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

NCT06949761 | Not Yet Recruiting Phase 1

• 1 other identifier: QLC1101-201
• Study Type: interventional
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• adverse events

  any untoward medical occurrence in a subject who received an investigational product, which can be manifested as any symptoms, signs, diseases, or laboratory test abnormalities, and do not necessarily have a causal relationship with the investigational product

  from first dose to 90 days after last dose

Study Arms (4)

QLC1101+QL1203

EXPERIMENTAL

Drug: QLC1101+QL1203

QLC1101+QL2107

EXPERIMENTAL

Drug: QLC1101+QL2107

QLC1101+QL1706

EXPERIMENTAL

Drug: QLC1101+QL1706

QLC1101+docetaxel

EXPERIMENTAL

Drug: QLC1101+docetaxel

Interventions

QLC1101+QL1203 DRUG

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+QL1203

QLC1101+QL2107 DRUG

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+QL2107

QLC1101+QL1706 DRUG

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+QL1706

QLC1101+docetaxel DRUG

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

QLC1101+docetaxel

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects confirmed advanced (metastatic or unresectable) solid tumors with KRAS G12D mutations.
• Subjects who have failed or are unable to tolerate standard therapy, have no standard therapy, or refuse to receive standard therapy
• The investigator confirms that the subject has at least one measurable lesion recorded by CT and/or MRI according to RECIST v1.1
• ECOG PS score: 0 or 1

You may not qualify if:

• Subjects who have been previously treated with inhibitors for KRAS G12D mutations
• Subjects with known immediate or delayed hypersensitivity or idiosyncratic reaction to the components of the drug products used in the study
• Subjects with known or symptomatic active central nervous system (CNS) metastases or carcinomatous meningitis at screening

Sponsors & Collaborators

• Qilu Pharmaceutical Co., Ltd.: lead

Central Study Contacts

caicun Zhou, PhD

CONTACT

13301825532; caicunzhoudr@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2025
• First Posted: April 29, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 29, 2025

Record last verified: 2025-04