-viral therapy for at least 4 weeks and have an undetectable HBV viral load prior to randomization.
    2. Individuals with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
    3. HIV infected individuals must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease
    4. Any other known unresolved and active bacterial, viral, fungal, mycobacterial, or other infection at screening.
    5. History of severe and recurrent infections per INV judgment.
    6. History of progressive multifocal leukoencephalopathy

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위화되지 않음
  • 중재 모델: 순차적 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Phase 1: Cohort 1: Dose Escalation in Platinum Resistant Ovarian Cancer (PROC)

Participants will receive escalating doses of TUB-040 every 3 weeks until the disease progresses or the patient has to stop due to side effects.
의약품: TUB-040

Administered intravenous (IV) on day 1 of each 21-day treatment cycle
실험적: Phase 1: Cohort 2: Dose Escalation in R/R NSCLC of the adenocarcinoma subtype

Participants will receive escalating doses of TUB-040 every 3 weeks until the disease progresses or the patient has to stop due to side effects.
의약품: TUB-040

Administered intravenous (IV) on day 1 of each 21-day treatment cycle
실험적: Phase 1: Cohort 3: PROC, Combination with Bevacizumab (BEV)

Participants will receive escalating doses of TUB-040 combined with BEV every 3 weeks until the disease progresses or the patient has to stop due to side effects.
의약품: Bevacizumab

Administered IV

다른 이름들:
  • 베브
의약품: TUB-040

Administered intravenous (IV) on day 1 of each 21-day treatment cycle
실험적: Phase 2a: Dose Optimization in PROC

Participants will receive two different dose levels of TUB-040 every 3 weeks until the disease progresses or the patient has to stop due to side effects.
의약품: TUB-040

Administered intravenous (IV) on day 1 of each 21-day treatment cycle
실험적: Phase 2b: Dose Expansion in PROC

Patients will receive TUB-040 at the safe dose established during dose escalation until disease progression or unacceptable toxicity.
의약품: TUB-040

Administered intravenous (IV) on day 1 of each 21-day treatment cycle

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Phase 1 and 2a: Percentage of Participants Experiencing Treatment-Emergent Adverse Event (TEAEs)
기간: First dose date up to 30 days post last dose (Up to 3 years)
First dose date up to 30 days post last dose (Up to 3 years)
Phase 1: Percentage of Participants Experiencing any Dose-limiting Toxicities (DLTs)
기간: First dose up to 21 days
First dose up to 21 days
Phase 2a & 2b: Overall Response Rate (ORR) by Blinded Independent Central Review (BICR)
기간: Up to 3 years

ORR is defined as the percentage of participants who have achieved complete response (CR) or partial response (PR), as assessed by BICR.
Up to 3 years

2차 결과 측정

결과 측정
측정값 설명
기간
Phase 1: Percentage of Participants Experiencing Serious Adverse Events (SAEs)
기간: First dose date up to 30 days post last dose (Up to 3 years)
First dose date up to 30 days post last dose (Up to 3 years)
Phase 1, 2a & 2b: Percentage of Participants Developing anti-TUB-040 antibodies and semiquantitative titer assessments
기간: From enrollment until 30 days after last study drug
From enrollment until 30 days after last study drug
Phase 2a & 2b: Percentage of Participants Experiencing TEAEs
기간: First dose date up to 30 days post last dose date (Up to 3 years)
First dose date up to 30 days post last dose date (Up to 3 years)
Phase 2a & 2b: Duration of Response (DOR) by BICR
기간: Up to 3 years

DOR is defined as the interval from the first documentation of CR or PR until the date of first documented disease progression or death, whichever comes first, as assessed by BICR.
Up to 3 years
Phase 1, 2a & 2b: ORR by INV
기간: Up to 3 years

ORR is defined as the percentage of participants who have achieved complete response (CR) or partial response (PR), as assessed by Investigator (INV).
Up to 3 years
Phase 1, 2a & 2b: DOR by INV
기간: Up to 3 years

DOR is defined as the interval from the first documentation of CR or PR until the date of first documented disease progression or death, whichever comes first, as assessed by INV.
Up to 3 years
Phase 1, 2a & 2b: Progression-Free Survival (PFS) by INV
기간: Up to 3 years

PFS is defined as the time from first dose date until disease progression or death from any cause, whichever comes first, as assessed by INV.
Up to 3 years
Phase 1, 2a & 2b: Disease Control Rate (DCR) by INV
기간: Up to 3 years

DCR is defined as the percentage of participants with a confirmed CR, PR, or stable disease, as assessed by INV.
Up to 3 years
Phase 2a & 2b: Progression-Free Survival (PFS) by BICR
기간: Up to 3 years

PFS is defined as the time from first dose date until disease progression or death from any cause, whichever comes first, as assessed by BICR.
Up to 3 years
Phase 2a & 2b: Disease Control Rate (DCR) by BICR
기간: Up to 3 years

DCR is defined as the percentage of participants with a confirmed CR, PR, or stable disease, as assessed by BICR.
Up to 3 years
Phase 1, 2a & 2b: Percentage of Participants Experiencing Grade ≥3 Lab Abnormalities
기간: Up to 3 years
Up to 3 years
Phase 1 & 2a: Pharmacokinetic (PK) Parameter of TUB-040, total Monoclonal Antibody (mAb), and Free Exatecan: Cmax
기간: Up to 3 years

Cmax is defined as the maximum observed drug concentration.
Up to 3 years
Phase 1 & 2a: PK Parameter of TUB-040, Total mAb, and Free Exatecan: Cmin
기간: Up to 3 years

The concentration of TUB-040 (conjugated ADC), total mAb, and free payload (Cmin will be derived).
Up to 3 years
Phase 1 & 2a: PK Parameter TUB-040, Total mAb, and Free Exatecan: Tmax
기간: Up to 3 years

Tmax is defined as the time (observed time point) of Cmax.
Up to 3 years
Phase 1 & 2a: PK Parameter TUB-040, Total mAb, and Free Exatecan: Area Under Curve (AUC)
기간: Up to 3 years

AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption.
Up to 3 years
Phase 1 & 2a: PK Parameter TUB-040, Total mAb, and Free Exatecan: Half life (t1/2)
기간: Up to 3 years

t1/2 is defined as the terminal elimination half-life at steady state.
Up to 3 years
Phase 2a & 2b: Overall Survival (OS)
기간: Up to 3 years

OS is defined as the length of time from first dose until the date of death from any cause.
Up to 3 years
Phase 2a & 2b: Cancer Antigen (CA)-125 response according to Gynecological Cancer InterGroup (GCIG)
기간: Up to 3 years
Up to 3 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Gilead Sciences

수사관

  • 연구 책임자: Gilead Study Director, Gilead Sciences

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2024년 6월 12일

기본 완료 (추정된)

2027년 12월 1일

연구 완료 (추정된)

2027년 12월 1일

연구 등록 날짜

최초 제출

2024년 2월 6일

QC 기준을 충족하는 최초 제출

2024년 3월 6일

처음 게시됨 (실제)

2024년 3월 12일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 11월 3일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 10월 30일

마지막으로 확인됨

2026년 10월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NAPISTAR 1-01
  • 2024-511074-80 (EudraCT 번호)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

예

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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