A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of QLC1101 in Combination With Other Therapies in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation

PHASE1/PHASE2Not yet recruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

September 30, 2026

Study Completion Date

June 30, 2027

Conditions
Solid Tumor
Interventions
DRUG

QLC1101+QL1203

QLC1101 is an innovative small molecule inhibitor targeting KRAS G12D with independent intellectual property rights developed by Qilu Pharmaceutical Co., Ltd.;QL1203, developed by Qilu Pharmaceutical Co., Ltd., is a recombinant anti-EGFR fully human monoclonal antibody injection and a biosimilar to Vectibix®

DRUG

QLC1101+QL2107

QLC1101 is an innovative small molecule inhibitor targeting KRAS G12D with independent intellectual property rights developed by Qilu Pharmaceutical Co., Ltd.;QL2107 developed by Qilu Pharmaceutical Co., Ltd. is a potential biosimilar to Pembrolizumab (Keytruda®)

DRUG

QLC1101+QL1706

QLC1101 is an innovative small molecule inhibitor targeting KRAS G12D with independent intellectual property rights developed by Qilu Pharmaceutical Co., Ltd.;QL1706 Injection (QL1706) is a combination antibody developed by Qilu Pharmaceutical Co., Ltd. It consists of two full-length immunoglobulin G (IgG) antibodies: anti-PD-1 monoclonal antibody (hereafter referred to as anti-PD-1) and anti-CTLA-4 monoclonal antibody (hereafter referred to as anti-CTLA-4)

DRUG

QLC1101+docetaxel

QLC1101 is an innovative small molecule inhibitor targeting KRAS G12D with independent intellectual property rights developed by Qilu Pharmaceutical Co., Ltd.;Docetaxel is a tubulin binding agent that prevents cell division by stabilizing microtubule structure and leads to apoptosis

All Listed Sponsors
lead

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

NCT06949761 - A Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of QLC1101 in Combination With Other Therapies in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation | Biotech Hunter | Biotech Hunter