Gastroesophageal Junction (GEJ) AdenocarcinomaPhase 1/2NCT05964543
The Safety and Efficacy of Q-1802 Combined With XELOX in Gastrointestinal Tumors
A Phase 1/2 study testing Q-1802 Injection,Oxaliplatin Injection,Capecitabine in people with Gastroesophageal Junction (GEJ) Adenocarcinoma, run by QureBio Ltd. at 1 site in China.
Trial summary
The main purpose of this study is to evaluate safety, tolerability and the efficacy of Q-1802 plus SOC compared with SOC. .Pharmacokinetics (PK) ,Pharmacodynamics (PD) of Q-1802 and the immunogenicity profile of Q-1802 will be evaluated as well. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastroesophageal Junction (GEJ) Adenocarcinoma
- What is being tested?
- Q-1802 Injection,Oxaliplatin Injection,Capecitabine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2023to 30 Aug 2025
- Phase
- Phase 1/2
- 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
- Patients with at least one measurable lesion per RECIST (v1.1);
- Patients with medium or high expression of Claudin18.2 in tumor tissue samples tested by immunohistochemistry in central laboratory were included;
- Patients with untreated, unresectable advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma with negative HER-2 immunohistochemistry or FISH test (HER-2 immunohistochemistry 0/1+ confirmed by a qualified local or central laboratory, or 2+ confirmed negative by FISH test) were included;
- 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.
Who cannot join
- Receive anti-tumor treatment within 4 weeks before the first administration or within 5 half-lives of the treatment drug, whichever is shorter;
- Patients who have previously used Claudin 18.2 products for treatment;
- With uncontrolled diseases;
- Who are allergic to the study drug or any of its components;
- Patients with a history of other primary malignant tumors at the time of screening, except for cured skin Basal-cell carcinoma or Cutaneous squamous-cell carcinoma or cervical Carcinoma in situ.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing cancer hospical
Beijing, Beijing Municipality, 100142
Lin Shen, MD, 86-13911219511, shenlin@bjmu.edu.cn
About this study
Official title: A Phase I/II Clinical Trial to Evaluate the Safety Tolerance and Initial Efficacy of Q-1802 Combined With Standard Treatment in Patients With Gastrointestinal Tumors
The main purpose of this study is to evaluate safety, tolerability and the efficacy of Q-1802 plus SOC compared with SOC. .Pharmacokinetics (PK) ,Pharmacodynamics (PD) of Q-1802 and the immunogenicity profile of Q-1802 will be evaluated as well.
Read the detailed description
This study is a multicenter, open label, phase Ⅰb/Ⅱ clinical study conducted in unresectable patients with advanced or recurrent metastatic Claudin18.2 positive (medium and high expression) and HER-2 negative primary gastric adenocarcinoma or gastric esophageal junction adenocarcinoma. The Phase Ib dose escalation study included two dose groups each combined with the XELOX standard treatment regimen. Perform dose escalation to obtain MTD and/or RP2D doses for combined administration. The Phase II study adopted an open label parallel randomized controlled design. Further observe the efficacy and safety of Q-1802 combined with XELOX regimen in treating patients with moderate to high expression of Claudin 18.2, and compare and analyze the efficacy and safety of Q-1802 combined with XELOX regimen and XELOX regimen alone.
- Being tested
- Q-1802 Injection,Oxaliplatin Injection,Capecitabine
- Keywords
- Neoplasms
- Medical subject headings
- Adenocarcinoma, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q-1802 Injection,Oxaliplatin Injection,CapecitabineDrug
Also called Q-1802,Oxaliplatin Injection,Xeloda
Q-1802：A dose Q-1802 will be administered intravenously Q2W. XELOX（oxaliplatin，capecitabin）: 21 days as a cycle Oxaliplatin will be administered 130mg/m2 as a 2-hour IV infusion,administer once on the first day, with 21 days as a cycle Capecitabine will be administered 1000mg/m2 orally twice daily (D1-D14),21ds is one cycle.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ib: Dose escalation Q-1802+XELOX, | Experimental | According to "3+3" design, a dose of Q-1802 with two dose groups from low to high and one cycle fixed-dose XELOX will be given in DLT observation period. After DLT observation period, Q-1802+XELOX will be given by investigator,s decision until the subject meets study treatment discontinuation criteria. Receives: Drug: Q-1802 Injection,Oxaliplatin Injection,Capecitabine |
| Phase II: Q-1802 + XELOX Vs XELOX ; | Placebo comparator | Phase II:Participants will be randomized to group A and B. Group A:receive a dose of Q-1802 at Cycle 1 Day 1 followed by a same dose in subsequent cycles every 2 weeks. Additionally, participants will receive XELOX (capecitabine/oxaliplatin) treatment until investigator confirmed disease progression or a total of 8 treatments (each cycle is defined as approximately 21 days). Oxaliplatin is administered on day 1 of each cycle, whereas capecitabine is taken twice daily on days 1 through 14. After a maximum of 8 treatments of Oxaplatin, subjects may continue to receive Q-1802 a every 2 weeks each cycle and capecitabine every 3 weeks at the investigator's discretion until the subject meets study treatment discontinuation criteria. Group B:Participants will receive XELOX (capecitabine/oxaliplatin) treatment alone until a total of 8 treatments (each cycle is defined as approximately 21 days). subjects may continue to receive capecitabine every 3 weeks at the investigator's discretion. Receives: Drug: Q-1802 Injection,Oxaliplatin Injection,Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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: From the first dose of study drug administration up to 30 days after the last study medication administration, up to 12months
Objective response rate (ORR)
ORR is defined as proportion of participants with complete response, partial response (CR+PR).
Measured: From the first dose of study drug administration up to 6 months after the last pts in,up to19 months
Secondary outcomes (1)
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: From the first dose of study drug administration up to the last pts who disease progression or death which occurs first,up to 21months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start21 Jun 2023
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Junction (GEJ) AdenocarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase Ib: Dose escalation;Phase II:Arm A：Combined administration group Q-1802 plus XELOX,Arm B Standard treatment group: XELOX alone
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- QureBio Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Shen, MD, Principal investigator, Department of Medical Oncology, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964543
- Sponsor's protocol ID
- Q-1802-201
- Status last verified
- Jul 2023
- First submitted
- 19 Jul 2023
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Trial to Evaluate the Safety Tolerance and Initial Efficacy of Q-1802 Combined With Standard Treatment in Patients With Gastrointestinal Tumors
- ClinicalTrials.gov ID
- NCT05964543
- Acronym / sponsor ID
- Q-1802-201
- Keywords
- Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- QureBio Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2023 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 28 Jul 2023 (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.
The main purpose of this study is to evaluate safety, tolerability and the efficacy of Q-1802 plus SOC compared with SOC. .Pharmacokinetics (PK) ,Pharmacodynamics (PD) of Q-1802 and the immunogenicity profile of Q-1802 will be evaluated as well.
Detailed description
This study is a multicenter, open label, phase Ⅰb/Ⅱ clinical study conducted in unresectable patients with advanced or recurrent metastatic Claudin18.2 positive (medium and high expression) and HER-2 negative primary gastric adenocarcinoma or gastric esophageal junction adenocarcinoma. The Phase Ib dose escalation study included two dose groups each combined with the XELOX standard treatment regimen. Perform dose escalation to obtain MTD and/or RP2D doses for combined administration. The Phase II study adopted an open label parallel randomized controlled design. Further observe the efficacy and safety of Q-1802 combined with XELOX regimen in treating patients with moderate to high expression of Claudin 18.2, and compare and analyze the efficacy and safety of Q-1802 combined with XELOX regimen and XELOX regimen alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase Ib: Dose escalation;Phase II:Arm A：Combined administration group Q-1802 plus XELOX,Arm B Standard treatment group: XELOX alone
| Arm | Type | Receives |
|---|---|---|
| Phase Ib: Dose escalation Q-1802+XELOX, | Experimental | Drug: Q-1802 Injection,Oxaliplatin Injection,CapecitabineAccording to "3+3" design, a dose of Q-1802 with two dose groups from low to high and one cycle fixed-dose XELOX will be given in DLT observation period. After DLT observation period, Q-1802+XELOX will be given by investigator,s decision until the subject meets study treatment discontinuation criteria. |
| Phase II: Q-1802 + XELOX Vs XELOX ; | Placebo comparator | Drug: Q-1802 Injection,Oxaliplatin Injection,CapecitabinePhase II:Participants will be randomized to group A and B. Group A:receive a dose of Q-1802 at Cycle 1 Day 1 followed by a same dose in subsequent cycles every 2 weeks. Additionally, participants will receive XELOX (capecitabine/oxaliplatin) treatment until investigator confirmed disease progression or a total of 8 treatments (each cycle is defined as approximately 21 days). Oxaliplatin is administered on day 1 of each cycle, whereas capecitabine is taken twice daily on days 1 through 14. After a maximum of 8 treatments of Oxaplatin, subjects may continue to receive Q-1802 a every 2 weeks each cycle and capecitabine every 3 weeks at the investigator's discretion until the subject meets study treatment discontinuation criteria. Group B:Participants will receive XELOX (capecitabine/oxaliplatin) treatment alone until a total of 8 treatments (each cycle is defined as approximately 21 days). subjects may continue to receive capecitabine every 3 weeks at the investigator's discretion. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with at least one measurable lesion per RECIST (v1.1);
- Patients with medium or high expression of Claudin18.2 in tumor tissue samples tested by immunohistochemistry in central laboratory were included;
- Patients with untreated, unresectable advanced or metastatic gastric adenocarcinoma or gastroesophageal junction adenocarcinoma with negative HER-2 immunohistochemistry or FISH test (HER-2 immunohistochemistry 0/1+ confirmed by a qualified local or central laboratory, or 2+ confirmed negative by FISH test) were included;
- 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;
Key exclusion criteria (5 listed)
- Receive anti-tumor treatment within 4 weeks before the first administration or within 5 half-lives of the treatment drug, whichever is shorter;
- Patients who have previously used Claudin 18.2 products for treatment;
- With uncontrolled diseases;
- Who are allergic to the study drug or any of its components;
- Patients with a history of other primary malignant tumors at the time of screening, except for cured skin Basal-cell carcinoma or Cutaneous squamous-cell carcinoma or cervical Carcinoma in situ.
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-1802 Injection,Oxaliplatin Injection,CapecitabineAlso: Q-1802,Oxaliplatin Injection,XelodaQ-1802：A dose Q-1802 will be administered intravenously Q2W. XELOX（oxaliplatin，capecitabin）: 21 days as a cycle Oxaliplatin will be administered 130mg/m2 as a 2-hour IV infusion,administer once on the first day, with 21 days as a cycle Capecitabine will be administered 1000mg/m2 orally twice daily (D1-D14),21ds is one cycle. | Drug | Phase II: Q-1802 + XELOX Vs XELOX ;, Phase Ib: Dose escalation Q-1802+XELOX, |
Primary outcome
Number of participants with treatment-related adverse events(TRAE)
Time frame: From the first dose of study drug administration up to 30 days after the last study medication administration, up to 12months
TRAE is defined as the AEs that the casual relationship of the AE is ralated to Q-1802
Objective response rate (ORR)
Time frame: From the first dose of study drug administration up to 6 months after the last pts in,up to19 months
ORR is defined as proportion of participants with complete response, partial response (CR+PR).
1 secondary outcome
Progression-free survival (PFS)
Time frame: From the first dose of study drug administration up to the last pts who disease progression or death which occurs first,up to 21months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Individual participant dataSharing planned: No
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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.
Lin Shen, MD principal investigator
Department of Medical Oncology, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Q-1802 Injection,Oxaliplatin Injection,Capecitabine in people with Gastroesophageal Junction (GEJ) Adenocarcinoma, run by QureBio Ltd. at 1 site 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 28 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 1 site 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 LI WEI, MD (86-021-50920280, weili@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 treatment-related adverse events(TRAE) (time frame: From the first dose of study drug administration up to 30 days after the last study medication administration, up to 12months). The study lists 2 primary outcomes in all. 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 28 Jul 2023.