Clinical trial NCT04856150: A Study of Q-1802 in Patients With Advanced Solid Tumors
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Q-1802 in Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors
Lead sponsor: QureBio Ltd.
Sponsor class: INDUSTRY
First posted: 2021-04-23
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of participants with dose limiting toxicities
timeFrame: 28 days
Secondary outcomes:
measure: Plasma concentration (Cmax)
timeFrame: 70 days
measure: Time to achieve Cmax (Tmax)
timeFrame: 70 days
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: 70 days
measure: PD-L1 receptor occupancy rate (RO)
timeFrame: 70 days
measure: Number of participants with treatment-related adverse events(TRAE)
timeFrame: 70 days
measure: Objective response rate (ORR)
timeFrame: 70 days
measure: Progression-free survival (PFS)
timeFrame: 70 days
measure: Duration of response ( DCR )
timeFrame: 70 days
measure: Duration of response ( DOR )
timeFrame: 70 days
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing cancer hospical
city: Chengdu
country: China
facility: West China Second University Hospical, Sichuan University
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Zibo
country: China
facility: PKUCare Luzhong Hospital
Study officials:
References: