SKL27969 for Cancer

Recruiting in Palo Alto (17 mi)

+3 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: SK Life Science, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing a new drug called SKL27969 to see if it is safe and can help reduce tumors in patients with specific types of cancer. The study will also look at how the drug moves through the body.

Eligibility Criteria

Adults with advanced solid tumors that are non-resectable or metastatic and have not responded to standard treatments. Participants must have completed certain prior therapies, be in stable health with a life expectancy of at least 3 months, and agree to use effective contraception. Exclusions include recent heart issues, major surgeries, active infections requiring IV antibiotics, pregnancy or breastfeeding, and known allergies to the drug's components.

Inclusion Criteria

Willing and able to comply with all protocol required visits and assessments

Hematological and biochemical indices within specified ranges

Willing to provide written, voluntary informed consent prior to any study-specific procedures

+12 more

Exclusion Criteria

Prior participation in another clinical study with PRMT5 inhibitor(s)

History of alcohol or drug abuse for the past 5 years

I currently have an infection that needs IV antibiotics.

+12 more

Participant Groups

The trial is testing SKL27969 for safety and tolerability (Part 1) to find the highest dose patients can take without serious side effects (MTD/RP2D). In Part 2, they're looking at how well it works against tumors. The study has two phases: increasing doses to test safety first then expanding the dose group size once safe levels are found.

2Treatment groups

Experimental Treatment

Group I: Part 2: Dose Expansion PhaseExperimental Treatment1 Intervention

Part 2 includes tumor-specific expansion cohorts utilizing the MTD/RP2D doses (determined from Part 1) to further explore safety and anti-tumor activity of SKL27969, in addition to the PK and PD from the patients with the selected tumor types.

Group II: Part 1: Dose Escalation PhaseExperimental Treatment1 Intervention

Part 1 is a dose escalation phase to evaluate the safety, tolerability, and define the MTD and RP2D. Part 1 is a 3+3 design.