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Not yet recruiting NCT06949761

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 I / Phase II Interventional Solid Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QLC1101+QL1203, QLC1101+QL2107, QLC1101+QL1706, QLC1101+docetaxel.
Who it may be relevant to
Registry conditions: Solid Tumor. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • Drug 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®
  • 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®)
  • 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)
  • 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

Primary outcome measures

  • adverse events [Time frame: from first dose to 90 days after last dose]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06949761 · QLC1101-201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗