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Recruiting NCT07556822

Phase I Study of HRS-3005 in B-cell Malignancies

Phase I Interventional B-cell Malignancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HRS-3005.
Who it may be relevant to
Registry conditions: B-cell Malignancy. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

An Open-Label, Multicenter, Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HRS-3005 in Patients With B-cell Malignancies

Overview

The study is being conducted to evaluate the safety and tolerability of HRS-3005. To explore the Maximum Tolerated Dose (MTD, if possible) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of HRS-3005 in patients with B-cell malignancy.

Interventions

  • Drug HRS-3005
    HRS-3005

Primary outcome measures

  • Safety Endpoints: Incidence of adverse events (AEs)，number of participants with abnormal laboratory test results . [Time frame: approximately 1 year]
  • MTD（Maximum tolerated dose） [Time frame: 28 days after treatment initiation]
  • RP2D（Recommended Phase II Dose） [Time frame: approximately 2 year.]
Secondary outcome measures (11)
  • Peak Concentration (Cmax) [Time frame: 12 weeks after treatment initiation]
  • Time to Peak Concentration (Tmax) [Time frame: 12 weeks after treatment initiation;]
  • Area Under the Curve (AUC0-t, AUC0-inf) [Time frame: 12 weeks after treatment initiation;]
  • Half-life (t1/2) [Time frame: 12 weeks after treatment initiation;]
  • Apparent Clearance (CL/F) [Time frame: 12 weeks after treatment initiation;]
  • Apparent Volume of Distribution (Vz/F) [Time frame: 12 weeks after treatment initiation]
  • Objective Response Rate (ORR) [Time frame: approximately 1 year;]
  • Time to Response (TTR) [Time frame: approximately 1 year;]
  • Duration of Response (DoR) [Time frame: approximately 1 year;]
  • Progression-Free Survival (PFS) [Time frame: approximately 1 year;]
  • Overall Survival (OS) [Time frame: approximately 1 year]

Eligibility criteria

Inclusion criteria

  • Age ≥18 years;
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
  • Life expectancy ≥12 weeks;
  • Histologically or cytologically confirmed relapsed/refractory B-cell malignancies;
  • Measurable disease;
  • Adequate organ function;
  • Females of childbearing potential must not be pregnant or lactating. Females of childbearing potential and males with partners of childbearing potential must agree to use effective contraception from the time of informed consent until 28 days after the last dose of study treatment;
  • Voluntary participation with signed informed consent, good compliance, and willingness to complete follow-up visits.

Exclusion criteria

  • Known central nervous system (CNS) involvement by malignancy;
  • History of other malignancy within 2 years prior to first dose of study drug, except for the disease under study;
  • Prior autologous stem cell transplantation or CAR-T therapy within 12 weeks before first dose of study drug;
  • Prior allogeneic hematopoietic stem cell transplantation;
  • Positive hepatitis B surface antigen (HBsAg) with detectable HBV-DNA at screening;
  • Positive hepatitis C antibody with detectable HCV-RNA at screening;
  • Positive HIV antigen/antibody test at screening;
  • Active fungal, bacterial, and/or viral infection requiring systemic therapy;
  • Major surgery or significant trauma within 28 days prior to first dose of study drug;
  • Severe disease of major organ systems;
  • Prior anti-tumor treatment-related adverse events not recovered to ≤Grade 1 or stable status;
  • Incomplete washout period from prior anti-tumor therapy before first dose of study drug;
  • Use of strong or moderate CYP3A inducers, or strong or moderate CYP3A inhibitors within 14 days prior to first dose of study drug;
  • Live vaccine administration within 28 days prior to first dose of study drug;
  • Ongoing alcohol or drug abuse;
  • Intracranial hemorrhage within 6 months prior to first dose of study drug;
  • Currently receiving vitamin K antagonists or Factor Xa inhibitors;
  • History of severe bleeding disorder, such as coagulation factor deficiency or von Willebrand factor (vWF) deficiency;
  • Inability to swallow oral medication, or presence of severe gastrointestinal disease or prior surgery significantly affecting gastrointestinal function;
  • Pregnant or lactating females;
  • Concurrent participation in another interventional clinical study, or less than 1 month between signing informed consent and last dose of previous clinical study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Hematology Hospital of the Chinese Academy of Medical Sciences — Tianjin

Identifiers

NCT: NCT07556822 · HRS-3005-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗