Study of CD137 Agonist ADG106 With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma
A Study of CD137 Agonist ADG106 Administered Intravenously in Patients With Advanced or Metastatic Solid Tumors and/or Non-Hodgkin Lymphoma
This is a Phase 1, open-label, dose-escalation, multicenter study of ADG106 in subjects with advanced or metastatic solid tumors and/or relapsed/refractory non-Hodgkin lymphoma. ADG106 is a fully human ligand-blocking, agonistic anti-CD137 IgG4 mAb. It binds to the activated human T cells via a T cell receptor CD137. T cell is a kind of lymphocyte (a subtype of white blood cells) that protects bodies by eliminating tumor cells, and normal cells infected with viruses or bacteria. By binding to CD137, the study drug is expected to enhance the activity of activated T cells and thus stimulate a more intense immune attack to kill tumor cells. ADG106 is expected to enhance the activity of activated T cells.
The primary objective of the study is to assess safety and tolerability at increasing dose levels of single agent ADG106 in subjects with advanced or metastatic solid tumors and/or non Hodgkin lymphoma Secondary Objectives
- To characterize the pharmacokinetic (PK) profiles of ADG106
- To evaluate the immunogenicity of ADG106
- To evaluate the potential anti-tumor effect of ADG106 Exploratory Objective To identify the potential biomarkers of ADG106
연구 개요
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Indiana
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Lafayette, Indiana, 미국, 47905
- Horizon Oncology Research
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Texas
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San Antonio, Texas, 미국, 78229
- NEXT Oncology
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria
- Male or female, 18 years of age or older at the time of consent.
- Provide written informed consent.
- Subjects with advanced and/or metastatic histologically or cytologically confirmed solid tumor and/or non-Hodgkin lymphoma who are refractory or relapsed from standard therapy and who have exhausted all available therapies.
- Life expectancy of 12 weeks or greater.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- At least one measurable lesion per RECIST 1.1 for solid tumors and per Lugano Classification for non-Hodgkin lymphoma.
- Adequate organ and bone marrow function
- Women of childbearing potential (WOCBP) must have a negative serum pregnancy test within the 7 days prior to study drug administration.
Exclusion Criteria
- Active central nervous system primary or secondary malignancies, active seizure disorder, spinal cord compression, or carcinomatous meningitis.
- Any active autoimmune disease or documented history of autoimmune disease.
- Infection of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV), except for the following:
- History of any non-infectious hepatitis (eg, alcohol or non-alcoholic steatohepatitis, drug-related or auto-immune hepatitis).
- History of clinically significant cardiac disease.
- Uncontrolled current illness.
8. WOCBP and sexually active fertile men with WOCBP partners who are unwilling or unable to use acceptable contraception method to avoid pregnancy.
9. Women who are pregnant at Screening or prior to study drug administration. 10. Women who are breastfeeding. 11. History of significant immune-mediated AE . 13. Systemic use of the following therapies within 28 days prior to the first dose of study drug, or longer.
14. Subjects who got either below treatment:
- Any previous anti-CD137 mAb (eg, utomilumab, urelumab) treatment.
- Subject who has received allogenic hematopoietic stem cell transplant or autologous stem cell transplanted.
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 |
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실험적: ADG106 용량 증량
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IV infusion over 60 minutes on Day 1 of each cycle, at doses of 0.03 mg/kg, 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg,10 mg/kg or 300mg flat dose depending on cohort at enrollment.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Number of participants experiencing dose-limiting toxicities
기간: 2 Cycles (42 days)
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2 Cycles (42 days)
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Number of participants experiencing clinical and laboratory adverse events (AEs)
기간: First dose to 28 days post last dose
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First dose to 28 days post last dose
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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The area under the curve (AUC) of plasma concentration of drug
기간: From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
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From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
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Maximum concentration (Cmax)
기간: From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
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From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
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Time at which maximum concentration (Tmax)
기간: From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
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From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
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Lowest plasma concentration (C[trough])
기간: From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
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From first dose (Cycle 1 Day 1, each cycle is 21 days) until the last dose (up to 2 years)
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공동 작업자 및 조사자
스폰서
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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. .
ADG106에 대한 임상 시험
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National University Hospital, SingaporeMerck Sharp & Dohme LLC; Adagene Inc모병
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Adagene Inc완전한
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National University Hospital, SingaporeBristol-Myers Squibb; Adagene Inc; Singapore Translational Cancer Consortium모병
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Adagene (Suzhou) Limited종료됨
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National University Hospital, SingaporeAdagene Inc모집하지 않고 적극적으로