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A Study Evaluates the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLS31903 in Advanced Solid Tumor Patients

Recruiting
18 years of age
Both
Phase 1

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Overview

The purpose of the study is to evaluate safety, pharmacokinetics,immunogenicity and efficacy of QLS31903 alone in the treatment of advanced cancer.

Eligibility

Key Inclusion Criteria:

  • 18 years or older, 40kg or heavier
  • Histologically or cytologically confirmed diagnosis of advanced solid tumor (For phase 1b, patients must have solid tumor with GPC3+ )
  • Standard treatment failed or standard treatment intolerant, no standard treatment
  • Adequate hepatic, hematologic, and renal function

Key Exclusion Criteria:

  • Anti-tumor treatment within 4 weeks prior to the first QLS31903 administration,except a few specific conditions
  • Other clinical trial within 4 weeks prior to the first QLS31903 administration
  • Receipt of a live or live attenuated vaccine within 30 days prior to the first QLS31903 administration
  • Prior treatment targeted on GPC3
  • HBsAg/HBcAb positive and HBV-DNA>10,000 copy/mL;HCV-Ab positive and HCV-RNA>1,000 copy/mL
  • CNS metastasis (except asymptomatic brain metastases or symptomatic brain metastases after treatment stable for more than 4 weeks) and/or carcinomatous meningitis or leptomeningeal disease

Study details

Advanced Solid Tumors

NCT05823285

Qilu Pharmaceutical Co., Ltd.

26 January 2024

Step 1 Get in touch with the nearest study center
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Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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