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A Study of Rocbrutinib in Combination With Lacutoclax in Patients With B-Cell Malignancies

2026년 7월 29일 업데이트: Guangzhou Lupeng Pharmaceutical Company LTD.

A Phase Ib/II, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of BTK Inhibitor Rocbrutinib in Combination With BCL-2 Inhibitor Lacutoclax in Patients With B-Cell Malignancies

BTK inhibitors and BCL-2 inhibitors have demonstrated significant clinical activity in mature B-cell malignancies, and combination therapy may provide improved clinical benefit. This is a multi-center, open-label, single-arm Phase Ib/II clinical study. The purpose of this clinical trial is to investigate the safety, tolerability, pharmacokinetics, and preliminary efficacy of Rocbrutinib, a fourth-generation Bruton tyrosine kinase inhibitor (BTKi), in combination with the BCL-2 inhibitor Lacutoclax in patients with mature B-cell malignancies. The Phase Ib will use a classic 3+3 dose-escalation design to evaluate dose-limiting toxicities (DLTs), determine the maximum tolerated dose (MTD), and identify the recommended dosing regimen. The Phase II portion is intended to further evaluate the efficacy and safety of the combination therapy.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

92

단계

  • 2 단계
  • 1단계

연락처 및 위치

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

연구 연락처

연구 장소

  • 중국
      • Tianjin, 중국
        • 모병
        • Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
        • 연락하다:

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

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  1. Age ≥18 years, regardless of sex.

  2. Ib: Histologically confirmed diagnosis of CLL/SLL (per 2018 iwCLL criteria) or B-cell malignancies (per 2022 WHO classification), including: MCL, DLBCL, FL, and WM. Must have received at least one prior line of systemic therapy, with documented disease progression or intolerance.

    II: For Treatment-naïve (TN) CLL/SLL patients: Must meet iwCLL treatment indications and no prior systemic therapy. For R/R CLL/SLL patients: at least one prior systemic therapy with documented disease progression or intolerance.

  3. Have at least one measurable lesion.
  4. Phase Ib: ECOG performance status ≤1; phase II: ECOG performance status ≤2.
  5. Life expectancy ≥ 12 weeks.
  6. Adequate coagulation function, liver and kidney function, bone marrow hematopoietic function.
  7. Male patients and female patients of childbearing potential must agree to use effective contraception during the study and for 90 days after the last dose of study treatment. Female patients of childbearing potential must have a negative pregnancy test before study treatment and must not be breastfeeding. Male patients must not donate sperm during the study and for 90 days after the last dose.
  8. Participation is voluntary, requiring signed informed consent and compliance with the treatment regimen and visit schedule.

Exclusion Criteria:

  1. Known hypersensitivity or intolerance to Rocbrutinib, Lacutoclax, or any of their excipients; prior treatment with any BCL-2 inhibitor; or prior treatment with both covalent and non-covalent BTK inhibitors.
  2. Use of systemic corticosteroids at doses equivalent to >20 mg/day of prednisone for ≥3 days within 7 days prior to the first dose.
  3. History of or currently suspected Richter's syndrome.
  4. Known or suspected central nervous system (CNS) involvement.
  5. Prior allogeneic hematopoietic stem cell transplantation (allo-HSCT), or autologous hematopoietic stem cell transplantation (auto-HSCT) or chimeric antigen receptor T-cell (CAR-T) therapy within 90 days before the first dose of study treatment.
  6. Received antitumor therapy, investigational agents, major surgery, severe trauma, or live attenuated vaccines within 4 weeks or 5 half-lives prior to the first dose of study treatment.
  7. Received herbal medicines for antitumor treatment, or localized radiotherapy within 14 days prior to the first dose of study treatment.
  8. Use of moderate or strong CYP3A inhibitors within 7 days prior to the first dose of study treatment, or consumption of grapefruit, grapefruit juice, starfruit, or Seville oranges within 3 days prior to prior to the first dose.
  9. History of other active malignancies within the past 3 years, except for curatively treated basal cell carcinoma, localized squamous cell carcinoma of the skin, carcinoma in situ of the cervix or breast, or other malignancies considered cured.
  10. Any severe and/or uncontrolled systemic disease, or any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in the study.
  11. Any of the following events within 6 months prior to the first dose: Symptomatic arrhythmia, myocardial infarction, intracranial hemorrhage, or Stroke.
  12. Impaired cardiac function.
  13. Any uncontrolled systemic infection.
  14. Conditions that may impair oral drug administration or significantly affect absorption or pharmacokinetics of the study drug.
  15. Unable to discontinue moderate or strong CYP3A inhibitors or inducers, P-gp (P-glycoprotein) inhibitors, sensitive substrates of OATP1B3 or CYP2C8 during the study period.
  16. Received vaccination with any live-attenuated vaccines within 4 weeks prior to the first dose of study treatment.
  17. Evidence of an active bleeding constitution or a history of significant hemorrhagic disorders.
  18. Requirement for ongoing therapy with warfarin or other vitamin K antagonists.
  19. Presence of an active, uncontrolled, or symptomatic autoimmune disease that requires systemic treatment.
  20. Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.

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: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Lacutoclax+Rocbrutinib
의약품: Lacutoclax+Rocbrutinib

Phase Ib dose-escalation study of Rocbrutinib in combination with Lacutoclax. Rocbrutinib will be administered at a fixed dose of 150 mg once daily (QD), while Lacutoclax will be dose-escalated. Initial dose levels include Lacutoclax 200 mg QD and 400 mg QD in 28-day treatment cycles.Treatment will continue until disease progression, unacceptable toxicity/intolerance, or completion of the protocol-defined treatment duration, whichever occurs first.

In phase II, participants will receive Rocbrutinib monotherapy for 8-12 weeks prior to combination treatment. Upon initiation of combination therapy, Lacutoclax will undergo dose ramp-up to the target dose and will then be administered continuously at the target dose. Treatment will continue until disease progression, unacceptable toxicity/intolerance, or completion of the protocol-defined treatment duration, whichever occurs first.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
기간
Phase Ib: Dose-limiting toxicity (DLT)
기간: At the end of Cycle 1 (the length of cycle 1 is 28 days)
At the end of Cycle 1 (the length of cycle 1 is 28 days)
Phase Ib: Maximum Tolerated Dose (MTD)
기간: At the end of Cycle 1 (the length of cycle 1 is 28 days)
At the end of Cycle 1 (the length of cycle 1 is 28 days)
Phase Ib: Adverse events as assessed by CTCAE v5.0
기간: From the first administration to 28 days after the last administration
From the first administration to 28 days after the last administration
Phase Ib: Time to Maximum Plasma Concentration (Tmax)
기간: From 1 hour prior to administration to 24 hours post-dose
From 1 hour prior to administration to 24 hours post-dose
Phase Ib: Maximum Plasma Concentration (Cmax)
기간: From 1 hour prior to administration to 24 hours post-dose
From 1 hour prior to administration to 24 hours post-dose
Phase Ib: Area Under the Plasma Concentration-Time Curve from Time Zero to Time t (AUC0-t)
기간: From 1 hour prior to administration to 24 hours post-dose
From 1 hour prior to administration to 24 hours post-dose
Phase Ib: Half-life (t1/2)
기간: From 1 hour prior to administration to 24 hours post-dose
From 1 hour prior to administration to 24 hours post-dose
Phase II: Undetectable minimal residual disease (uMRD) rate assessed by flow cytometry
기간: Up to approximately three years
Up to approximately three years

2차 결과 측정

결과 측정
기간
Phase II: Maximum Plasma Concentration (Cmax)
기간: From 1 hour prior to administration to 24 hours post-dose
From 1 hour prior to administration to 24 hours post-dose
Phase II: Time to Maximum Plasma Concentration (Tmax)
기간: From 1 hour prior to administration to 24 hours post-dose
From 1 hour prior to administration to 24 hours post-dose
Phase II: Area Under the Plasma Concentration-Time Curve from Time Zero to Time t (AUC0-t)
기간: From 1 hour prior to administration to 24 hours post-dose
From 1 hour prior to administration to 24 hours post-dose
Phase II: Half-life (t1/2)
기간: From 1 hour prior to administration to 24 hours post-dose
From 1 hour prior to administration to 24 hours post-dose
Overall Response Rate(ORR)
기간: Up to approximately three years
Up to approximately three years
Progression-free Survival(PFS)
기간: Up to approximately three years
Up to approximately three years
Overall Survival(OS)
기간: Up to approximately three years
Up to approximately three years
Phase II: Adverse events as assessed by CTCAE v5.0
기간: From the first administration to 28 days after the last administration
From the first administration to 28 days after the last administration
Complete Response Rate (CRR)
기간: Up to approximately three years
Up to approximately three years
Duration of Response (DOR)
기간: Up to approximately three years
Up to approximately three years
Phase Ib: Undetectable Minimal Residual Disease (uMRD) Rate assessed by flow cytometry
기간: Up to approximately three years
Up to approximately three years

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Guangzhou Lupeng Pharmaceutical Company LTD.

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)

2026년 7월 14일

기본 완료 (추정된)

2029년 6월 30일

연구 완료 (추정된)

2033년 5월 30일

연구 등록 날짜

최초 제출

2026년 5월 20일

QC 기준을 충족하는 최초 제출

2026년 5월 20일

처음 게시됨 (실제)

2026년 5월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 30일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 29일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • LP-10822

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. .

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