Study of QLS31905 and/or QL1706 Combination With Chemotherapy in the Advanced Malignant Solid Tumors

Last updated: June 1, 2024
Sponsor: Qilu Pharmaceutical Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Neoplasms

Treatment

Capecitabine

Chemotherapy drug

QL1706

Clinical Study ID

NCT06446388
QLS31905-202
  • Ages 18-75
  • All Genders

Study Summary

This study aims to evaluate the efficacy and safety of QLS31905 and/or QL1706 plus chemotherapy in patients with Claudin18.2-positive advanced solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects voluntarily participate in the study and sign the informed consent form;

  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;

  • Expected survival time ≥ 3 months;

  • Histologically or cytologically confirmed locally advanced unresectable ormetastatic solid tumors;

  • No prior systemic anti-tumor treatment for locally advanced unresectable ormetastatic disease;

  • Tumor tissue samples determined to be positive for Claudin18.2 byimmunohistochemistry (IHC);

  • At least one measurable lesion per RECIST v1.1;

  • Patients with adequate cardiac, liver, renal function, etc.

Exclusion

Exclusion Criteria:

  • History of malignancies other than the target cancer within 5 years prior to thefirst dose of the investigational product ;

  • Underwent major organ surgery (excluding needle biopsy) or had significant traumawithin 28 days prior to enrollment, or requires elective surgery during the study;

  • Known central nervous system metastases;

  • Patients with hepatitis B; patients with hepatitis C; patients who test positive forsyphilis, or patients with a known history of HIV or positive HIV screening test;Patients with a known history of psychoactive drug abuse, alcohol abuse, orsubstance abuse;

  • Patients with added risks associated with the study or may interfere with theinterpretation of study results as determined by the investigator, or deemedunsuitable by the investigator and/or sponsor.

Study Design

Total Participants: 360
Treatment Group(s): 7
Primary Treatment: Capecitabine
Phase: 2
Study Start date:
June 30, 2024
Estimated Completion Date:
December 01, 2027

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, Beijing 100142
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.