Phase I Study of HRS-1635 in B-cell Malignancies
ConditionB-cell Malignancy
Trial statusNot yet recruiting
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
This trial is not recruiting at the moment. You can still explore other options: