Phase I Study of HRS-1635 in B-cell Malignancies

NCT07583212 | Not Yet Recruiting Phase 1

• 1 other identifier: HRS-1635-101
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the safety and tolerability of HRS-1635. To observe the Dose-Limiting Toxicity (DLT) , explore the Maximum Tolerated Dose (MTD, if possible) and the Recommended Phase 2 Dose (RP2D). This study also preliminarily evaluated the efficacy of HRS-1635 in participants with B-cell malignancy.

Conditions

B-cell Malignancy

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of adverse events.

  approximately 2 year

• DLT（Dose-limiting toxicity）

  approximately 23 days

Secondary Outcomes (12)

• Peak Concentration (Cmax)

  15 weeks after treatment initiation

• Area Under the Curve (AUC0-t, AUC0-inf)

  15 weeks after treatment initiation

• Half-life (t1/2)

  15 weeks after treatment initiation

• Apparent Clearance (CL/F)

  15 weeks after treatment initiation

• Apparent Volume of Distribution (Vz/F)

  15 weeks after treatment initiation.

Study Arms (1)

HRS-1635

EXPERIMENTAL

Drug: HRS-1635

Interventions

HRS-1635 DRUG

HRS-1635

HRS-1635

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years old;
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
• Expected survival time ≥ 12 weeks;
• Histologically or cytologically confirmed relapsed/refractory B-cell malignant tumor;
• 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;
• Participants voluntarily enroll in the study, sign the informed consent form, with good compliance and willingness to cooperate with follow-up procedures.

You may not qualify if:

• Tumor infiltration of the central nervous system;
• A history of other malignant tumors (excluding the study disease) within 2 years prior to the first administration of the study drug;
• A history of allogeneic hematopoietic stem cell transplantation or solid organ transplantation;
• Positive for hepatitis B surface antigen (HBsAg) at screening with evidence of viral replication confirmed by HBV-DNA test;
• Positive for hepatitis C virus antibody (HCV-Ab) at screening with evidence of viral replication confirmed by HCV-RNA test;
• Positive for human immunodeficiency virus (HIV) antigen/antibody test at screening;
• History of major surgery or severe trauma within 28 days prior to the first administration of the study drug;
• Presence of severe cardiovascular disease.;
• Persistent alcohol or drug abuse;
• Inability to take oral medication, or presence of severe gastrointestinal dysfunctional diseases, or history of surgery with severe impact on gastrointestinal function.
• Pregnant or lactating females.
• 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;

Sponsors & Collaborators

• Chengdu Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Sichuan Cancer Hospital

Chengdu, Sichuan, 610041, China

Location

Central Study Contacts

Bin Hu

CONTACT

+86-0518-82342973; bin.hu5@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: May 13, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: May 13, 2026

Record last verified: 2026-05

Locations

CN (1)