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

Phase 1

Not yet recruiting

• Conditions: Solid Tumor
• Interventions: Drug: QLC1101+QL1203; Drug: QLC1101+QL2107; Drug: QLC1101+QL1706; Drug: QLC1101+docetaxel

• Registration Number: NCT06949761
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-22
• Study First Submitted QC: 2025-04-22
• Last Update Submitted: 2025-04-22
• Study First Posted: 2025-04-29
• Last Update Posted: 2025-04-29
• Study Start: 2025-06
• Primary Completion: 2026-09
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QLC1101+QL1203	QLC1101+QL1203	-
QLC1101+QL2107	QLC1101+QL2107	-
QLC1101+QL1706	QLC1101+QL1706	-
QLC1101+docetaxel	QLC1101+docetaxel	-

Primary Outcome Measures

Name	Time	Method
adverse events	from first dose to 90 days after last dose	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