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

전이성 고형 종양이 있는 피험자를 대상으로 한 SLV 154의 1상 용량 증량 연구

2026년 9월 18일 업데이트: Solve Therapeutics

This is a Phase 1 study comprising a Phase 1a dose-escalation portion and a Phase 1b expansion portion evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-154 across a range of dose levels when administered to subjects with advanced solid tumors.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

A Bayesian optimal interval (BOIN) design with a target dose-limiting toxicity (DLT) rate for the maximum tolerated dose (MTD) of 27% and an estimated maximum sample size of ~70 subjects will be used to guide the dose escalation and determine the recommended dosing regimen (RDR) of SLV-154. Once the initial RDR is established in the Phase 1a portion of this study, further development in the Phase 1b expansion portion of this study will be considered in patients with specific cancers. In the Phase 1b part of this study, enrollment of each tumor-specific cohort will be performed using a Simon 2-stage optimal design.

SLV-154 will be administered intravenously (IV) in repeated 3-week cycles. Treatment will continue until progressive disease or discontinuation.

연구 유형

중재적

등록 (추정된)

250

단계

  • 1단계

연락처 및 위치

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

연구 연락처

연구 연락처 백업

연구 장소

  • 미국
    • California
      • Newport Beach, California, 미국, 92663
        • 모병
        • Hoag Memorial Hospital Presbyterian
        • 연락하다:
    • Missouri
      • St Louis, Missouri, 미국, 63110
        • 모병
        • Washington University
        • 연락하다:
    • New Jersey
      • East Brunswick, New Jersey, 미국, 08816
    • New York
      • New York, New York, 미국, 10065
        • 모병
        • Memorial Sloan Kettering Cancer Center
        • 연락하다:
    • Ohio
      • Cleveland, Ohio, 미국, 44106
        • 모병
        • University Hospitals Cleveland Medical Center
        • 연락하다:
      • Columbus, Ohio, 미국, 43210
        • 모병
        • The James Outpatient Care West Center
        • 연락하다:
    • Pennsylvania
      • Philadelphia, Pennsylvania, 미국, 19111
    • Texas
      • Houston, Texas, 미국, 77030
        • 모병
        • MD Anderson Cancer Center
        • 연락하다:
      • Houston, Texas, 미국, 77030
      • San Antonio, Texas, 미국, 78229
        • 모병
        • Mays Cancer Center; University of Texas Health San Antonio
        • 수석 연구원:
          • Daruka Mahadevan
        • 연락하다:
    • Washington
      • Seattle, Washington, 미국, 98109
        • 모병
        • University of Washington / Fred Hutchinson Cancer Center
        • 연락하다:
      • Tacoma, Washington, 미국, 98405
        • 모병
        • Northwest Medical Specialties, PLLC
        • 연락하다:
        • 연락하다:

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

12년 이상 (어린이, 성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Men or women (as appropriate for cancer type) of age ≥12 years.
  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  3. Histologically or cytologically confirmed diagnosis of advanced cancer as documented in medical records.
  4. Presence of metastatic or recurrent locally advanced cancer.
  5. Presence of radiographically measurable disease.
  6. Prior receipt of one or more commercially available therapies that are indicated within product labelling or recommended under current guidelines as appropriate treatment for the subject's cancer (unless evolving data support application of SLV-154 in previously untreated subjects with high unmet medical need and inadequate and/or poorly tolerated treatment options).
  7. Availability of tumor tissue from a fresh tumor biopsy obtained by a core needle, excisional, or incisional biopsy; or punch biopsy (for cutaneous disease); or archival tumor sample from a previous biopsy.
  8. Availability of computed tomography (CT) or magnetic resonance imaging (MRI) of chest, abdomen, and pelvis, and/or fluorodeoxyglucose (FDG) positron emission tomography (PET)/CT (if appropriate for tumor type) (with PET from base of the skull to mid-thigh, if performed) within 35 days before study drug administration.
  9. Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, targeted therapy, immunotherapy, or investigational therapy) for the treatment of cancer ≥1 week before the start of study drug administration.
  10. Adequate hematological profile.
  11. Adequate coagulation profile.
  12. Adequate hepatic profile.
  13. Adequate renal function.
  14. Negative viral serology or adequate therapy for human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV) infection.
  15. For female subjects of childbearing potential, a negative serum pregnancy test.
  16. For female subjects of childbearing potential, willingness to use a protocol-recommended method of contraception from the start of the screening period until ≥6 months after the final dose of study therapy.
  17. For male subjects who can father a child and are having intercourse with females of childbearing potential who are not using adequate contraception, willingness to use a protocol-recommended method of contraception from the start of study therapy until ≥6 months after the final dose of study therapy and to refrain from sperm donation from the start of study therapy until ≥12 months after administration of the final dose of study therapy.
  18. Willingness and ability of the subject to comply with scheduled visits, the drug administration plan, protocol-specified laboratory tests, other study procedures (including required tumor biopsy/aspirations and/or radiographic studies), and study restrictions.
  19. Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.

Exclusion Criteria:

  1. Unstable malignancy involving the central nervous system.
  2. Presence of another cancer with disease manifestations or therapy that could adversely affect subject safety or longevity, create the potential for drug-drug interactions, or compromise the interpretation of study results.
  3. Uncontrolled ongoing systemic bacterial, fungal, or viral infection (including upper respiratory tract infection) at the time of start of study therapy.
  4. Significant cardiovascular event or comorbidity.
  5. Significant screening ECG abnormalities.
  6. Pregnancy or breastfeeding.
  7. Major surgery within 3 weeks before the start of study therapy.
  8. Use of a strong inhibitor or inducer of CYP3A4 or CYP1A2.
  9. Concurrent participation in another therapeutic or imaging clinical trial.
  10. Other conditions likely to interfere with a subject's ability to participate in the study.

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: Dose Level 1

0.75 mg/kg
의약품: SLV-154

SLV-154
실험적: Dose Level 2

1.5 mg/kg
의약품: SLV-154

SLV-154
실험적: Dose Level 3

3.0 mg/kg
의약품: SLV-154

SLV-154
실험적: Dose Level 4

4.0 mg/kg
의약품: SLV-154

SLV-154
실험적: Dose Level 5

5.0 mg/kg
의약품: SLV-154

SLV-154
실험적: Dose Level 6

6.5 mg/kg
의약품: SLV-154

SLV-154

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Phase 1a: MTD and/or RDR
기간: Through the duration of treatment, up to approximately 18 months

Determination of the MTD (maximum tolerated dose) and/or RDR (recommended dosing regimen) for SLV-154.
Through the duration of treatment, up to approximately 18 months
Phase 1b: Objective response rate (ORR)
기간: Through the duration of treatment, up to approximately 18 months

ORR assessed by Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 criteria and defined as the percentage of participants with confirmed complete response (CR) or confirmed partial response (PR).
Through the duration of treatment, up to approximately 18 months

2차 결과 측정

결과 측정
측정값 설명
기간
SLV-154 administration
기간: Through the duration of treatment, up to approximately 18 months

SLV-154 drug administration as assessed by prescribing records
Through the duration of treatment, up to approximately 18 months
SLV-154 Safety
기간: Through the duration of treatment, up to approximately 18 months

Collection of type, frequency, severity, timing of onset, duration, and relationship to study drug of any treatment-emergent adverse events (TEAEs); laboratory abnormalities; vital sign/oxygen saturation abnormalities; adverse electrocardiogram (ECG) findings; DLTs; serious adverse events (SAEs); adverse events of special interest (AESIs); or adverse events (AEs) leading to interruption, modification, or discontinuation of study drug administration.
Through the duration of treatment, up to approximately 18 months
Evaluation of use of concomitant medications
기간: Through the duration of treatment, up to approximately 18 months

Type, frequency, and timing of use of supportive care and other concomitant medications
Through the duration of treatment, up to approximately 18 months
SLV-154 Pharmacokinetics
기간: Varying timepoints through the duration of treatment, up to approximately 18 months

Evaluation of the pharmacokinetic profile of SLV-154
Varying timepoints through the duration of treatment, up to approximately 18 months
Immunogenicity
기간: Varying timepoints through the duration of treatment, up to approximately 18 months

Measurement of changes in titers of circulating SLV 154-reactive antibodies (as assessed using immunoassay methods)
Varying timepoints through the duration of treatment, up to approximately 18 months
Time to Response (TTR)
기간: Up to approximately 36 months

TTR: interval from the start of study drug administration to the first documentation of objective tumor regression
Up to approximately 36 months
Duration of Response (DOR)
기간: Up to approximately 36 months

DOR: interval from the first documentation of objective tumor regression to the earlier of the first documentation of disease progression or death from any cause
Up to approximately 36 months
4-month progression-free survival (PFS4)
기간: Up to approximately 36 months

PFS4: proportion of subjects who are alive and have not experienced disease progression at 4 months after the start of study drug administration
Up to approximately 36 months
6-month progression-free survival (PFS6)
기간: Up to approximately 36 months

PFS6: proportion of subjects who are alive and have not experienced disease progression at 6 months after the start of study drug administration
Up to approximately 36 months
Time to treatment failure (TTF)
기간: Up to approximately 36 months

TTF: interval from the start of study drug administration to the earliest of the first documentation of disease progression, the permanent cessation of study drug due to an AE, or death from any cause
Up to approximately 36 months
Overall survival (OS)
기간: Up to approximately 36 months

OS: interval from the start of study drug administration to death from any cause
Up to approximately 36 months
Disease benefit ratio (DBR)
기간: Up to approximately 36 months

DBR: proportion of subjects who experience CR, PR, or stable disease with tumor reduction (SDTR)
Up to approximately 36 months
Progression free survival (PFS)
기간: Up to approximately 36 months

PFS: interval from the start of study drug administration to the earlier of the first documentation of disease progression or death from any cause
Up to approximately 36 months
Duration of disease benefit (DDB)
기간: Up to approximately 36 months

DDB: interval from the first documentation of objective tumor regression to the earlier of the first documentation of disease progression or death from any cause in subjects with disease benefit
Up to approximately 36 months
Percent change in tumor dimensions
기간: Up to approximately 36 months

percent change from baseline in the sum of the longest diameters of non-nodal target lesions and the shortest diameters of nodal target lesions
Up to approximately 36 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Solve Therapeutics

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)

2025년 5월 14일

기본 완료 (추정된)

2027년 8월 1일

연구 완료 (추정된)

2027년 11월 1일

연구 등록 날짜

최초 제출

2025년 1월 3일

QC 기준을 충족하는 최초 제출

2025년 1월 9일

처음 게시됨 (실제)

2025년 1월 13일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 18일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • SLV-154-01Tx

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

Results will be presented in clinical study reports and publications. Individual participant data will not be shared with other researchers.

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. .

구독하다