Safety, Tolerability and Pharmacokinetics Study of QLH11906 in Patients With Advanced Solid Tumors Harboring MAPK Pathway Alterations.

  • STATUS
    Recruiting
  • End date
    Jul 1, 2025
  • participants needed
    40
  • sponsor
    Qilu Pharmaceutical Co., Ltd.
Updated on 4 October 2022

Summary

This is an open label, phase 1 clinical study to evaluate the safety and tolerability of different doses of QLH11906 monotherapy in patients with relapsed/refractory, unresectable locally advanced or metastatic advanced solid tumors with abnormal MAPK pathway, and determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD, if MTD cannot be determined) and Recommended Dose in Phase II Clinical Studies (Recommended Phase II Dose, RP2D).

Details
Condition Advanced Solid Tumors Harboring MAPK Pathway Alterations
Treatment QLH11906
Clinical Study IdentifierNCT05488821
SponsorQilu Pharmaceutical Co., Ltd.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

The subjects participated voluntarily, signed the informed consent, and were able to abide by the research procedures
Subjects with advanced (metastatic or unresectable) solid tumors with histologically confirmed MAPK signaling pathway alteration
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
Subjects are able to swallow and retain oral medication without any clinically significant gastrointestinal abnormalities that alter absorption
Subjects (including women and men) agree to use effective contraception for contraception from the time of signing the informed consent form to 180 days after the last use of the study drug. Female subjects of childbearing age cannot be pregnant or breastfeeding

Exclusion Criteria

Subjects received systemic anticancer therapy within 2 weeks prior to the first dose
Subjects received radical radiotherapy within 4 weeks before the first administration, or received local palliative radiotherapy for bone metastases within 1 week
Subjects who have received inhibitors or inducers of CYP3A4 within 1 week before the first dose; or within 5 half-lives of the drug; or subjects who need to continue to receive these drugs during the study period
Active bacterial, fungal, or viral infection requiring systemic therapy within 1 week prior to the first dose
Subjects with symptomatic central nervous system (CNS) metastases and/or cancerous meningitis
Cardiovascular and cerebrovascular diseases with clinical significance
Clinically uncontrollable serous effusion (eg, pleural effusion that cannot be controlled by drainage or other methods)
Active gastrointestinal disease or other conditions that significantly interfere with drug absorption
Known immediate or delayed hypersensitivity reactions or idiosyncratic reactions to the investigational treatment-related chemotherapeutic drugs and their excipients
Human immunodeficiency virus (HIV) positive test result and Treponema pallidum antibody positive
Hepatitis B virus surface antigen (HBsAg) positive and viral deoxyribonucleic acid (HBV DNA) > 2000 IU/ml or 104 copies/ml (only the centers that can perform qualitative examination, the HBV DNA test result is positive or high detection limit); hepatitis C virus antibody positive and viral ribonucleic acid (HCV RNA) positive
Other malignant tumors occurred within 2 years before study enrollment. (Except: Bowen's disease; cured basal cell or squamous cell skin cancer; prostate cancer with a Gleason score of 6; treated cervical carcinoma in situ.)
Pregnant or lactating women
Any pre-existing serious or unstable disease (except for the above-mentioned malignant tumors), mental disease or any disease or medical condition that the investigator considers may interfere with the subject's safety, obtaining informed consent, or complying with research procedures
Concurrent participation in other clinical trials using experimental therapies
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