HRS-1635 in B-cell cancers: a first-in-human dose study

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial administers HRS-1635 to adults with relapsed or refractory B-cell malignancies to evaluate safety and tolerability, identify dose-limiting toxicities, and determine the maximum tolerated dose and RP2D. The study uses a dose-escalation approach to establish a safe dose for subsequent research while collecting preliminary signals of efficacy. Eligible participants are adults with good performance status who have confirmed B-cell tumors and meet specific health criteria. Key safety monitoring includes regular assessments and lab tests, with strict exclusion of patients with CNS involvement or recent other cancers. The trial is conducted at Sichuan Cancer Hospital in Chengdu under a lead sponsor with collaboration from Chengdu Suncadia Medicine Co., Ltd.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age ≥ 18 years old;
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
3. Expected survival time ≥ 12 weeks;
4. Histologically or cytologically confirmed relapsed/refractory B-cell malignant tumor;
5. Females of childbearing potential and male participants whose partners are females of childbearing potential must agree to adopt adequate and effective contraceptive measures during the study period. Female participants must not be breastfeeding;
6. Participants voluntarily enroll in the study, sign the informed consent form, with good compliance and willingness to cooperate with follow-up procedures.

Exclusion Criteria:

1. Tumor infiltration of the central nervous system;
2. A history of other malignant tumors (excluding the study disease) within 2 years prior to the first administration of the study drug;
3. A history of allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
4. Positive for hepatitis B surface antigen (HBsAg) at screening with evidence of viral replication confirmed by HBV-DNA test;
5. Positive for hepatitis C virus antibody (HCV-Ab) at screening with evidence of viral replication confirmed by HCV-RNA test;
6. Positive for human immunodeficiency virus (HIV) antigen/antibody test at screening;
7. History of major surgery or severe trauma within 28 days prior to the first administration of the study drug;
8. Presence of severe cardiovascular disease.;
9. Persistent alcohol or drug abuse;
10. Inability to take oral medication, or presence of severe gastrointestinal dysfunctional diseases, or history of surgery with severe impact on gastrointestinal function.
11. Pregnant or lactating females.
12. Concurrent participation in other interventional clinical trials, or an interval of less than 1 month between the signing date of the informed consent form and the last administration of the study drug in the previous clinical trial;

Where it's running

• Sichuan Cancer Hospital
  Chengdu, Sichuan, China Recruiting

Study contacts

• Study coordinator: Bin Hu
• Email: bin.hu5@hengrui.com
• Phone: +86-0518-82342973

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.