A Study of QLC5508 Combinations in Patients With Advanced Solid Tumors
A Phase Ib/II, Open-label, Multi-center Study to Evaluate Safety, Tolerability, Pharmacokinetics and Efficacy of Intravenous Administration of QLC5508 in Combination With Other Anti-tumor Agents in Patients With Advanced Solid Tumors
Qilu Pharmaceutical Co., Ltd.
444 participants
Oct 24, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria10
- At least 18 years of age at screening;
- Histologically or cytologically confirmed advanced solid tumors:
- Dose escalation part will enroll participants who have progressed on or are intolerant to available standard therapies.
- Dose expansion part will enroll participants who have not received prior treatment for advanced/metastatic diseases.
- At least one measurable target lesion according to RECIST v1.1
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0~1
- Life expectancy ≥12 weeks
- Female or male participants should be willing to use appropriate contraceptive measures throughout the study;
- Female participants should have a negative blood pregnancy test within 7 days prior to the first dose or have evidence of non-childbearing potential;
- A signed written Informed Consent Form
Exclusion Criteria18
- Received or undergoing any of the following treatment:
- Previous or current treatment with B7-H3 targeted therapy
- Previous or current treatment with topoisomerase I inhibitors
- Previous treatment with cytotoxic chemotherapy, investigational agents, traditional Chinese medicine with an anti-tumor indication and antitumor drugs within 14 days prior to the first dose
- Previous treatment with macromolecular antitumor drugs within 28 days prior to the first dose
- f. Radiotherapy with a limited field of radiation within 2 weeks prior to the first dose; or more than 30% of the bone marrow irradiation, or large-scale radiotherapy within 4 weeks prior to the first dose e. Pleural effusion or ascites requiring clinical intervention; or presence of pericardial effusion f. Major surgery within 4 weeks prior to the first dose g. Brain metastases; leptomeningeal or brainstem metastases; or spinal cord compression
- Unresolved AEs ≥ Grade 2 (CTCAE v5.0) from prior therapy except for alopecia and residual neuropathy
- Previous or concurrent primary malignancies
- Inadequate bone marrow reserve or organ dysfunction
- Evidence of cardiovascular risk
- Evidence of current severe or uncontrolled systemic diseases
- Severe infection within 4 weeks prior to the first dose; or uncontrolled active infection at screening
- Known or suspected interstitial lung disease; or other moderate to severe pulmonary diseases that significantly impair respiratory function and may interfere with the detection or management of drug-related pulmonary toxicity
- High risk of gastrointestinal or abdominal bleeding 10. Gastrointestinal diseases of clinical significance within 3 months prior to the first dose
- History of severe neuropathy or mental disorders
- History of severe hypersensitivity reaction, severe infusion reaction or idiosyncrasy to drugs chemically related to QLC5508 or any of the components of QLC5508
- Unlikely to comply with study procedures and requirements in the opinion of the investigator
- Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments
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Interventions
2.4 mg/kg and 2.0 mg/kg, Q3W/Q2W,administered as an IV infusion
5 mg/kg ,Q3W,administered as an IV infusion
Cisplatin(75 mg/m2; Q3W) / Carboplatin（AUC 5 mg/mL/min; Q3W）,administered as an IV infusion
200 mg, Q3W,administered as an IV infusion
175 mg/m2, Q3W,administered as an IV infusion
800 mg/m2,Q3W(arm:QLC5508, QL2107 and 5-FU),administered as an IV infusion;1200 mg/m2, Q2W(arm:QLC5508, Oxaliplatin, 5-FU,and leucovorin),administered as an IV infusion
30 mg/m2, Q2W,administered as an IV infusion
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07256782