RecruitingPhase 1NCT06403735

A Phase I Clinical Study of QLC1101 in Patients With Advanced Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLC1101 Monotherapy in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation


Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

250 participants

Start Date

Apr 25, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

QLC1101 is a selective reversible inhibitor of KRAS G12D, with the dosage form of capsules and administration route of oral administration. In the first-in-humans (FIH) study, the sponsor will explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of QLC1101 in subjects with advanced solid tumors harboring a KRAS G12D mutation. The FIH study includes dose escalation, PK expansion, and efficacy expansion.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase I safety trial of an experimental oral drug called QLC1101, which targets a specific cancer mutation called KRAS G12D. It is designed for patients with advanced solid tumors who have this mutation and for whom standard treatments have not worked. **You may be eligible if...** - You are 18 or older with advanced (metastatic or inoperable) solid tumor cancer - Your tumor has been confirmed to have a KRAS G12D mutation - Standard treatment options have failed, are unavailable, or you cannot tolerate them - You have at least one measurable lesion on imaging - Your general health score is 0 or 1 (fully active or able to do light work) - Your blood counts and organ function are within acceptable ranges **You may NOT be eligible if...** - You have previously been treated with a KRAS G12D inhibitor - You have had another active cancer at the same time - You have serious lung, heart, or gastrointestinal conditions that could affect the drug - You are pregnant or could become pregnant without contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGQLC1101

QLC1101 is an innovative small molecule inhibitor targeting KRAS G12D with independent intellectual property rights developed by Qilu Pharmaceutical Co., Ltd.QLC1101 can prevent GTP/GDP nucleotide exchange and/or the formation of KRAS G12D/GTP/RAF1 complex and inhibit mutant KRAS-dependent signal transduction by specifically binding to the KRAS G12D target, thereby inhibiting the generation of KRAS G12D mutant tumors.


Locations(5)

The First Affiliated Hospital of Guangdong Pharmaceutical University

Guangzhou, Guangdong, China

Harbin Medical university cancer hospital

Harbin, Heilongjiang, China

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Shanghai east hospital

Shanghai, Shanghai Municipality, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

View Full Details on ClinicalTrials.gov

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NCT06403735


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