NCT04856150

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2021

Typical duration for phase_1

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 23, 2021

Completed
28 days until next milestone

Study Start

First participant enrolled

May 21, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

July 27, 2023

Status Verified

July 1, 2023

Enrollment Period

2.9 years

First QC Date

April 19, 2021

Last Update Submit

July 24, 2023

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

  • Number of participants with dose limiting toxicities

    Incidence of dose limiting toxicities(DLTs). A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first treatment cycle with Q-1802.

    28 days

Secondary Outcomes (9)

  • Plasma concentration (Cmax)

    70 days

  • Time to achieve Cmax (Tmax)

    70 days

  • Area under the plasma concentration-time curve (AUC)

    70 days

  • PD-L1 receptor occupancy rate (RO)

    70 days

  • Number of participants with treatment-related adverse events(TRAE)

    70 days

  • +4 more secondary outcomes

Study Arms (1)

Q-1802

EXPERIMENTAL

Q-1802 dose exploration and Q-1802 dose extension

Drug: Q-1802

Interventions

Q-1802DRUG

Q-1802 will be administered intravenously.

Q-1802

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

Central Study Contacts

Xu Liang

CONTACT

021-50920280liangxu@qurebio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 19, 2021

First Posted

April 23, 2021

Study Start

May 21, 2021

Primary Completion

April 1, 2024

Study Completion

July 1, 2024

Last Updated

July 27, 2023

Record last verified: 2023-07

Locations

CN(4)