NCT07467629 QLS5212 for Participants With Advanced Solid Tumors
| NCT ID | NCT07467629 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Condition | Solid Tumor Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-05-11 |
| Primary Completion | 2027-11-05 |
Eligibility & Interventions
Eligibility Fast-Check
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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 100 participants in total. It began in 2026-05-11 with a primary completion date of 2027-11-05.
⚠ 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
This is a Phase 1, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of intravenously administered QLS5212 in participants with unresectable locally, advanced or metastatic cancer.
Eligibility Criteria
Inclusion Criteria: * Being able to provide informed consent and documentation of informed consent prior to initiation of any study-related tests or procedures that are not part of standard-of-care for the patient's disease. * Patients must also be willing and able to comply with study procedures, including the acquisition of specified research specimens. * Age ≥ 18 years old. * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * For Dose Escalation, patients with histologically diagnosed unresectable, locally advanced, or metastatic solid tumors. * Life expectancy ≥ 3 months. * Measurable disease as per Response Evaluation Criteria in Solid Tumors version 1.1 criteria and documented by CT and/or MRI. 7\. Acceptable laboratory parameters: 1. Absolute neutrophil count ≥ 1,500/μL. 2. Platelet count ≥ 100 × 1000/μL 3. Hemoglobin ≥ 9.0 g/dL. 4. Albumin ≥ 3 g/dL. 5. ALT/AST ≤ 3.0 × ULN.（for patients with hepatic metastases, ALT and AST ≤ 5 × ULN.） 6. Total bilirubin ≤ 1.5 ULN or ≤ 3 x ULN for patients with Gilbert's disease. 7. a calculated or measured creatinine clearance ≥60 mL/minute. * Identification of an archival tumor sample (i.e., tissue block \[formalin-fixed paraffin-embedded\] or a series of approximately 10-15 slides). Exclusion Criteria: * History of other primary malignancies, except: Basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, or papillary thyroid cancer that has been definitively treated with no evidence of recurrence; Other malignancies that have been adequately treated and remain disease-free for ≥3 years prior to first study dose; * Untreated or active brain metastases, including leptomeningeal carcinomatosis; * Prior systemic anti-cancer therapy within specified windows; * Prior treatment with Monomethyl auristatin E (MMAE)- or Monomethylauristatin F (MMAF)-based antibody-drug conjugates (e.g., enfortumab vedotin, disitamab vedotin, tisotumab vedotin) or any TPBG-targeted therapy; * Clinically significant cardiovascular disease; * Uncontrolled systemic infection or active tuberculosis; * Active autoimmune disease requiring systemic immunosuppressive therapy within the past 2 years; * Active interstitial lung disease (ILD) or suspected ILD that cannot be ruled out by imaging at screening.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07467629 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor Cancer. 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 NCT07467629 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 NCT07467629 currently recruiting?
Yes, NCT07467629 is actively recruiting participants. Contact the research team at zlhuxi@163.com for enrollment information.
Where is the NCT07467629 trial being conducted?
This trial is being conducted at Taiyuan, China.
Who is sponsoring the NCT07467629 clinical trial?
NCT07467629 is sponsored by Qilu Pharmaceutical Co., Ltd.. The trial plans to enroll 100 participants.
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