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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
Sponsor: Qilu Pharmaceutical Co., Ltd.
Summary
A Phase Ib/II 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. The study includes Phase Ib (combination therapy with dose escalation stage) and Phase II (expansion stage). The study will includes a total of 4 cohorts: Phase Ib will enroll subjects in 4 cohorts (cohorts 1-4). Subjects will be allocated to appropriate cohorts by the investigator according to specific indications and treated with the corresponding combination regimen for safety and tolerability assessment. The Bayesian optimal interval (BOIN) design will be used for dose escalation and MTD determination. In Phase II, according to the results of the Phase Ib and SMC decision, 1-2 appropriate dose groups will be selected. In the dose group(s), the sample size (including subjects in the dose escalation stage) will be increased to 20 for each indication according to the cohort for expansion to further evaluate the efficacy of QLC1101 combination therapy in the treatment of subjects with advanced solid tumors harboring KRAS G12D mutations
Official title: A Phase Ib/II 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2025-06
Completion Date
2027-06
Last Updated
2025-04-29
Healthy Volunteers
No
Conditions
Interventions
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®
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®)
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)
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