Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| QLS5212 Dose Escalation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| QLS5212 | Drug | An anti-trophoblast glycoprotein antibody-drug conjugate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum tolerated dose (MTD) | From First Patient Dosed to end of Escalation (up to 14 months). | |
| Dose-limiting Toxicity (DLT) | From enrollment to 21 days of treatment. | |
| Recommended Phase 2 dose (RP2D) | From First Patient Dosed to end of Escalation (up to 14 months). | |
| Incidence of Treatment-Emergent Adverse Events | From enrollment of the first participant to 30 days after last dose of treatment or End of Treatment [EOT] visit (whichever is later). |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration of QLS5212 | From Day 1 of dosing through 7 days after last dose. | |
| Area Under the Curve (AUC) of QLS5212 | From Day 1 of dosing to 7 days after last dose. | |
Not provided
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:
Identification of an archival tumor sample (i.e., tissue block [formalin-fixed paraffin-embedded] or a series of approximately 10-15 slides).
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jie Wang, Doctor | Contact | 0351-4881611 | zlhuxi@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanxi Provincial Cancer Hospital (China Medical Sciences Academy Cancer Hospital Shanxi Hospital) | Recruiting | Taiyuan | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Circulating anti-drug antibodies (ADA) of QLS5212 |
| From Day 1 of dosing to 7 days after last dose. |