Evaluating QLS31903 for advanced solid tumors
A Phase 1 Study to Investigate the Safety, Tolerability，Pharmacokinetics, Immunogenicity and Preliminary Effectiveness of QLS31903 Injection in Subjects With Advanced Solid Tumors
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 |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qilu Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05823285 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with confirmed advanced solid tumors who have failed standard treatments.
Not a fit: Patients with prior targeted treatment for GPC3 or those with active CNS metastasis may not benefit from this study.
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 performed: While this approach is novel, similar studies targeting advanced solid tumors have shown promise in the past.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Fudan Zhongshan Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yan Chen, PhD
- Email: yan12.chen@qilu-pharma.com
- Phone: 8617843558626
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.