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SPH5030 tablets for Solid Tumors

Phase < 1
Recruiting
Led By Binghe Xu
Research Sponsored by Shanghai Pharmaceuticals Holding Co., Ltd
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 up to 2 years
Awards & highlights

Summary

To evaluate the safety and tolerability of SPH5030 tablets in subjects with HER2-positive advanced solid tumors

Eligible Conditions
  • Solid Tumors

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose-limiting toxicity (DLT)
Maximum tolerated dose（MTD）
Number of patients with adverse events
Secondary study objectives
6-month Progression-free Survival (6mPFS)
Accumulation ratio of area under the serum concentration-time curve (Rac_AUC) of the Dosing Interval (0-14D) of SPH5030
Accumulation ratio of maximum serum concentration (Rac_Cmax) of SPH5030
+14 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: SPH5030 tabletsExperimental Treatment1 Intervention
Subjects will take SPH5030 tablets orally on an empty stomach once or twice a day. Each subject will receive only one corresponding dose, and there were five dose groups: 50mg/ d, 100mg/ d, 200mg/ d, 300mg/ d and 400mg/ d.

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Who is running the clinical trial?

Shanghai Pharmaceuticals Holding Co., LtdLead Sponsor
41 Previous Clinical Trials
5,203 Total Patients Enrolled
Binghe XuPrincipal InvestigatorCancer Institute and Hospital, Chinese Academy of Medical Sciences
14 Previous Clinical Trials
6,093 Total Patients Enrolled
~10 spots leftby Dec 2024
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