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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04856150
Recruitment Status : Not yet recruiting
First Posted : April 23, 2021
Last Update Posted : April 23, 2021
Sponsor:
Information provided by (Responsible Party):
QureBio Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Drug: Q-1802 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Q-1802 in Patients With Advanced Solid Tumors
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : January 2023
Arms and Interventions
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Arm Intervention/treatment
Experimental: Q-1802
Q-1802 dose exploration and Q-1802 dose extension
 Drug: Q-1802
Q-1802 will be administered intravenously.


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with dose limiting toxicities [ Time Frame: 28 days ]
    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.


Secondary Outcome Measures :
  1. Plasma concentration (Cmax) [ Time Frame: 70 days ]
    Highest observed plasma concentration of Q-1802

  2. Time to achieve Cmax (Tmax) [ Time Frame: 70 days ]
    Time of highest observed plasma concentration of Q-1802

  3. Area under the plasma concentration-time curve (AUC) [ Time Frame: 70 days ]
    Area under the plasma concentration time curve of Q-1802

  4. PD-L1 receptor occupancy rate (RO) [ Time Frame: 70 days ]
    PD-L1 receptor occupancy rate (RO) on the surface of T lymphocytes in peripheral blood at different time points of Q-1802

  5. Number of participants with treatment-related adverse events(TRAE) [ Time Frame: 70 days ]
    TRAE is defined as the AEs that the casual relationship of the AE is ralated to Q-1802.

  6. Objective response rate (ORR) [ Time Frame: 70 days ]
    ORR is defined as proportion of participants with complete response, partial response (CR+PR).

  7. Progression-free survival (PFS) [ Time Frame: 70 days ]
    PFS is defined as the interval of time between the date of first treatment to the earliest date of disease progression or death which occurs first.

  8. Duration of response ( DCR ) [ Time Frame: 70 days ]
    DCR is defined as proportion of participants with complete response, partial response, stable disease (CR+PR+SD).

  9. Duration of response ( DOR ) [ Time Frame: 70 days ]
    DOR is defined as the time from the participant's initial objective response (CR or PR) to study drug therapy, to disease progression or death due to any cause, whichever occurs first


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04856150


Contacts
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Contact: Xu Liang 021-50920280 liangxu@qurebio.com

Locations
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China
Beijing cancer hospical
Beijing, China
Contact: Lin Shen         
West China Second University Hospical, Sichuan University
Chengdu, China
Contact: Qin Yu         
Fudan University Shanghai Cancer Center
Shanghai, China
Contact: Jian Zhang         
PKUCare Luzhong Hospital
Zibo, China
Contact: Jie Hou         
Sponsors and Collaborators
QureBio Ltd.
More Information
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Responsible Party: QureBio Ltd.
ClinicalTrials.gov Identifier: NCT04856150    
Other Study ID Numbers: Qure-1802-101
First Posted: April 23, 2021    Key Record Dates
Last Update Posted: April 23, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms