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

Qilu Pharmaceutical

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Solid Tumor

Treatments: Drug: QLC1101+docetaxel; Drug: QLC1101+QL1706; Drug: QLC1101+QL2107; Drug: QLC1101+QL1203

Study type: Interventional

Funder types: Industry

Identifiers

NCT06949761

QLC1101-201

Details and patient eligibility

About

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

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

240 participants in 4 patient groups

QLC1101+QL1203

Experimental group

Treatment:

Drug: QLC1101+QL1203

QLC1101+QL2107

Experimental group

Treatment:

Drug: QLC1101+QL2107

QLC1101+QL1706

Experimental group

Treatment:

Drug: QLC1101+QL1706

QLC1101+docetaxel

Experimental group

Treatment:

Drug: QLC1101+docetaxel