Testing QLC1101 for advanced solid tumors with KRAS G12D mutation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates QLC1101, a selective reversible inhibitor targeting the KRAS G12D mutation, in patients with advanced solid tumors. The study focuses on assessing the safety, tolerability, pharmacokinetics, and preliminary efficacy of the drug through a dose escalation and expansion approach. Participants will receive oral capsules of QLC1101, and the study aims to determine the drug's effectiveness in those who have not responded to standard treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with histologically confirmed advanced (metastatic or unresectable) solid tumors harboring a KRAS G12D mutation. Sign the ICF.
2. Those who fail or are unable to tolerate standard treatment, lack standard treatment, or refuse to receive standard treatment;
3. Those who are able to swallow and retain oral medication and must not have any clinically significant gastrointestinal abnormality that may alter absorption;
4. 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.
5. ECOG PS score: 0 or 1;
6. Expected survival time ≥ 3 months;
7. Adequate organ function at screening:

Exclusion Criteria:

1. Previously treated with inhibitors against KRAS G12D mutation;
2. 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
3. Known immediate or delayed hypersensitivity or idiosyncratic reaction to the ingredients of the preparation used in the trial;
4. Presence of other active malignant tumors in addition to primary tumors;
5. Presence of serious lung diseases at screening;
6. Clinically significant gastrointestinal disorders or other conditions that seriously interfere with drug absorption;
7. Severe hereditary or acquired hemorrhagic diathesis or coagulation disorders;
8. Complicated with clinically significant cardiovascular and cerebrovascular disorders;
9. History of allogeneic hematopoietic stem cell transplantation or organ transplantation (except corneal transplantation);
10. Presence of known mental disorders, epilepsy, dementia, or alcohol and drug abuse that may affect the compliance with study requirements;
11. the investigator determines that participation in the study is not in the best interest of the subject.

Where it's running

• Shanghai east hospital
  Shanghai, Shanghai Municipality, China Recruiting
• The First Affiliated Hospital of Guangdong Pharmaceutical University
  Guangzhou, Guangdong, China Not yet recruiting
• Harbin Medical university cancer hospital
  Harbin, Heilongjiang, China Not yet recruiting
• Jiangxi Cancer Hospital
  Nanchang, Jiangxi, China Not yet recruiting
• Yunnan Cancer Hospital
  Kunming, Yunnan, China Not yet recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• IBI3028 in advanced solid tumors

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  Recruiting Phase 1 Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Tianjin, Tianjin Municipality · NCT07589205

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• Finding a suitable dose of ASP5834 for adults with solid tumors

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• Evaluating zanidatamab for HER2-expressing tumors

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.