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A Clinical Study Evaluating a New Treatment Strategy for Patients With Advanced Pancreatic Cancer Who Have Not Received Prior Treatment for Advanced Disease. (NUMANTIA-2)

2026년 5월 11일 업데이트: Nelum Corp

A Randomized Phase II Study of Priming Treatment With the Hedgehog Inhibitor NLM-001 Prior to Gemcitabine/Nab-Paclitaxel (GNab-P) plusBotensilimab and Balstilimab (Bot/Bal) Versus GNab-P in Patients With Previously Untreated Advanced Pancreatic Cancer (NUMANTIA-2)

Phase II, open label, randomized multicenter study to evaluate efficacy and safety of study treatment in previously untreated patients with advanced pancreatic cancer. Patients will receive study treatment for a maximum of 24 months or until progression disease or until unacceptable toxicity. In the experimental arm, patients who discontinue chemotherapy for reasons other than disease progression may continue receiving the remaining study drugs (NLM-001, botensilimab and balstilimab) up to a maximum of 24 months, according to schedule.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

Participants will be centrally randomized 1:1 to one of the study arms. Randomization will be stratified according to:

  1. ECOG Performance Status (0 vs 1)
  2. Presence of liver metastases (yes vs no)

연구 유형

중재적

등록 (추정된)

40

단계

  • 2 단계

연락처 및 위치

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

연구 장소

  • 스페인
    • Aragon
      • Zaragoza, Aragon, 스페인
        • Hospital Universitario Miguel Servet
        • 연락하다:
          • Roberto Pazo, MD
        • 수석 연구원:
          • Roberto Pozo, MD
    • Barcelona
      • Barcelona, Barcelona, 스페인
        • Hospital Clinic Barcelona
        • 수석 연구원:
          • Teresa Macarulla, MD
        • 연락하다:
          • Teresa Macarulla, MD
    • Cantabria
      • Santander, Cantabria, 스페인
        • Hospital Universitario Marqués de Valdecilla
        • 수석 연구원:
          • Fernando Rivera, MD
        • 연락하다:
          • Fernando Rivera, MD
    • Gipuzkoa
      • San Sebastián, Gipuzkoa, 스페인
        • Hospital Universitario DE Donostia
        • 연락하다:
          • Aitziber Gil-Negrete, MD
        • 수석 연구원:
          • Aitziber Gil-Negrete, MD
    • La Coruña
      • Santiago de Compostela, La Coruña, 스페인
        • Complexo Hospitalario Universitario De Santiago
        • 연락하다:
          • Elena María Brozos, MD
        • 수석 연구원:
          • Elena María Brozos, MD
    • Málaga
      • Málaga, Málaga, 스페인
        • Hospital Universitario Virgen de la Victoria
        • 연락하다:
          • Laura Medina, MD
        • 수석 연구원:
          • Laura Medina, MD

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

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. Investigators must ensure that patients are able to understand the requirements of the study and provide informed consent.
  2. Age ≥18 years.
  3. Histological or cytological diagnosis of pancreatic adenocarcinoma.
  4. Stage IV disease.
  5. No prior treatment for advanced disease. Patients who have received chemotherapy for localized disease are eligible if they progress within six months from the last chemotherapy treatment.
  6. Measurable disease per iRECIST 1.1 as determined by the investigator.
  7. ECOG (Eastern Cooperative Oncology Group) PS 0-1.

  8. Sufficient hematopoietic, renal and liver function as defined as:

    • Neutrophil count ≥ 1.5 x 10^9 / L
    • Platelet count ≥ 100 x 10^9 / L
    • Bilirubin ≤ 1.5 x ULN (upper limit of normal)
    • AST and / or ALT ≤2.5 x ULN or ≤5 for patients with liver disease
    • Serum creatinine ≤ 1.5 x ULN
  9. Tumor lesion amenable to safe repeated tumor biopsy.
  10. Women of child-bearing age and men who wish to participate in the study must agree to use appropriate contraceptive methods from the signing of informed consent until 6 months for women and 3 months for men after discontinuation of the study drug o Adequate contraception includes abstinence, oral contraceptives, transdermal patches, and injections that prolong release of a progestogen (starting at least 4 weeks prior to the administration of the investigational drug), condom or female condom (diaphragm or condom / vaginal) plus spermicide, intrauterine device (IUD), implant or a vaginal ring (placed at least 4 weeks prior to administration of investigational drug) or male partner sterilization (vasectomy with documentation of azoospermia) before the inclusion of the woman in the trial if the male is the only sex partner of the woman (see appendix G).

Exclusion Criteria:

  1. Active or uncontrolled infectious disease or serious medical condition that may interfere with the patient's eligibility or treatment.
  2. History of psychiatric condition that would compromise the patient's ability to understand or comply with the requirements of the protocol, or the ability to provide informed consent.
  3. Concurrent antineoplastic therapy.
  4. Prior chemotherapy or chemo-radiation therapy for advanced pancreatic cancer.
  5. Prior anti-PD-(L)1 or anti-CTLA-4 as prior therapy(ies).
  6. Pregnant or lactating women.
  7. History of allergic reactions attributed to compounds of similar chemical structure or similar biological study drug composition.
  8. History of life-threatening serious adverse events to Gemcitabine or Nab-Paclitaxel.
  9. Patients requiring or being treated with potent CYP3A4 inhibitors and inducers.
  10. Other active malignancies undergoing or requiring systemic treatment.
  11. History of interstitial lung disease.
  12. Subjects with history or presence of a known clotting disorder or difficulty achieving haemostasis will be excluded.

  13. Primary or secondary immunodeficiency, including immunosuppressive disease or autoimmune disease (including autoimmune endocrinopathies).

    Note: Subjects with type 1 diabetes, vitiligo, psoriasis, hypo-, or hyperthyroid disease not requiring immunosuppressive treatment are eligible. Subjects with Type 2 diabetes mellitus are allowed.

  14. Subjects with a known history of human immunodeficiency virus 1 and 2, human T lymphotropic virus 1.

  15. Prior treatment with anticancer therapies, immunosuppressive agents, corticosteroids, radiation, investigational drugs or vaccines within the following time intervals before the first dose of study treatment (C1D1):

    (i) Cytotoxic chemotherapy: within 3 weeks prior to C1D1. (ii) Monoclonal antibodies, antibody-drug conjugates or radioimmunoconjugates: within 4 weeks or 5 half-lives, whichever is shorter.

    (iii) Small-molecule targeted therapies, including tyrosine kinase inhibitors: within 2 weeks or 5 half-lives, whichever is shorter.

    (iv) Any other anti-neoplastic therapy (including experimental agents): within 3 weeks, except:

    • Investigational drugs or devices must not have been administered within 21 days or 5 half-lives (whichever is longer).

    • For investigational agents with long half-lives (>5 days), earlier enrolment requires approval by the medical monitor.

      (v) Radiotherapy: - A 1-week washout is permitted for palliative radiation to non-CNS lesions, with medical monitor approval.

    • Patients must not have experienced radiation pneumonitis or be receiving chronic corticosteroids for this condition.

    (vi) Corticosteroids: - No systemic corticosteroids within 7 days, except:

    • inhaled or topical corticosteroids,
    • corticosteroid premedication for contrast allergy,
    • physiologic replacement doses, with medical monitor approval. (vii) Immunosuppressive therapies: - No immunosuppressive treatment within 7 days, except for the permitted corticosteroid uses listed above.

    (viii) SARS-CoV-2 vaccination:

    • No COVID-19 vaccine within 7 days before randomization.
    • When feasible, multi-dose vaccine series should be completed prior to randomization.

  16. Has not recovered to grade ≤1 from toxic effects of prior therapy and/or complications from prior surgical intervention before starting therapy.

    Note: Subjects with grade ≤2 neuropathy and alopecia are an exception and may enroll.

  17. History or presence of an abnormal ECG that, in the investigator's opinion, is clinically meaningful.

  18. Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months of study enrollment, unstable angina, congestive heart failure (New York Heart Association class ≥ III), or serious uncontrolled cardiac arrhythmia requiring medication.

    a. QTcF (QT interval corrected using Fridericia's formula) of > 480 ms.

  19. Concurrent participation in other investigational drug trials.

  20. Known central nervous system (CNS) involvement as follows:

    • Untreated CNS metastases.
    • Leptomeningeal metastases. Note: Patients may be eligible if CNS metastases have been treated and patients have neurologically returned to baseline (except for residual signs and symptoms related to the CNS treatment).
  21. Known to be positive for hepatitis B virus (HBV) surface antigen, or any other positive test for HBV indicating acute or chronic infection. Participants who are receiving or who have received anti-HBV therapy and have undetectable HBV DNA for at least 6 months prior to study enrollment are eligible. Serological testing for HBV at screening is not required.
  22. Known active hepatitis C virus (HCV) as determined by positive serology and confirmed by polymerase chain reaction (PCR). Participants on or who have received antiretroviral therapy are eligible provided they are virus-free by PCR for at least 6 months prior to study enrollment. Serological testing for HCV at screening is not required.

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: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Control Arm
Gemcitabine (G): 1,000 mg/m2 Nab-Paclitaxel (Nab-P): 125 mg/m2
의약품: Gemcitabine (1000 mg/m2)
Gemcitabine 1,000 mg / m2 IV administered on days 1, 8 and 15 in cycles of 28 days.
의약품: Nab-paclitaxel (Abraxane)
Nab-P 125 mg / m2 IV administered on days 1, 8 and 15 in cycles of 28 days.
실험적: Experimental Arm
NLM-001: 800 mg/day Gemcitabine (G): 1,000 mg/m2 Nab-Paclitaxel (Nab-P): 125 mg/m2 Botensilimab (Bot, CTLA-4 inhibitor): 75 mg Balstilimab (Bal, PD-1 inhibitor): 240 mg
의약품: Gemcitabine (1000 mg/m2)
Gemcitabine 1,000 mg / m2 IV administered on days 1, 8 and 15 in cycles of 28 days.
의약품: Nab-paclitaxel (Abraxane)
Nab-P 125 mg / m2 IV administered on days 1, 8 and 15 in cycles of 28 days.
의약품: NLM-001
NLM-001: 800 mg/day, p.o, once daily (4 tablets of 200 mg) days -4 to -1 and 10-13 of each cycle.
의약품: Botensilimab
Botensilimab: 75 mg every 6 weeks for 4 administrations, from D1C1.
의약품: Balstililmab
Balstilimab: 240 mg IV Day 1 and Day 15 of each 28-day cycle.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
To evaluate the response rate in each of the study arms, assessed according to iRECIST criteria, including the confirmation of progression to distinguish true progression from potential pseudoprogression.
기간: 12 months
Objective Response Rate (ORR): Complete Response (CR) + Partial Response (PR), according to iRECIST 1.1 criteria, according to investigator criteria. Suspected progression (including possible pseudoprogression due to immune-related effects or new lesions) must be confirmed with repeat imaging performed 4-8 weeks after the initial assessment before considering the patient as having true disease progression.
12 months

2차 결과 측정

결과 측정
측정값 설명
기간
To evaluate safety profile and tolerability of study treatment according to NCI-CTCAE v 5.0 criteria.
기간: 12 months
Safety profile will be assessed according to NCI-CTCAE v 5.0 criteria. The number of patients experiencing each AE will be summarized by CTCAE grade.
12 months
To evaluate treatment efficacy according to progression free survival (PFS)
기간: 12 months
Progression Free Survival (PFS): PFS is defined as the time in months from the patient's randomization until patient progression according to iRECIST 1.1 criteria or death.
12 months
To evaluate treatment efficacy according to 6 months PFS
기간: 6 months
Progression Free Survival (PFS): PFS is defined as the time in months from the patient's randomization until patient progression according to iRECIST 1.1 criteria or death.
6 months
To evaluate treatment efficacy according todisease control rate (DCR)
기간: 12 months
Disease Control Rate (DCR): Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) evaluated by iRECIST 1.1 criteria according to investigator criteria.
12 months
To evaluate treatment efficacy according to duration of response (DoR)
기간: 12 months
Duration of Response (DoR): DoR is defined as the time in months from the date of first documented objective response (complete response [CR] or partial response [PR], whichever is first) until the date of first documented disease progression or death from any cause, whichever occurs first.
12 months
To evaluate treatment efficacy according to duration of clinical benefit (DoCB)
기간: 12 months
Duration of Clinical Benefit (DoCB): DoCB is defined, for subjects achieving clinical benefit (complete response [CR], partial response [PR], or stable disease [SD] per iRECIST v1.1), as the time from the date of first documented evidence of clinical benefit (CR, PR, or SD) until the date of first documented radiographic disease progression or death from any cause, whichever occurs first.
12 months
To evaluate treatment efficacy according to overall survival.
기간: 12 months
Overall Survival (OS): OS is defined as the time in months from the patient's randomization until death.
12 months
To evaluate CA 19.9 levels during study treatment (Decrease > 50%)
기간: 12 months
Decrease in CA 19.9 levels > 50%. Responses based on levels of the tumor marker CA 19.9 will be calculated as the maximum percentage of change with respect to baseline in those patients with a baseline higher than 1.25 times the upper limit of normal in the local laboratory of each center.
12 months
To evaluate CA 19.9 levels during study treatment (Decrease > 75%)
기간: 12 months
Decrease in CA 19.9 levels > 75%. Responses based on levels of the tumor marker CA 19.9 will be calculated as the maximum percentage of change with respect to baseline in those patients with a baseline higher than 1.25 times the upper limit of normal in the local laboratory of each center.
12 months
To evaluate CA 19.9 levels during study treatment (Decrease > 90%).
기간: 12 months
Decrease in CA 19.9 levels > 90%. Responses based on levels of the tumor marker CA 19.9 will be calculated as the maximum percentage of change with respect to baseline in those patients with a baseline higher than 1.25 times the upper limit of normal in the local laboratory of each center.
12 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Nelum Corp

협력자

Apices Soluciones S.L.
PH Research, S.L.

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 (추정된)

2026년 7월 15일

기본 완료 (추정된)

2029년 2월 28일

연구 완료 (추정된)

2029년 2월 28일

연구 등록 날짜

최초 제출

2026년 5월 5일

QC 기준을 충족하는 최초 제출

2026년 5월 5일

처음 게시됨 (실제)

2026년 5월 11일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 11일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • NLM-2026-02 / NUMANTIA-2
  • 2026-525796-90-00 (씨티스)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

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. .

진행성 췌장암에 대한 임상 시험

Gemcitabine (1000 mg/m2)에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Zimbabwe

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다