IBI363 + ChemotherapyPhase 1NCT06610799
Study of IBI363 in Patients with Advanced First-line Gastric Cancer
A Phase 1 study testing IBI363 in people with IBI363 + Chemotherapy, run by Xiangdong Cheng at 1 site in China.
Trial summary
This is a phase 1b study designed to evaluate the safety, tolerability and efficacy of IBI363 in combination with oxaliplatin and capecitabine (XELOX) in first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- IBI363 + Chemotherapy
- What is being tested?
- IBI363
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2024to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 subjects, ≥ 18 years and ≤75 years.
- Subjects with unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma without prior systematic treatment.
- Subjects with at least one measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Expected survival time ≥ 3 months.
Who cannot join
- Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug.
- Active uncontrolled bleeding or a known bleeding diathesis.
- Subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Xiangdong Cheng, 13968032995, chengxd516@126.com
About this study
Official title: Phase Ib Study to Evaluate the Safety, Tolerability and Efficacy of IBI363 in Combination with Oxaliplatin and Capecitabine (XELOX) in First-line Treatment of Unresectable Advanced or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma
This is a phase 1b study designed to evaluate the safety, tolerability and efficacy of IBI363 in combination with oxaliplatin and capecitabine (XELOX) in first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma.
- Conditions
- IBI363 + Chemotherapy
- Being tested
- IBI363
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI363Drug
IBI363 Q3W Oxaliplatin 130 mg/m2，IV，Q3W, Capecitabine ,1000mg/ m2，PO，Bid，d1-14，Q3W
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | IBI363 combination with oxaliplatin and capecitabine (XELOX) for first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma Receives: Drug: IBI363 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (ORR)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Measured: Through out the study (up to 2 years)
Disease control rate (DCR)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Measured: Through out the study (up to 2 years)
Secondary outcomes (3)
Progression Free Survival（PFS）;
The efficacy of solid tumors was evaluated according to RECIST v1.1
Measured: Up to 2 years
Overall Survival, OS）
The efficacy of solid tumors was evaluated according to RECIST v1.1
Measured: Up to 2 years
Adverse Enent (AE), Treatment-Emergent AE (TEAE), Adverse Event of Special Interest (AESI) and Serious Adverse Event (SAE)
Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0.
Measured: Up to 90 days after the last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start15 Oct 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBI363 + ChemotherapyStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiangdong Cheng
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiangdong Cheng, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06610799
- Sponsor's protocol ID
- CIBI363Y110
- Status last verified
- Sep 2024
- First submitted
- 18 Sep 2024
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ib Study to Evaluate the Safety, Tolerability and Efficacy of IBI363 in Combination with Oxaliplatin and Capecitabine (XELOX) in First-line Treatment of Unresectable Advanced or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma
- ClinicalTrials.gov ID
- NCT06610799
- Acronym / sponsor ID
- CIBI363Y110
- Conditions
- IBI363 + Chemotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xiangdong ChengUniversity, hospital or other
- Study start
- 15 Oct 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 24 Sep 2024 (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.
This is a phase 1b study designed to evaluate the safety, tolerability and efficacy of IBI363 in combination with oxaliplatin and capecitabine (XELOX) in first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: IBI363IBI363 combination with oxaliplatin and capecitabine (XELOX) for first-line treatment of unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female subjects, ≥ 18 years and ≤75 years.
- Subjects with unresectable advanced or metastatic gastric and gastroesophageal junction adenocarcinoma without prior systematic treatment.
- Subjects with at least one measurable lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.
- Expected survival time ≥ 3 months.
Key exclusion criteria (3 listed)
- Women who are pregnant or lactating, or intending to become pregnant before, during, or within 6 months after the last dose of study drug.
- Active uncontrolled bleeding or a known bleeding diathesis.
- Subjects with history of or known active seizure disorder, brain metastases, spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
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 |
|---|---|---|
| IBI363IBI363 Q3W Oxaliplatin 130 mg/m2，IV，Q3W, Capecitabine ,1000mg/ m2，PO，Bid，d1-14，Q3W | Drug | Cohort 1 |
Primary outcome
Objective response rate (ORR)
Time frame: Through out the study (up to 2 years)
The efficacy of solid tumors was evaluated according to RECIST v1.1
Disease control rate (DCR)
Time frame: Through out the study (up to 2 years)
The efficacy of solid tumors was evaluated according to RECIST v1.1
3 secondary outcomes
Progression Free Survival（PFS）;
Time frame: Up to 2 years
Overall Survival, OS）
Time frame: Up to 2 years
Adverse Enent (AE), Treatment-Emergent AE (TEAE), Adverse Event of Special Interest (AESI) and Serious Adverse Event (SAE)
Time frame: Up to 90 days after the last administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
- Individual participant dataSharing planned: Undecided
Related trials for IBI363 + Chemotherapy
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Resectable Stage IB-III Non-Squamous Non-Small Cell Lung Cancer
RecruitingPhase 2
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Unresectable Stage III Non-small Cell Lung Cancer, Carcinoma, Non-Small-Cell Lung Cancer (NSCLC)
Not yet recruitingPhase 1/2
Phase Ib/II Study to Evaluate the Safety and Efficacy of IBI363 in Combination With Chemotherapy as Second-Line Therapy for Unresectable Locally Advanced or Metastatic Pancreatic Cancer
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RecruitingPhase 2
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IBI363 + Chemotherapy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IBI363 in people with IBI363 + Chemotherapy, run by Xiangdong Cheng 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 20 Nov 2024. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanxi Pu (18523197816, yanxi.pu@innoventbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (ORR) (time frame: Through out the study (up to 2 years)). 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 20 Nov 2024.