Evaluating QLS31903 for advanced solid tumors
Official title: A Phase 1 Study to Investigate the Safety, Tolerability，Pharmacokinetics, Immunogenicity and Preliminary Effectiveness of QLS31903 Injection in Subjects With Advanced Solid Tumors
Run by Qilu Pharmaceutical Co., Ltd. · NCT05823285 · Data updated 2026-11-12
This study is testing a new drug called QLS31903 to see if it can help people with advanced solid tumors who haven't had success with other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Qilu Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Status | Recruiting |
| Started | March 22, 2023 |
| Main results expected | June 15, 2025 |
| Study ends | June 15, 2027 |
| Registry record updated | April 21, 2023 |
| Trial ID | NCT05823285 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with confirmed advanced solid tumors who have failed standard treatments.
✕Probably not a fit
Patients with prior targeted treatment for GPC3 or those with active CNS metastasis may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the safety, pharmacokinetics, immunogenicity, and efficacy of QLS31903 in patients with advanced solid tumors. It is an interventional Phase 1 trial that focuses on patients who have not responded to standard treatments or are intolerant to them. Participants will receive QLS31903, and their responses will be monitored to gather data on the drug's performance and safety profile.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have limited alternatives.
How similar studies have gone: While this approach is novel, similar studies targeting advanced solid tumors have shown promise in the past.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Fudan Zhongshan Hospital
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Study coordinator: Yan Chen, PhD
- Email: yan12.chen@qilu-pharma.com
- Phone: 8617843558626
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.