This is a Phase 1/1b Study to Evaluate the Safety and Preliminary Antitumor Activity of LTZ-232 in Participants With Advanced/Metastatic Colorectal Cancer and Other Solid Tumors
A Phase 1/1b, Muticenter Study to Evaluate the Safety and Preliminary Antitumor Activity of LTZ-232 in Participants With Advanced/Metastatic Colorectal Cancer and Other Solid Tumors
This is a first-in-human, Phase 1, multi-center, open-label study to characterize the safety, pharmacokinetics, pharmacodynamics, and preliminary anti tumor activity of LTZ-232 as monotherapy in adult participants with unresectable or metastatic colorectal cancer and other solid tumors failing standard therapies.
연구 개요
상세 설명
LTZ-232 is an engineered anti-EPCAM bispecific antibody designed to activate tumor-associated macrophages to phagocytose and kill tumor cells.
연구 유형
등록 (추정된)
단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Sherry Unabia
- 전화번호: 669-207-0084
- 이메일: sherry.unabia@ltztherapeutics.com
연구 장소
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Arizona
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Scottsdale, Arizona, 미국, 85258
- 모병
- HonorHealth Research Institute
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수석 연구원:
- Sunil Sharma, MD
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연락하다:
- Stephanie Stanford
- 전화번호: 480-323-1350
- 이메일: stsanford@honorhealth.com
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Advanced /metastatic colorectal tumors that have failed standard treatments
- Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)
- Eastern Cooperative Oncology Group performance status (ECOG PS) ≤ 1
- Adequate organ function based on laboratory testing
Exclusion Criteria:
- Active infection with hepatitis B or C
- Uncontrolled CNS metastases
- Active autoimmune disease
- Clinically significant cardiovascular disease not adequately controlled with medication or impaired function
- Previous treatment with EpCAM targeting agent
- Pregnant or breast feeding
- Non-colorectal active malignancy within 3 years that could interfere with study interpretation
공부 계획
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 |
|---|---|
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실험적: Dose Escalation in metastatic colorectal cancer
Participants in this arm will participate in one (1) of up to eight (8) escalating defined dose level cohorts. Participants may receive LTZ-232 intravenously up to 24 months unless treatment discontinuation criteria are met. |
LTZ-232 will be administered intravenously every two weeks for up to 24 months unless treatment discontinuation criteria are met. |
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실험적: Safety/PK/Pharmacodynamic Cohorts
Participants may be dosed with LTZ-232 intravenously at levels previously declared safe to further explore safety and clinical activity at particular dose levels. |
LTZ-232 will be administered intravenously every two weeks for up to 24 months unless treatment discontinuation criteria are met. |
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실험적: Dose Expansion in metastatic colorectal cancer and other solid tumor types
Participants with unresectable or metastatic colorectal cancer and other specific solid tumor types at a LTZ-232 dosing regimen(s) identified from dose escalation. |
LTZ-232 will be administered intravenously every two weeks for up to 24 months unless treatment discontinuation criteria are met. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Characterize the Safety and Tolerability of LTZ-232 in metastatic colorectal cancer and other solid tumors using the incidence, severity, and type of adverse events according to CTCAE v5.0.
기간: Up to 24 months
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To determine the incidence, severity, and type of adverse events according to NCI and CTCAE v5.0 and assessment of protocol defined dose limiting toxicity criteria. |
Up to 24 months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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. .