Phase I Study of HRS-1635 in B-cell Malignancies
ConditionB-cell Malignancy
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorChengdu Suncadia Medicine Co., Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
HRS-1635
DrugHRS-1635
Treatment groups
180 Participants
are divided into 1 treatment groupGroup A: HRS-1635Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence and severity of adverse events.
Time frame
approximately 2 year2
DLT（Dose-limiting toxicity）
Time frame
approximately 23 daysSecondary outcomes
1
Peak Concentration (Cmax)
Time frame
15 weeks after treatment initiation2
Area Under the Curve (AUC0-t, AUC0-inf)
Time frame
15 weeks after treatment initiation3
Half-life (t1/2)
Time frame
15 weeks after treatment initiation4
Apparent Clearance (CL/F)
Time frame
15 weeks after treatment initiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov