NCT07256782 A Study of QLC5508 Combinations in Patients With Advanced Solid Tumors
| NCT ID | NCT07256782 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Condition | Advanced Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 444 participants |
| Start Date | 2025-10-24 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 444 participants in total. It began in 2025-10-24 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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 Criteria: * . Received or undergoing any of the following treatment: 1. Previous or current treatment with B7-H3 targeted therapy 2. Previous or current treatment with topoisomerase I inhibitors 3. 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 4. 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07256782 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07256782 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07256782 currently recruiting?
Yes, NCT07256782 is actively recruiting participants. Contact the research team at qianyun.liu@qilu-pharma.com for enrollment information.
Where is the NCT07256782 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07256782 clinical trial?
NCT07256782 is sponsored by Qilu Pharmaceutical Co., Ltd.. The trial plans to enroll 444 participants.