Actively Recruiting
A Study of QLC5508 Combinations in Patients With Advanced Solid Tumors
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2025-12-01
444
Participants Needed
1
Research Sites
131 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
QLC5508 is a fully humanized IgG1 antibody-drug conjugate (ADC) which specifically binds to B7-H3, a target wildly expressed on solid tumor cells. The objectives of this study are to investigate the safety, tolerability, pharmacokinetics and anti-tumor activity of QLC5508 in combination with other anti-cancer agents in patients with advanced solid tumor patients.
CONDITIONS
Official Title
A Study of QLC5508 Combinations in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age at screening
- Histologically or cytologically confirmed advanced solid tumors
- For dose escalation: progressed on or intolerant to standard therapies
- For dose expansion: no prior treatment for advanced/metastatic disease
- At least one measurable target lesion per RECIST v1.1
- ECOG Performance Status of 0 or 1
- Life expectancy of at least 12 weeks
- Willingness to use appropriate contraceptive measures during the study
- Female participants must have a negative pregnancy test within 7 days before first dose or be non-childbearing
- Signed informed consent form
You will not qualify if you...
- Previous or current treatment with B7-H3 targeted therapy
- Previous or current treatment with topoisomerase I inhibitors
- Treatment with cytotoxic chemotherapy, investigational agents, traditional Chinese medicine with anti-tumor indication, or antitumor drugs within 14 days before first dose
- Treatment with macromolecular antitumor drugs within 28 days before first dose
- Radiotherapy with limited field within 2 weeks before first dose, or more than 30% bone marrow irradiation or large-scale radiotherapy within 4 weeks before first dose
- Pleural effusion or ascites needing clinical intervention, or pericardial effusion
- Major surgery within 4 weeks before first dose
- Brain metastases, leptomeningeal or brainstem metastases, or spinal cord compression
- Unresolved adverse events grade 2 or higher from prior therapy except alopecia and residual neuropathy
- Previous or concurrent primary malignancies
- Inadequate bone marrow reserve or organ dysfunction
- Evidence of cardiovascular risk
- Severe or uncontrolled systemic diseases
- Severe infection within 4 weeks before first dose or uncontrolled active infection at screening
- Known or suspected interstitial lung disease or other moderate to severe pulmonary diseases affecting respiratory function
- High risk of gastrointestinal or abdominal bleeding
- Significant gastrointestinal diseases within 3 months before first dose
- History of severe neuropathy or mental disorders
- History of severe hypersensitivity or infusion reactions to QLC5508 or related drugs
- Unlikely to comply with study procedures or requirements
- Any condition compromising safety or study assessments per investigator opinion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanghai East Hospital
Shanghai, China
Actively Recruiting
Research Team
Q
Qianyun Liu, Master
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
6
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