B-cell MalignancyPhase 1NCT07583212
Phase I Study of HRS-1635 in B-cell Malignancies
A Phase 1 study testing HRS-1635 in people with B-cell Malignancy, run by Chengdu Suncadia Medicine Co., Ltd. at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-cell Malignancy
- What is being tested?
- HRS-1635
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 30 Jun 2026to Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sichuan Cancer Hospital
Chengdu, Sichuan, 610041
Tongyu Lin
About this study
Official title: An Open-Label, Multicenter Phase I Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-1635 in Patients With B-Cell Malignancies.
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
- Being tested
- HRS-1635
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-1635Drug
HRS-1635
| Study group | Role | What they receive |
|---|---|---|
| HRS-1635 | Experimental | Not described Receives: Drug: HRS-1635 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of adverse events.
Measured: approximately 2 year
DLT（Dose-limiting toxicity）
Measured: approximately 23 days
Secondary outcomes (12)
Peak Concentration (Cmax)
Measured: 15 weeks after treatment initiation
Area Under the Curve (AUC0-t, AUC0-inf)
Measured: 15 weeks after treatment initiation
Half-life (t1/2)
Measured: 15 weeks after treatment initiation
Apparent Clearance (CL/F)
Measured: 15 weeks after treatment initiation
Apparent Volume of Distribution (Vz/F)
Measured: 15 weeks after treatment initiation.
Relative bioavaliability of HRS-1635 in the fed versus fasted state.
Measured: 48 hours post-dose
Objective Response Rate (ORR)
Measured: approximately 2 year
Time to Response (TTR)
Measured: approximately 2 year
Duration of Response (DoR)
Measured: approximately 2 year
Progression-Free Survival (PFS)
Measured: approximately 2 year
Overall Survival (OS)
Measured: approximately 2 year
Time to Peak Concentration (Tmax)
Measured: 15 weeks after treatment initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start30 Jun 2026
- Primary completionOct 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07583212
- Sponsor's protocol ID
- HRS-1635-101
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter Phase I Study on the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-1635 in Patients With B-Cell Malignancies.
- ClinicalTrials.gov ID
- NCT07583212
- Acronym / sponsor ID
- HRS-1635-101
- Conditions
- B-cell Malignancy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Chengdu Suncadia Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- Oct 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRS-1635 | Experimental | Drug: HRS-1635 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRS-1635HRS-1635 | Drug | HRS-1635 |
Primary outcome
Incidence and severity of adverse events.
Time frame: approximately 2 year
DLT（Dose-limiting toxicity）
Time frame: approximately 23 days
12 secondary outcomes
Peak Concentration (Cmax)
Time frame: 15 weeks after treatment initiation
Area Under the Curve (AUC0-t, AUC0-inf)
Time frame: 15 weeks after treatment initiation
Half-life (t1/2)
Time frame: 15 weeks after treatment initiation
Apparent Clearance (CL/F)
Time frame: 15 weeks after treatment initiation
Apparent Volume of Distribution (Vz/F)
Time frame: 15 weeks after treatment initiation.
Relative bioavaliability of HRS-1635 in the fed versus fasted state.
Time frame: 48 hours post-dose
Objective Response Rate (ORR)
Time frame: approximately 2 year
Time to Response (TTR)
Time frame: approximately 2 year
Duration of Response (DoR)
Time frame: approximately 2 year
Progression-Free Survival (PFS)
Time frame: approximately 2 year
Overall Survival (OS)
Time frame: approximately 2 year
Time to Peak Concentration (Tmax)
Time frame: 15 weeks after treatment initiation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRS-1635 in people with B-cell Malignancy, run by Chengdu Suncadia Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bin Hu (+86-0518-82342973, bin.hu5@hengrui.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of adverse events. (time frame: approximately 2 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.