Advanced Solid TumorsPhase 1NCT04856150
A Study of Q-1802 in Patients With Advanced Solid Tumors
A Phase 1 study testing Q-1802 in people with Advanced Solid Tumors, run by QureBio Ltd. at 4 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- Q-1802
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 4 sitesChina
- Study dates
- 21 May 2021to Jul 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Beijing cancer hospical
Beijing
Lin Shen
- Recruiting
West China Second University Hospical, Sichuan University
Chengdu
Qin Yu
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai
Jian Zhang
- Recruiting
PKUCare Luzhong Hospital
Zibo
Jie Hou
About this study
Official title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Q-1802 in Patients With Advanced Solid Tumors
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
- Being tested
- Q-1802
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q-1802Drug
Q-1802 will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| Q-1802 | Experimental | Q-1802 dose exploration and Q-1802 dose extension Receives: Drug: Q-1802 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days
Secondary outcomes (9)
Plasma concentration (Cmax)
Highest observed plasma concentration of Q-1802
Measured: 70 days
Time to achieve Cmax (Tmax)
Time of highest observed plasma concentration of Q-1802
Measured: 70 days
Area under the plasma concentration-time curve (AUC)
Area under the plasma concentration time curve of Q-1802
Measured: 70 days
PD-L1 receptor occupancy rate (RO)
PD-L1 receptor occupancy rate (RO) on the surface of T lymphocytes in peripheral blood at different time points of Q-1802
Measured: 70 days
Number of participants with treatment-related adverse events(TRAE)
TRAE is defined as the AEs that the casual relationship of the AE is ralated to Q-1802.
Measured: 70 days
Objective response rate (ORR)
ORR is defined as proportion of participants with complete response, partial response (CR+PR).
Measured: 70 days
Progression-free survival (PFS)
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.
Measured: 70 days
Duration of response ( DCR )
DCR is defined as proportion of participants with complete response, partial response, stable disease (CR+PR+SD).
Measured: 70 days
Duration of response ( DOR )
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
Measured: 70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start21 May 2021
- Primary completionApr 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- QureBio Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04856150
- Sponsor's protocol ID
- Qure-1802-101
- Status last verified
- Jul 2023
- First submitted
- 19 Apr 2021
- Last updated
- 27 Jul 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Clinical Trial to Evaluate the Safety, Tolerability and Efficacy of Q-1802 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04856150
- Acronym / sponsor ID
- Qure-1802-101
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- QureBio Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 May 2021 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 23 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Q-1802 | Experimental | Drug: Q-1802Q-1802 dose exploration and Q-1802 dose extension |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Q-1802Q-1802 will be administered intravenously. | Drug | Q-1802 |
Primary outcome
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.
9 secondary outcomes
Plasma concentration (Cmax)
Time frame: 70 days
Time to achieve Cmax (Tmax)
Time frame: 70 days
Area under the plasma concentration-time curve (AUC)
Time frame: 70 days
PD-L1 receptor occupancy rate (RO)
Time frame: 70 days
Number of participants with treatment-related adverse events(TRAE)
Time frame: 70 days
Objective response rate (ORR)
Time frame: 70 days
Progression-free survival (PFS)
Time frame: 70 days
Duration of response ( DCR )
Time frame: 70 days
Duration of response ( DOR )
Time frame: 70 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Q-1802 in people with Advanced Solid Tumors, run by QureBio Ltd. at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xu Liang (021-50920280, liangxu@qurebio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with dose limiting toxicities (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.