Advanced Solid TumorPhase 1NCT05043298
A Phase Ia/Ib Clinical Trial of IBI360 Monotherapy or in Combination With Sintilimab and (or) Chemotherapy in Advanced or Metastatic Solid Tumors
A Phase 1 study testing IBI 360 Injection and IBI 360 Injection Sintilimab in people with Advanced Solid Tumor, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is an open label Phase Ia/Ib trial to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of IBI360 monotherapy in Advanced or Metastatic Solid Tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- IBI 360 Injection and IBI 360 Injection Sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 27 Oct 2021to 30 Aug 2023
- 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
- Provide signed informed consent;
- Male or female aged at 18-75 (inclusive) years;
- Expected survival ≥12 weeks;
- ECOG PS score 0 or 1;
- Provide archival or fresh tissues for CLDN18.2 expression analysis;
- Adequate laboratory parameters;
Show all 9Show fewer
- Suffer from advanced or metastatic malignant local solid tumors confirmed by histological diagnosis and meet the criteria of the enrolled group as follows:
- Ia: The subjects for whom no standard treatment regimens are available or who is intolerable to standard treatments.
- Ib: pancreatic carcinoma, HER2 negative gastric adenocarcinoma, advanced or metastatic solid tumors
Who cannot join
- The subjects who received the treatment with CLDN18.2 monoclonal antibody or CLDN-18.2 CART;
- The subjects who received other anti-tumor medication within 4 weeks prior to the initial dose of the study drug;
- Any toxicity due to previous anti-tumor therapy that has not yet resolved to NCI CTCAE v5.0 grade 0 or 1 prior to the first dose of study treatment;
- The subjects with history of hypersensitivity to the study drug;
- The subjects were not recovery after surgery with history of gastrointestinal perforation or fistula within 6 months prior to the enrollment;
- The subjects with symptomatic central nervous system (CNS) metastasis or carcinomatous meningitis;
- The subjects with pyloric obstruction;
- The subjects with active or poorly controlled serious infections
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ia/Ib Open-Label, Multi-Center Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI360 Monotherapy or in Combination With Sintilimab and (or) Chemotherapy in Advanced or Metastatic Solid Tumors
This is an open label Phase Ia/Ib trial to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of IBI360 monotherapy in Advanced or Metastatic Solid Tumors
Read the detailed description
Phase Ia is dose escalation and dose expansion study of IBI360 monotherapy and IBI360 in combination with sintilimab in advanced or metastatic Solid Tumors; Phase Ib is an multi-cohort trial of pancreatic carcinoma, HER2 negative gastric adenocarcinoma, advanced or metastatic solid tumors to evaluate safety and preliminary efSficacy of IBI360 in combination with sintilimab and (or) chemotherapy or IBI360 monotherapy.
- Conditions
- Advanced Solid Tumor
- Being tested
- IBI 360 Injection, IBI 360 Injection Sintilimab
- Keywords
- Advanced Solid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI 360 InjectionDrug
IBI 360 dose level of escalation IV Q3W Day 1
IBI 360 Injection SintilimabDrug
IBI 360 dose level of escalation IV Q3W Day 1 Sintilimab 200mg IV Q3W Day 1
| Study group | Role | What they receive |
|---|---|---|
| IBI360 | Experimental | Not described Receives: Drug: IBI 360 Injection |
| IBI 360 + Sintilimab | Experimental | Not described Receives: Drug: IBI 360 Injection Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerance
Participant safety is characterized by frequency and severity of adverse events(according to NCI CTCAE 5.0)
Measured: up to 90 days following last dose
Recommended Phase 2 Dose (RP2D)
A recommended phase 2 dose will be determined based on safety data including dose limiting toxicities, preliminary efficacy data, and PK data
Measured: up to 21 days following last dose level
Secondary outcomes (7)
Efficacy
Tumor response will be determined by the revised Response Evaluation Criteria in Solid Tumors version 1.1 (RECISTv1.1).
Measured: Subjects were randomized 6 months and 1 year later
Pharmacokinetics
Area under plasma concentration vs time curve(AUC)
Measured: Up to 48 weeks following first dose
Immunogenicity
Incidence of anti-drug antibodies (ADA) will be measured
Measured: up to 90 days following last dose
Pharmacokinetics
Peak plasma concentration(Cmax)
Measured: Up to 48 weeks following first dose
Pharmacokinetics
Up to 48 weeks following first dose
Measured: Clearance（CL）
Pharmacokinetics
Apparent volumeof distribution（V）
Measured: Up to 48 weeks following first dose
Pharmacokinetics
Terminal Half Life（T1/2）
Measured: Up to 48 weeks following first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start27 Oct 2021
- Primary completion30 Aug 2023
- Study completion30 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Innovent Biologics (Suzhou) Co. Ltd.The sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043298
- Sponsor's protocol ID
- CIBI360A101
- Status last verified
- Oct 2024
- First submitted
- 5 Sep 2021
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib Open-Label, Multi-Center Clinical Trial to Evaluate Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI360 Monotherapy or in Combination With Sintilimab and (or) Chemotherapy in Advanced or Metastatic Solid Tumors
- ClinicalTrials.gov ID
- NCT05043298
- Acronym / sponsor ID
- CIBI360A101
- Conditions
- Advanced Solid Tumor
- Keywords
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Oct 2021 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Aug 2023 (actual)
- First posted
- 14 Sep 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.
This is an open label Phase Ia/Ib trial to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of IBI360 monotherapy in Advanced or Metastatic Solid Tumors
Detailed description
Phase Ia is dose escalation and dose expansion study of IBI360 monotherapy and IBI360 in combination with sintilimab in advanced or metastatic Solid Tumors; Phase Ib is an multi-cohort trial of pancreatic carcinoma, HER2 negative gastric adenocarcinoma, advanced or metastatic solid tumors to evaluate safety and preliminary efSficacy of IBI360 in combination with sintilimab and (or) chemotherapy or IBI360 monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBI360 | Experimental | Drug: IBI 360 Injection |
| IBI 360 + Sintilimab | Experimental | Drug: IBI 360 Injection Sintilimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Provide signed informed consent;
- Male or female aged at 18-75 (inclusive) years;
- Expected survival ≥12 weeks;
- ECOG PS score 0 or 1;
- Provide archival or fresh tissues for CLDN18.2 expression analysis;
Key exclusion criteria (8 listed)
- The subjects who received the treatment with CLDN18.2 monoclonal antibody or CLDN-18.2 CART;
- The subjects who received other anti-tumor medication within 4 weeks prior to the initial dose of the study drug;
- Any toxicity due to previous anti-tumor therapy that has not yet resolved to NCI CTCAE v5.0 grade 0 or 1 prior to the first dose of study treatment;
- The subjects with history of hypersensitivity to the study drug;
- The subjects were not recovery after surgery with history of gastrointestinal perforation or fistula within 6 months prior to the enrollment;
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 |
|---|---|---|
| IBI 360 InjectionIBI 360 dose level of escalation IV Q3W Day 1 | Drug | IBI360 |
| IBI 360 Injection SintilimabIBI 360 dose level of escalation IV Q3W Day 1 Sintilimab 200mg IV Q3W Day 1 | Drug | IBI 360 + Sintilimab |
Primary outcome
Safety and tolerance
Time frame: up to 90 days following last dose
Participant safety is characterized by frequency and severity of adverse events(according to NCI CTCAE 5.0)
Recommended Phase 2 Dose (RP2D)
Time frame: up to 21 days following last dose level
A recommended phase 2 dose will be determined based on safety data including dose limiting toxicities, preliminary efficacy data, and PK data
7 secondary outcomes
Efficacy
Time frame: Subjects were randomized 6 months and 1 year later
Pharmacokinetics
Time frame: Up to 48 weeks following first dose
Immunogenicity
Time frame: up to 90 days following last dose
Pharmacokinetics
Time frame: Up to 48 weeks following first dose
Pharmacokinetics
Time frame: Clearance（CL）
Pharmacokinetics
Time frame: Up to 48 weeks following first dose
Pharmacokinetics
Time frame: Up to 48 weeks following first dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Advanced Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
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 IBI 360 Injection and IBI 360 Injection Sintilimab in people with Advanced Solid Tumor, run by Innovent Biologics (Suzhou) Co. 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 9 inclusion and 8 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: finished, as of the sponsor's last update on 17 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and tolerance (time frame: up to 90 days following last dose). 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 17 Oct 2024; AzTrials last refreshed its copy on 7 Nov 2026.