SLC-391 for 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

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 more

Awards & 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

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