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200mg QD for Blood Cancers

Phase 1
Recruiting
Led By Chongyuan Xu
Research Sponsored by Hutchmed
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up until to disease progression/relapse or initiate new anti-tumor therapies will continue to attend os follow-up visits every 2 months until death, patient withdrawal, loss to follow-up or end of study, whichever comes first, maybe assessed up to 42 months
Awards & highlights
No Placebo-Only Group

Summary

This is a Phase 1, multicenter, open-label clinical study of HMPL-506 administered orally in the treatment of hematological malignancies. Only eligible patients who provide the signed informed consent form (ICF) can be enrolled in this study. The study consists of two phases, i.e., a dose escalation phase and a dose expansion phase. The study is expected to enroll approximately 60 to 98 patients, including approximately 30 to 38 patients in the dose escalation phase and approximately 30 to 60 patients in the dose expansion phase.

Eligible Conditions
  • Blood Cancers

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until to disease progression/relapse or initiate new anti-tumor therapies will continue to attend os follow-up visits every 2 months until death, patient withdrawal, loss to follow-up or end of study, whichever comes first, maybe assessed up to 42 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and until to disease progression/relapse or initiate new anti-tumor therapies will continue to attend os follow-up visits every 2 months until death, patient withdrawal, loss to follow-up or end of study, whichever comes first, maybe assessed up to 42 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy evaluation: Anti-tumor efficacy evaluation.
Safety evaluation: Incidence of serious adverse events (SAEs) and Relationship to Study Drug
Safety evaluation: Safety Incidence of Dose-limiting Toxicity (DLTs)
Secondary study objectives
Adverse Events Associated with Dose Modifications
Complete response (CR)+ Complete response with partial recovery of hematology (CRh) rate
Complete response rate (CR rate)
+16 more
Other study objectives
Evaluate the changes of the Pharmacodynamic Biomarker

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups
Experimental Treatment
Group I: 50mg QDExperimental Treatment1 Intervention
The starting dose of 50 mg QD will be escalated using the accelerated titration design in the first enrolled subject. If no DLT is observed and no Grade 2 or higher investigational product-related adverse events occur during the DLT observation period at the dose 50mg QD, the dose can be escalated to 100 mg QD, and the mTPI-2 design will be used for dose escalation. The dose will be escalated based on available efficacy and safety data in conjunction with preclinical Pharmacodynamics, Pharmacokinetic (PK) and Pharmacodynamics (PD) data.
Group II: 400mg QDExperimental Treatment1 Intervention
If no DLT is observed during the DLT observation period at the dose 300mg QD, the dose can be escalated to 400 mg QD and the mTPI-2 design will be used for dose escalation. Three patients will be enrolled first at each dose level. When all patients treated at one dose level complete the DLT evaluation, additional 3 patients will be enrolled in the next cohort treated at the determined dose level following the rules. If more than one patient is undergoing screening when the last patient in this cohort (i.e., the third patient) starts treatment, a maximum of 3 patients can be enrolled in this cohort based on the assessment conducted by the sponsor and investigator. The dose will be escalated based on available efficacy and safety data in conjunction with preclinical pharmacodynamics, PK and PD data.
Group III: 300mg QDExperimental Treatment1 Intervention
If no DLT is observed during the DLT observation period at the dose 200mg QD, the dose can be escalated to 300 mg QD and the mTPI-2 design will be used for dose escalation. Three patients will be enrolled first at each dose level. When all patients treated at one dose level complete the DLT evaluation, additional 3 patients will be enrolled in the next cohort treated at the determined dose level following the rules. If more than one patient is undergoing screening when the last patient in this cohort (i.e., the third patient) starts treatment, a maximum of 3 patients can be enrolled in this cohort based on the assessment conducted by the sponsor and investigator. The dose will be escalated based on available efficacy and safety data in conjunction with preclinical pharmacodynamics, PK and PD data.
Group IV: 200mg QDExperimental Treatment1 Intervention
If no DLT is observed during the DLT observation period at the dose 100mg QD, the dose can be escalated to 200 mg QD, and the mTPI-2 design will be used for dose escalation. Three patients will be enrolled first at each dose level. When all patients treated at one dose level complete the DLT evaluation, additional 3 patients will be enrolled in the next cohort treated at the determined dose level following the rules. If more than one patient is undergoing screening when the last patient in this cohort (i.e., the third patient) starts treatment, a maximum of 3 patients can be enrolled in this cohort based on the assessment conducted by the sponsor and investigator. The dose will be escalated based on available efficacy and safety data in conjunction with preclinical pharmacodynamics, PK and PD data.
Group V: 100mg QDExperimental Treatment1 Intervention
If no DLT is observed and no Grade 2 or higher investigational product-related adverse events occur during the DLT observation period at the dose 50mg QD, the dose can be escalated to 100 mg QD, and the mTPI-2 design will be used for dose escalation. Three patients will be enrolled first at this dose level. When all patients treated at one dose level complete the DLT evaluation, if more than one patient is undergoing screening when the last patient in this cohort (i.e., the third patient) starts treatment, a maximum of 3 patients can be enrolled in this cohort based on the assessment conducted by the sponsor and investigator. The dose will be escalated based on available efficacy and safety data in conjunction with preclinical pharmacodynamics, PK and PD data.

Find a Location

Who is running the clinical trial?

HutchmedLead Sponsor
34 Previous Clinical Trials
6,331 Total Patients Enrolled
Chongyuan XuPrincipal InvestigatorNanfang Hospital, Southern Medical University
Yu ZhuPrincipal InvestigatorThe First Affiliated Hospital with Nanjing Medical University
~65 spots leftby Oct 2027
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