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

Colorectal, Cancer Pancreatic Cancer Non-small Cell Lung Cancer Solid Tumor

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

Inclusion Criteria7

Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors harboring a KRAS G12D mutation. Sign the ICF.
Those who fail or are unable to tolerate standard treatment, lack standard treatment, or refuse to receive standard treatment;
Those who are able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormality that may alter absorption;
Subjects who have at least one measurable lesion documented by computed tomography (CT) and/or magnetic resonance imaging (MRI) as confirmed by the investigator per the RECIST v1.1 criteria.
ECOG PS score: 0 or 1;
Expected survival time ≥ 3 months;
Adequate organ function at screening:

Exclusion Criteria11

Previously treated with inhibitors against KRAS G12D mutation;
The period of time prior to the first dose of investigational product should be at least 28 days from previous treatment or at least 5 half-lives
Known immediate or delayed hypersensitivity or idiosyncratic reaction to the ingredients of the preparation used in the trial;
Presence of other active malignant tumors in addition to primary tumors;
Presence of serious lung diseases at screening;
Clinically significant gastrointestinal disorders or other conditions that seriously interfere with drug absorption;
Severe hereditary or acquired hemorrhagic diathesis or coagulation disorders;
Complicated with clinically significant cardiovascular and cerebrovascular disorders;
History of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation);
Presence of known mental disorders, epilepsy, dementia, or alcohol and drug abuse that may affect the compliance with study requirements;
the investigator determines that participation in the study is not in the best interest of the subject.

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.