- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07726212
A First-in-human (FIH), Open-Label, Dose Escalation and Expansion Cohorts Study of MC002
A First-in-human (FIH), Open-Label, Dose Escalation and Expansion Cohorts Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) Characteristics, and Preliminary Efficacy of MC002 in Participants With Locally Advanced/Metastatic Solid Tumors
The goal of this clinical trial is to learn if ADC drug MC002 works to treat locally advanced/metastatic solid tumors in adults. It will also learn about the safety of MC002. The main questions it aims to answer are:
Does participants tolerate the drug MC002 ? What medical problems do participants have when treating with MC002? Does participants benefit from the MC002
.
Participants will:
Intravenous infusion MC002 every 3 weeks in clinical Visit the clinic once every 3 weeks for checkups and tests Keep a diary of their symptoms
연구 개요
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Medical Director
- 전화번호: +86 13306139991
- 이메일: ke.chen@mlkbiotech.com
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 18 years of age and over, male or female, able to understand and willing to sign the Informed Consent Form (ICF).
- Life expectancy of 3 month or greater
- participants with histologically or cytologically confirmed recurrent or metastatic unresectable advanced solid tumors who experience disease progression after receiving systemic standard therapy, or have no standard therapy.
- At least one measurable lesion as assessed by RECIST 1.1
- Adequate organ functions.
- ECOG Performance Status (PS) of 0-1
Exclusion Criteria:
- Pregnant or nursing females.Participants who have received chemotherapy, investigational therapy, immunotherapy, or any other antitumor active drugs within 4 weeks or 5 half-lives (whichever is shorter) before the first dose.
- Known hypersensitivity to either the drug substances or inactive ingredient
- Participants who have undergone a bone marrow transplantation, solid organ transplantation, stem cell transplant.
- Participants with QTc >470 msec.
- Use of ≥10 mg of prednisone or equivalent dose of steroids per day within 3 months of administration (inhaled, intranasal, intraocular, topical and intraarticular joint injections of corticosteroids are allowed).Participants with a history of HCV infection who have not completed curative anti HCV treatment and whose HCV load is above the limit of quantification. Concurrent HCV treatment is not allowed in the trial.Live viral vaccine therapies within 4 weeks prior to the first dose of study drug.
- Participants who have received treatment with any herbal or alternative therapies within 7 days prior to the first dose of the study drug.
- Male and female participants of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 순차적 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: dose escalation
MC002 dose escalation
|
MC002 is a recombinant antibody-drug conjugate targeting the oncofetal antigen.A complete treatment cycle is defined as 21 calendar days.
MC002 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
To assess the Number of patients with Adverse Events (AE)
기간: From enrollmenFrom enrollment until 28 days after last study drug t to the safety follow up
|
Any medical event in a participant which may or may not have a causal relationship with this treatment.
|
From enrollmenFrom enrollment until 28 days after last study drug t to the safety follow up
|
|
Determination of MTD or RP2D
기간: From enrollment until 28 days after last study drug
|
Maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of MC002
|
From enrollment until 28 days after last study drug
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Maximum concentration (Cmax)
기간: From enrollment until 28 days after last study drug
|
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Cmax will be derived).
|
From enrollment until 28 days after last study drug
|
|
ADA
기간: From enrollment until 28 after last study drug
|
Incidence, onset time, and titer of ADAs against MC002
|
From enrollment until 28 after last study drug
|
|
The time taken to reach the maximum concentration (Tmax)
기간: From enrollment until 28 days after last study drug
|
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Tmax will be derived).
|
From enrollment until 28 days after last study drug
|
|
Area Under Curve (AUC)
기간: From enrollment until 28 days after last study drug
|
PK endpoint
|
From enrollment until 28 days after last study drug
|
|
Half life (T1/2)
기간: From enrollment until 28 days after last study drug
|
Half life (T1/2)
|
From enrollment until 28 days after last study drug
|
|
Trough concentration (Cmin)
기간: From enrollment until 28 days after last study drug
|
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Cmin will be derived)
|
From enrollment until 28 days after last study drug
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Overall response rate (ORR)
기간: From enrollment until 28 days after last study drug.
|
the proportion/percentage of participants with best overall response of CR or PR。
|
From enrollment until 28 days after last study drug.
|
|
progression-free survival (PFS)
기간: From enrollment until 28 days after last study drug.
|
assessed per RECISTv1.1
|
From enrollment until 28 days after last study drug.
|
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MC002 FIH Study
- Sponsor (기타 보조금/기금 번호: Sponsor)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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