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Receptor Tyrosine Kinase Inhibitor
Safety Study of SLC-391 in Subjects With Solid Tumors
Phase 1
Waitlist Available
Research Sponsored by SignalChem Lifesciences Corporation
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 2 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a new drug called SLC-391, which aims to block a protein that helps cancer cells grow. It is for patients with advanced solid tumors who haven't responded to other treatments. The study will check if the drug is safe and find the best dose to use.
Eligible Conditions
- Solid Tumors
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Maximum Tolerated Dose of SLC-391
Number of Participants with Adverse Events (AEs) as assessed by NCI-CTCAE v5.0
Secondary study objectives
Area under the plasma concentration versus time curve (AUC) of SLC-391
Maximum Observed Plasma Concentration (Cmax)
Number of Participants with Clinically Significant Changes From Baseline in Laboratory Parameters
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dose escalationExperimental Treatment1 Intervention
The starting dose will be 25 mg/day and subsequent doses will be determined after an internal review by Data Review Committee of all available safety, PK and PD data from the minimum required number of subjects who complete cycle 1. All dose-escalation decisions and the rationale for progressing to the next cohort will be documented.
A subject may continue treatment with SLC-391 in 21-day cycles until the treatment discontinuation criteria are met.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SLC-391
2022
Completed Phase 1
~60
Find a Location
Who is running the clinical trial?
SignalChem Lifesciences CorporationLead Sponsor
3 Previous Clinical Trials
120 Total Patients Enrolled
Zaihui Zhang, PhDStudy DirectorSignalChem Lifesciences Corporation
1 Previous Clinical Trials
92 Total Patients Enrolled