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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-30

Study Completion Date

2027-06-30

Brief Summary

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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

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Detailed Description

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Conditions

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Solid Tumor

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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®

Intervention Type 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®)

Intervention Type 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)

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No