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

Clinical Trial of HG146 Administered to Subjects With Advanced Solid Tumors or Lymphoma

2026년 9월 16일 업데이트: HitGen Inc.

A Phase I Open Label Study of HG146 Alone /in Combination With PD-(L)1 Inhibitor Administered With and Without Anticancer Agents in Participants With Advanced Solid Tumors or Lymphoma

This is a Phase I, open-label, repeat-dose, non-randomized, multicenter study to evaluate the safety, tolerability, and preliminary clinical activity and establish a recommended dose of HG146 administered orally (PO) alone (Part 1) or co-administered (Part 2) with PD-（L）1 inhibitor in subjects with refractory/relapsed solid tumors or Lymphoma. Part 1 consists of a dose escalation phae,Part2 consists of a dose escalation phase and a cohort expansion phase. In Part 1, escalating doses of HG146 will be evaluated as guided by the "3+3" approach. In Part 2A, escalating doses of HG146 in combination with PD-(L)1 inhibitor will be evaluated as guided by the "3+3" approach. In Part 2B, subjects will receive a single dose level of HG146 as identified based on data from Part 2, in combination with PD-(L)1 inhibitor . A total of approximately 96 subjects will be enrolled in this study, approximately 36 for dose escalation cohorts, and approximately 60 in the expansion cohorts.

연구 개요

상태

완전한

정황

개입 / 치료

연구 유형

중재적

등록 (실제)

24

단계

  • 1단계

연락처 및 위치

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

연구 장소

  • 중국
      • Beijing, 중국
        • National Cancer Center/Cancer Hospital

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

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

Key Inclusion Criteria:

1 Subject must be >=18 years of age at the time of signing the informed consent.

2- Ia/Ib dose escalation phase（Part1 and Part 2A）：Subjects with advanced/Metastatic solid tumors or Lymphoma, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established.

  • Ib dose expansion phase（Part 2）:

    1. Cohort 1,Subjects with advanced/Metastatic solid tumors or Lymphoma, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established, have not been treated with PD-(L)1 antibody； 2）Cohort 2,Subjects with advanced/Metastatic solid tumors or Lymphoma, who have progressed on, be intolerant of, or ineligible for, all available therapies for which clinical benefit has been established, have progressed on PD-(L)1 antibody； 3 Measurable disease per RECIST version 1.1 or Lugano 2014（If applicable）. 4 Has Eastern Cooperative Oncology Group (ECOG) Performance Status ≤1. 5 Has adequate organ function. 6 Signed informed consent form (ICF) and able to comply with study requirements.

Key Exclusion Criteria:

  1. Received prior therapies targeting HDAC.
  2. Symptomatic central nervous system (CNS) metastases that have required steroids within 4 weeks prior to first dose of study treatment.
  3. History of intolerant of anti-PD-(L)1 toxicity（Ib）.
  4. A condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of enrollment.
  5. Major surgery or major injury <=28 days before the first dose of study treatment,or anticipated major surgery during the study.
  6. Received other anticaner therapies within 4 weeks prior to first dose of study treatment or 5 half life period of anticancer drug .
  7. Active infection requiring systemic treatment.
  8. Prior allogeneic bone marrow transplantation or other solid organ transplantation ( Ib)
  9. Active autoimmune disease or disease of impaired immune system(Ib).
  10. History of Adrenal insufficiency.(Ib)
  11. History orConcurrent condition of other malignant tumors.
  12. Recent (within the past 6 months) history of Unstable or serious diseases, such as pancreatitis, severe angina, prolonged QT interval, congestive heart failure, myocardial infarction, pulmonary hypertension, stroke, and severe seizures, etc.
  13. History of severe lung disease.
  14. Any illness or medical conditions that are unstable or could jeopardize the safety of the patient and his/her compliance 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: Part 1:HG146 Monotherapy, Dose-escalation Cohort

Subjects will receive HG146 PO at every two days intervals (qod) for 14 consecutive days,7 days off, 21 days/ cycle. Escalating doses of HG146 will be evaluated using 3+3 approach.
의약품: HG146

HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.

다른 이름들:
  • HG146 capsule
실험적: Part 2A:HG146 + PD-(L)1 antibody, Dose escalation Cohort

Subjects will receive HG146 PO at every two days intervals (qod) for 14 consecutive days,7 days off, along with PD-(L)1 antibody IV once every 3 weeks (Q3W),21 days/ cycle.

Escalating doses of HG146 in combination with PD-(L)1 antibody will be evaluated.
의약품: HG146

HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.

다른 이름들:
  • HG146 capsule
의약품: PD-(L)1 antibody

PD-(L)1 Antibody is available as solution for infusion or lyophilized powder for reconstitution to be administered Q3W. It will be administered as an IV infusion for 30 minutes.

다른 이름들:
  • PD-1 항체
실험적: Part 2B-1：HG146 combination Expansion Cohort 1

Subjects who have not been treated with PD-(L)1 antibody，will receive HG146 po for 14 consecutive days,7 days off, in combination with PD-(L)1 antibody IV Q3W.
의약품: HG146

HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.

다른 이름들:
  • HG146 capsule
의약품: PD-(L)1 antibody

PD-(L)1 Antibody is available as solution for infusion or lyophilized powder for reconstitution to be administered Q3W. It will be administered as an IV infusion for 30 minutes.

다른 이름들:
  • PD-1 항체
실험적: Part 2B-2：HG146 combination Expansion Cohort 2

Subjects who have progressed on PD-(L)1 antibody, will receive HG146 po for 14 consecutive days,7 days off, in combination with PD-(L)1 antibody IV Q3W.
의약품: HG146

HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.

다른 이름들:
  • HG146 capsule
의약품: PD-(L)1 antibody

PD-(L)1 Antibody is available as solution for infusion or lyophilized powder for reconstitution to be administered Q3W. It will be administered as an IV infusion for 30 minutes.

다른 이름들:
  • PD-1 항체

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Part I：Dose-Limiting Toxicities (DLTs)
기간: Up to 26 Days in Cycle 0 and Cycle 1

Number of participants experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE V5.0)
Up to 26 Days in Cycle 0 and Cycle 1
Part I：Serious Adverse Events (SAEs) and Adverse Events (AE)
기간: Up to 2 years

Number of participants experiencing Serious Adverse Events (SAEs) and Adverse Events (AE) According to Safety performance.
Up to 2 years
Part I：Maximum tolerated dose or Recommended Phase Ib dose (RP2D) of HG146
기간: Up to 2 years

Maximum tolerated dose or Recommended Phase II dose of HG146 will be decided according to safety and effective results.
Up to 2 years
Part 2A: Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE v.5.0)
기간: Up to 21 Days in Cycle 1

Number of participants experiencing Dose-Limiting Toxicities (DLTs) According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE V5.0)
Up to 21 Days in Cycle 1
Part 2A: Serious Adverse Events (SAEs) and Adverse Events (AE)
기간: Up to 2 years

Number of participants experiencing Serious Adverse Events (SAEs) and Adverse Events (AE) According to Safety performance.
Up to 2 years
Part 2A:Maximum tolerated dose or Recommended Phase II dose (RP2D) of HG146 in combination with PD-(L)1 antibody
기간: Up to 2 years

Maximum tolerated dose or Recommended Phase II dose of HG146 will be decided according to safety and effective results.
Up to 2 years

2차 결과 측정

결과 측정
측정값 설명
기간
Part 1:Area under the concentration versus time curve (AUC) of HG146
기간: At the end of Cycle 0 Day 5 (Cycle 0 is 5 days);At the end of Cycle 1 Day15 (Except for cycle 0, each cycle is 21 days)

Plasma concentration of HG146 will be measured following single dose and multiple dose administration
At the end of Cycle 0 Day 5 (Cycle 0 is 5 days);At the end of Cycle 1 Day15 (Except for cycle 0, each cycle is 21 days)
Part 1:Peak plasma concentration (Cmax) of HG146
기간: At the end of Cycle 0 Day 5 (Cycle 0 is 5 days);At the end of Cycle 1 Day15 (Except for cycle 0, each cycle is 21 days)

Plasma concentration of HG146 will be measured following single dose and multiple dose administration
At the end of Cycle 0 Day 5 (Cycle 0 is 5 days);At the end of Cycle 1 Day15 (Except for cycle 0, each cycle is 21 days)
Part 1:Time of Cmax (Tmax) of HG146
기간: At the end of Cycle 0 Day 5 (Cycle 0 is 5 days);At the end of Cycle 1 Day15(Except for cycle 0, each cycle is 21 days)

Plasma concentration of HG146 will be measured following single dose and multiple dose administration
At the end of Cycle 0 Day 5 (Cycle 0 is 5 days);At the end of Cycle 1 Day15(Except for cycle 0, each cycle is 21 days)
Part 1:Apparent terminal half-life (T1/2) of HG146
기간: At the end of Cycle 0 Day 5 (Cycle 0 is 5 days);At the end of Cycle 1 Day15 (Except for cycle 0, each cycle is 21 days)

Plasma concentration of HG146 will be measured following single dose and multiple dose administration
At the end of Cycle 0 Day 5 (Cycle 0 is 5 days);At the end of Cycle 1 Day15 (Except for cycle 0, each cycle is 21 days)
Part1: objective response rate (ORR)
기간: Up to 2 years

ORR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Up to 2 years
Part1: Best overall response (BOR)
기간: Up to 2 years

BOR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Up to 2 years
Part1: Duration of response (DOR)
기간: Up to 2 years

DOR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Up to 2 years
Part 1:Time-to-response (TTR)
기간: Up to 2 years

TTR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Up to 2 years
Part 1:Progression-Free Survival (PFS)
기간: Up to 2 years

PFS will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Up to 2 years
Part 2:Area under the concentration versus time curve (AUC) of HG146
기간: At the end of Cycle 1 Day 15 (each cycle is 21 days)

Plasma concentration of HG146 will be measured following multiple dose administration in combination with PD-(L)1 antibody
At the end of Cycle 1 Day 15 (each cycle is 21 days)
Part 2:maximum observed plasma concentration (Cmax) of HG146
기간: At the end of Cycle 1 Day 15 (each cycle is 21 days)

Plasma concentration of HG146 will be measured following multiple dose administration in combination with PD-(L)1 antibody
At the end of Cycle 1 Day 15 (each cycle is 21 days)
Part 2:time of maximum observed plasma concentration (Tmax) of HG146
기간: At the end of Cycle 1 Day 15 (each cycle is 21 days)

Plasma concentration of HG146 will be measured following multiple dose administration in combination with PD-(L)1 antibody
At the end of Cycle 1 Day 15 (each cycle is 21 days)
Part 2:apparent terminal half-life (T1/2) of HG146
기간: At the end of Cycle 1 Day 15 (each cycle is 21 days)

Plasma concentration of HG146 will be measured following multiple dose administration in combination with PD-(L)1 antibody
At the end of Cycle 1 Day 15 (each cycle is 21 days)
Part2: objective response rate (ORR)
기간: Up to 2 years

ORR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Up to 2 years
Part2: Best overall response (BOR)
기간: Up to 2 years

BOR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Up to 2 years
Part2: Duration of response (DOR)
기간: Up to 2 years

DOR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Up to 2 years
Part 2:Time-to-response (TTR)
기간: Up to 2 years

TTR will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Up to 2 years
Part 2:Progression-Free Survival (PFS)
기간: Up to 2 years

PFS will be assessed by the Investigators using RECIST v. 1.1 or Lugano 2014( If applicable)
Up to 2 years
Overall survival (OS)
기간: Up to 2 years

OS will be assessed by the investigators
Up to 2 years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

HitGen Inc.

수사관

  • 수석 연구원: Yuankai Shi, National Cancer Center/Cancer Hospital

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)

2021년 9월 23일

기본 완료 (실제)

2024년 6월 13일

연구 완료 (실제)

2024년 12월 22일

연구 등록 날짜

최초 제출

2021년 7월 12일

QC 기준을 충족하는 최초 제출

2021년 7월 23일

처음 게시됨 (실제)

2021년 7월 26일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 9월 21일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 16일

마지막으로 확인됨

2026년 9월 1일

추가 정보

이 연구와 관련된 용어

추가 관련 MeSH 약관

기타 연구 ID 번호

  • HG146CN102

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

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