Testing QLP2117 in patients with advanced solid tumors
A Study Evaluates the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLP2117 in Advanced Solid Tumor Patients
This study is testing a new treatment called QLP2117 to see if it can help people with advanced solid tumors who have run out of other options.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Qilu Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Guangzhou) |
| Trial ID | NCT05830045 on ClinicalTrials.gov |
What this trial studies
This is a Phase I clinical trial evaluating the safety, pharmacokinetics, immunogenicity, and efficacy of QLP2117 in patients diagnosed with advanced solid tumors. The study aims to enroll individuals who have either progressed on standard therapies or have no available treatment options. Participants will receive QLP2117 and will be monitored for their response to the treatment, as well as any potential side effects. The trial will include both dose escalation and expansion cohorts to assess the drug's effectiveness.
Who should consider this trial
Good fit: Ideal candidates are patients with recurrent or refractory advanced solid tumors who have progressed on standard therapy or have no available standard therapy.
Not a fit: Patients who are pregnant, breastfeeding, or have active autoimmune diseases 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 treatment alternatives.
How similar studies have performed: Other studies have shown promise with similar investigational therapies, but this specific approach with QLP2117 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy. 2. At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1(phase Ia dose escalation only requires at least one assessable lesion) 3. Eastern Cooperative Oncology Group Performance Status of 0 or 1 4. Agree to provide archived tumor tissue samples of primary or metastatic lesions. 5. Have adequate organ function as described in the protocol. Exclusion Criteria: 1. Women who are pregnant or breastfeeding 2. HBsAg/HBcAb positive and HBV-DNA\>1000 copy/mL;HCV-Ab positive and detection of HCV-RNA suggested viral replication 3. Is currently participating and receiving study medication in another study within 4 week prior to the first dose of study treatment 4. Has an active autoimmune disease that has required systemic treatment in past 2 years. 5. Has an active infection requiring systemic therapy 6. Has received a live vaccine wihtin 30 days of planned start of study treatment 7. Has know history of, or any evidence of interstitial lung disease
Where this trial is running
Guangzhou
- Sun Yat-sen University Cancer Center — Guangzhou, China (Recruiting)
Study contacts
- Principal investigator: Xu Ruihua, PhD — Sun Yat-sen University
- Study coordinator: Zhang Meijiang, PhD
- Email: meijiang.zhang@qilu-pharma.com
- Phone: 8615210162105
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.