Phase 1 Study of MST-168 in Participants With Advanced Solid Malignant Tumors
A Phase 1, Multiregional, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of MST-168, in Participants With Advanced Solid Malignant Tumors
A Phase 1, multiregional, open-label study of MST-168 in participants with target-driven advanced solid tumors.
The goal of this clinical trial is to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, pharmacodynamic effects, and preliminary efficacy of MST-168 in participants with target-driven advanced solid tumors. MST-168 is an investigational ADC.
연구 개요
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Changlong Liu
- 전화번호: +86-15810213012
- 이메일: changlong.liu@mabsoftbio.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Participants are eligible to be included in the study only if all of the following criteria apply:
I1. Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in this protocol.
I2. Is at least 18 years of age at the time of signing the ICF.
I3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
I4. Life expectancy ≥ 12 weeks.
I5. Has adequate organ function.
I6. Pregnancy and Contraception: Female participants agree not to be pregnant or lactating from beginning of the study screening until 6 months after receiving the last treatment. Male participants with partners of childbearing potential and female participants of childbearing potential are willing and able to employ a highly effective method of birth control/contraception to prevent pregnancy from beginning of the study screening until 6 months after receiving the last treatment of MST-168.
I7. Has a pathologically documented advanced/unresectable or metastatic solid tumor that is refractory to or intolerable with standard treatment, or for which no standard treatment is available.
Exclusion Criteria:
- Participants are excluded from the study if any of the following criteria apply:
E1. Has untreated brain or CNS metastases or brain/CNS metastases that have progressed [e.g., evidence of new or enlarging brain metastasis or new neurologic symptoms attributable to brain/CNS metastases]. Participants with previously unstable brain or CNS metastases.
E2. Has a malignancy (except disease under study) that has progressed or required active treatment within the past 24 months except for basal cell or squamous cell carcinomas of the skin or in-situ carcinomas [e.g., breast, cervix, bladder] that have been resected with no evidence of metastatic disease.
E3. Has any history of prior allogenic or autologous bone marrow transplant or other solid organ transplant.
E4. Has known sensitivity to study intervention components or excipients.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: MST-168 initial dose level treatment Cohort
MST-168 initial dose level
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
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실험적: MST-168 dose level 2 treatment Cohort
MST-168 dose level 2
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
|
실험적: MST-168 dose level 3 treatment Cohort
MST-168 dose level 3
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
|
실험적: MST-168 dose level 4 treatment Cohort
MST-168 dose level 4
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
|
실험적: MST-168 dose level 5 treatment Cohort
MST-168 dose level 5
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
|
실험적: MST-168 dose level 6 treatment Cohort
MST-168 dose level 6, if needed
|
MST-168 is a proprietary antibody-drug conjugate (ADC) developed by Mabsoft Therapeutics.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Incidence of dose-limiting toxicities (DLT)
기간: Day 1 - Day 28
|
Day 1 - Day 28
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Incidence and severity of AEs, clinically significant changes from Baseline (pre-dose on D1) through to the EOT in vital signs, laboratory tests, physical examinations, 12-lead ECG, and ECHO/MUGA.
기간: Through study completion, up to 25 months
|
Through study completion, up to 25 months
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
PK parameters for MST-168, total anti-drug antibody and free payload: Tmax
기간: Day 1 to Day 8
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Day 1 to Day 8
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PK parameters for MST-168, total anti-drug antibody and free payload: Cmax
기간: Day 1 to Day 8
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Day 1 to Day 8
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PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-t
기간: Day 1 to Day 8
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Day 1 to Day 8
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PK parameters for MST-168, total anti-drug antibody and free payload: AUC0-∞
기간: Day 1 to Day 8
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Day 1 to Day 8
|
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PK parameters for MST-168, total anti-drug antibody and free payload: t1/2
기간: Day 1 to Day 8
|
Day 1 to Day 8
|
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PK parameters for MST-168, total anti-drug antibody and free payload: CL
기간: Day 1 to Day 8
|
Day 1 to Day 8
|
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PK parameters for MST-168, total anti-drug antibody and free payload: Vss
기간: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: AUCss
기간: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
PK parameters for MST-168, total anti-drug antibody and free payload: Css,max
기간: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
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PK parameters for MST-168, total anti-drug antibody and free payload: Css,min
기간: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
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Frequencies of ADAs and neutralizing antibodies specific to MST-168.
기간: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
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Biomarkers: cytokines/chemokines and immune cell phenotypes
기간: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
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Objective response rate (ORR) based on RECIST v1.1.
기간: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
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Duration of response (DoR) based on RECIST v1.1.
기간: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Progression-free survival (PFS) based on RECIST v1.1.
기간: Through study completion, up to 24 months
|
Through study completion, up to 24 months
|
|
Disease control rate (DCR) based on RECIST v1.1.
기간: Through study completion, up to 24 months
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Through study completion, up to 24 months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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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