A Study of Q-1802 in Patients With Advanced Solid Tumors

NCT ID: NCT04856150

Last Updated: 2023-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-21
• Study Completion Date: 2024-07-31

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 tolerance of Q-1802 in patients with advanced solid tumors, together with an assessment of pharmacokinetic characteristics and efficacy. The study consisted of two compartments: the dose-exploration stage and the dose-extension stage.

Conditions

Advanced Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Q-1802

Q-1802 dose exploration and Q-1802 dose extension

Group Type: EXPERIMENTAL

Q-1802

Intervention Type: DRUG

Q-1802 will be administered intravenously.

Interventions

Q-1802

Q-1802 will be administered intravenously.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

QureBio Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing cancer hospical

Beijing, , China

Site Status: RECRUITING

West China Second University Hospical, Sichuan University

Chengdu, , China

Site Status: RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status: RECRUITING

PKUCare Luzhong Hospital

Zibo, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xu Liang

Role: CONTACT

liangxu@qurebio.com

021-50920280

Facility Contacts

Lin Shen

Role: primary

Qin Yu

Role: primary

Jian Zhang

Role: primary

Jie Hou

Role: primary

Other Identifiers

Qure-1802-101

Identifier Type: -

Identifier Source: org_study_id