Menu
Recruiting NCT06403735

A Phase I Clinical Study of QLC1101 in Patients With Advanced Solid Tumors

Phase I Interventional Non-small Cell Lung Cancer Colorectal Cancer Pancreatic Cancer 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.
Who it may be relevant to
Registry conditions: Non-small Cell Lung Cancer, Colorectal Cancer, Pancreatic Cancer, Solid Tumor. Basic parameters: from 18 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
China
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 I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of QLC1101 Monotherapy in the Treatment of Patients With Advanced Solid Tumors Harboring a KRAS G12D Mutation

Overview

QLC1101 is a selective reversible inhibitor of KRAS G12D, with the dosage form of capsules and administration route of oral administration. In the first-in-humans (FIH) study, the sponsor will explore the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of QLC1101 in subjects with advanced solid tumors harboring a KRAS G12D mutation. The FIH study includes dose escalation, PK expansion, and efficacy expansion.

Interventions

  • Drug QLC1101
    QLC1101 is an innovative small molecule inhibitor targeting KRAS G12D with independent intellectual property rights developed by Qilu Pharmaceutical Co., Ltd.QLC1101 can prevent GTP/GDP nucleotide exchange and/or the formation of KRAS G12D/GTP/RAF1 complex and inhibit mutant KRAS-dependent signal transduction by specifically binding to the KRAS G12D target, thereby inhibiting the generation of KRAS G12D mutant tumors.

Primary outcome measures

  • Dose limiting toxicity (DLT) [Time frame: 25 days after the first dose]
  • MTD (or MAD) [Time frame: 1 year]
  • RP2D [Time frame: 1.5 years]
Secondary outcome measures (2)
  • Preliminary efficacy endpoints [Time frame: 3 years]
  • Preliminary efficacy endpoints [Time frame: 3 years]

Eligibility criteria

Inclusion criteria

  • Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors harboring a KRAS G12D mutation. Sign the ICF.
  • Those who fail or are unable to tolerate standard treatment, lack standard treatment, or refuse to receive standard treatment;
  • Those who are able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormality that may alter absorption;
  • Subjects who have at least one measurable lesion documented by computed tomography (CT) and/or magnetic resonance imaging (MRI) as confirmed by the investigator per the RECIST v1.1 criteria.
  • ECOG PS score: 0 or 1;
  • Expected survival time ≥ 3 months;
  • Adequate organ function at screening:

Exclusion criteria

  • Previously treated with inhibitors against KRAS G12D mutation;
  • The period of time prior to the first dose of investigational product should be at least 28 days from previous treatment or at least 5 half-lives
  • Known immediate or delayed hypersensitivity or idiosyncratic reaction to the ingredients of the preparation used in the trial;
  • Presence of other active malignant tumors in addition to primary tumors;
  • Presence of serious lung diseases at screening;
  • Clinically significant gastrointestinal disorders or other conditions that seriously interfere with drug absorption;
  • Severe hereditary or acquired hemorrhagic diathesis or coagulation disorders;
  • Complicated with clinically significant cardiovascular and cerebrovascular disorders;
  • History of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation);
  • Presence of known mental disorders, epilepsy, dementia, or alcohol and drug abuse that may affect the compliance with study requirements;
  • the investigator determines that participation in the study is not in the best interest of the subject.

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

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 5 centers
  • The First Affiliated Hospital of Guangdong Pharmaceutical University — Guangzhou
  • Harbin Medical university cancer hospital — Harbin
  • Jiangxi Cancer Hospital — Nanchang
  • Shanghai east hospital — Shanghai
  • Yunnan Cancer Hospital — Kunming

Identifiers

NCT: NCT06403735 · QLC1101-101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗