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SKL27969 for Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by SK Life Science, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Male and female patients at least 18 years of age at the time of informed consent

Prior treatment required for specific diagnoses that are histologically and molecularly confirmed

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial is testing a new drug, SKL27969, to see if it is safe and effective against cancer.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Specific side effects of SKL27969 aren't listed but generally may include typical reactions seen with cancer drugs such as nausea, fatigue, risk of infection due to lowered blood counts; organ inflammation; allergic reactions; potential impact on liver function; skin sensitivity requiring sun protection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My diagnosis was confirmed with specific tests and I have received prior treatment.

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My cancer has grown despite recent treatment, and it can be measured by scans.

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My scans show my cancer is getting worse but I am expected to live for several more months.

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My cancer is advanced, cannot be surgically removed, and does not respond to standard treatments.

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I am fully active or can carry out light work.

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My liver, kidney, and heart are functioning within normal ranges.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Part 1 (Dose Escalation Phase) - Number of participants with abnormal assessments

Part 1 (Dose Escalation Phase) - Number of participants with dose limiting toxicities

Part 1 (Dose Escalation Phase) - Numbers of participants with adverse events, dose interruptions and modifications

+3 more

Secondary outcome measures

Part 1 (Dose Escalation Phase) - Number of participants with partial response data

Part 1 (Dose Escalation Phase) - Pharmacokinetics of SKL27969

Part 2 (Dose Expansion Phase) - Number of participants with adverse events, dose interruptions and modifications

+1 more

Trial Design

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.

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

SK Life Science, Inc.Lead Sponsor

40 Previous Clinical Trials

8,830 Total Patients Enrolled

Vijaykumar Vashi, PhDStudy ChairSK Life Science, Inc.

1 Previous Clinical Trials

111 Total Patients Enrolled

Media Library

SKL27969 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05388435 — Phase 1 & 2

Solid Tumors Research Study Groups: Part 1: Dose Escalation Phase, Part 2: Dose Expansion Phase

Solid Tumors Clinical Trial 2023: SKL27969 Highlights & Side Effects. Trial Name: NCT05388435 — Phase 1 & 2

SKL27969 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05388435 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this medical trial currently seeking participants?

"According to the clinicaltrials.gov portal, this research effort is actively seeking participants and was initially published on September 12th 2022 with its latest iteration arriving October 7th 2022."

Answered by AI

What ultimate goal is this research aiming to achieve?

"Per the trial sponsor, SK Life Science Inc., their principal endpoint for this one-year study will be evaluating overall survival in Part 2 (Dose Expansion Phase). Also being assessed are secondary outcomes such as progression-free survival from day 1 of treatment to disease recurrence according to RECIST version 1.1 or RANO in Part 1 and any adverse events, dose interruptions/modifications since signing of Informed Consent Form until discontinuation/survival follow up completion also in Part2."

Answered by AI

How many participants are currently enlisted in this clinical trial?

"Affirmative. Clinicaltrials.gov illustrates that this clinical trial, with its debut occuring on September 12th 2022, is presently seeking volunteers. There will be a total of 96 participants at one site in particular."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients

2022. "Safety, Tolerability, PK/PD & Preliminary Efficacy of SKL27969 in Advanced Solid Tumors Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05388435.