Testing Q-1802 for advanced solid tumors

A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Q-1802 in Patients With Advanced Solid Tumors

This study is testing a new treatment called Q-1802 to see if it can help people with advanced solid tumors by targeting specific proteins in their cancer cells.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: QureBio Ltd. (Industry-sponsored)
• Locations: 4 sites (Beijing and 3 other locations)
• Trial ID: NCT04856150 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates Q-1802, a bispecific antibody designed to target Claudin 18.2 and PD-L1 in patients with advanced solid tumors. It employs a multi-center, single-arm, open-label design to assess the safety, tolerance, pharmacokinetics, and efficacy of the treatment. The study is divided into two stages: a dose-exploration phase and a dose-extension phase, focusing on patients with measurable lesions. Participants will be monitored for their response to the treatment and any potential side effects.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 to 75 with advanced solid tumors and measurable lesions.

Not a fit: Patients with conditions that do not meet the eligibility criteria or those with a life expectancy of less than 12 weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors.

How similar studies have performed: Other studies involving bispecific antibodies targeting similar pathways have shown promise, suggesting potential for success in this approach.

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.

Where this trial is running

Beijing and 3 other locations

• Beijing cancer hospical — Beijing, China (Recruiting)
• West China Second University Hospical, Sichuan University — Chengdu, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)
• PKUCare Luzhong Hospital — Zibo, China (Recruiting)

Study contacts

• Study coordinator: Xu Liang

Conditions Advanced Solid Tumors