Status:
UNKNOWN
A Study of Q-1802 in Patients With Advanced Solid Tumors
Lead Sponsor:
QureBio Ltd.
Conditions:
Advanced Solid Tumors
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
Q-1802 is a bispecific antibody targeting both the tumor-specific antigen Claudin 18.2 and the immune checkpoint PD-L1. This is a multi-center, single-arm, open-label design to evaluate the safety and...
Eligibility Criteria
Inclusion
- Male or female, age ≥18 years and ≤75 years.
- Patients with at least one measurable lesion per RECIST (v1.1) (applicable to the dose-extension stage).
- Eastern Cooperative Oncology Group (ECOG) performance status score 0 or 1 at screening and no deterioration occurs within two weeks before enrollment.
- Life expectancy period ≥ 12 weeks.
- Patients who have sufficient baseline organ function and whose laboratory data meet the following criteria (receiving no treatment of blood transfusions, albumin, recombinant human thrombopoietin, or colony-stimulating factor within 14 days before the first dose of this study).
- Patients with advanced gastric mucinous adenocarcinoma, advanced ovarian mucinous carcinoma or other dominant tumors participating in the dose-extension stage must provide eligible tumor tissue samples for biomarker detection; if subjects agree, tumor tissue samples should also be provided during the dose-exploration stage.
Exclusion
- Patients who have received any prior PD-1/PD-L1 antibody therapy (applicable to the dose-exploration stage).
- Patients with uncontrolled blood pressure (systolic blood pressure ≥ 150 mm Hg and/or diastolic blood pressure ≥ 100 mm Hg) or previous hypertensive crisis or hypertensive encephalopathy.
- Patients with active peptic ulcer, gastric outlet obstruction or persistent recurrent vomiting.
- Patients with a history of monoclonal antibody allergic reaction.
- Patients who are considered ineligible by the investigator due to any other severe, acute or chronic disease or other causes that the investigator considers could affect the patient's participation or assessment in the study.
Key Trial Info
Start Date :
May 21 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT04856150
Start Date
May 21 2021
End Date
July 1 2024
Last Update
July 27 2023
Active Locations (4)
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1
Beijing cancer hospical
Beijing, China
2
West China Second University Hospical, Sichuan University
Chengdu, China
3
Fudan University Shanghai Cancer Center
Shanghai, China
4
PKUCare Luzhong Hospital
Zibo, China