Solid TumorPhase 1NCT05119998
A Phase I Study of IBI325 in Patients With Advanced Solid Tumor
A Phase 1 study testing IBI325 + sintilimab and IBI325 in people with Solid Tumor, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI325 in patients with advanced solid tumors Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Solid Tumor
- What is being tested?
- IBI325 + sintilimab and IBI325
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 8 Feb 2022to 8 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
- Histologically confirmed, locally advanced unresectable or metastatic tumors.
- At least one evaluable or measurable lesion per RECIST 1.1
- Male or female subject at least 18 years old and no more than 75 years old.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.
- Must have adequate organ function
- Be able to provide archived or fresh tumor tissues-
Who cannot join
- Previous exposure to any anti-CD73 monoclonal antibody
- Subjects participating in another interventional clinical study, except for during the survival follow-up phase of the studies.
- Unstable central nervous system netastases
- Known active autoimmune disease or inflammatory disease
- Known active infectious disease
- Other uncontrolled systematic disease that may increase the risk of participating the study-
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Open-label, Multicenter, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI325, an Anti-CD73 Antibody, in Patients With Advanced Solid Tumor
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI325 in patients with advanced solid tumors
- Conditions
- Solid Tumor
- Being tested
- IBI325 + sintilimab, IBI325
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI325 + sintilimabDrug
IBI325 + sintilimab combination does-escalation Patients will receive IBI325 and sintilimab until progressive disease, intolerability, or other reasons leading to treatment discontinuation
IBI325Drug
IBI325 monotherapy does-escalation Patients will receive IBI325 until progressive disease, intolerability, or other reasons leading to treatment discontinuation
| Study group | Role | What they receive |
|---|---|---|
| IBI325 and sintilimab combination does-escalation | Experimental | Not described Receives: Drug: IBI325 + sintilimab |
| IBI325 monotherapy does-escalation | Experimental | Not described Receives: Drug: IBI325 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with DLT
Number of patients who experienced a dose-limiting toxicity within the first 28 days after the first dose
Measured: 28 days post first dose
Number of patients with treatment related AEs
Number of patients who experienced a treatment related AEs from the first dose until 90days after the last dose
Measured: Up to 90 days post last dose
Secondary outcomes (6)
Number of patients with response
Number of patients with response per RECIST 1.1
Measured: Every 6 weeks until progressive disease or up to 24 months after treatment
The area under the curve (AUC)
Measured: Up to 90 days post last dose
Maximum concentration (Cmax)
Measured: Up to 90 days post last dose
Time at which maximum concentration (Tmax)
Measured: Up to 90 days post last dose
The half-life (t1/2)
Measured: Up to 90 days post last dose
Positive rate of ADA and Nab
Measured: Up to 90 days post last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start8 Feb 2022
- Primary completion27 Jul 2023
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 48 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
- NCT05119998
- Sponsor's protocol ID
- CIBI325A101
- Status last verified
- Oct 2022
- First submitted
- 3 Nov 2021
- Last updated
- 18 Aug 2023
- 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 18 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open-label, Multicenter, Dose-escalation Study Evaluating the Safety, Tolerability, and Potential Efficacy of IBI325, an Anti-CD73 Antibody, in Patients With Advanced Solid Tumor
- ClinicalTrials.gov ID
- NCT05119998
- Acronym / sponsor ID
- CIBI325A101
- Conditions
- Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 15 Nov 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.
The primary objective of this phase I study is to evaluate the safety and potential efficacy and to determine the recommended phase 2 dose (RP2D) of IBI325 in patients with advanced solid tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBI325 and sintilimab combination does-escalation | Experimental | Drug: IBI325 + sintilimab |
| IBI325 monotherapy does-escalation | Experimental | Drug: IBI325 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically confirmed, locally advanced unresectable or metastatic tumors.
- At least one evaluable or measurable lesion per RECIST 1.1
- Male or female subject at least 18 years old and no more than 75 years old.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.
- Must have adequate organ function
Key exclusion criteria (6 listed)
- Previous exposure to any anti-CD73 monoclonal antibody
- Subjects participating in another interventional clinical study, except for during the survival follow-up phase of the studies.
- Unstable central nervous system netastases
- Known active autoimmune disease or inflammatory disease
- Known active infectious 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 |
|---|---|---|
| IBI325 + sintilimabIBI325 + sintilimab combination does-escalation Patients will receive IBI325 and sintilimab until progressive disease, intolerability, or other reasons leading to treatment discontinuation | Drug | IBI325 and sintilimab combination does-escalation |
| IBI325IBI325 monotherapy does-escalation Patients will receive IBI325 until progressive disease, intolerability, or other reasons leading to treatment discontinuation | Drug | IBI325 monotherapy does-escalation |
Primary outcome
Number of patients with DLT
Time frame: 28 days post first dose
Number of patients who experienced a dose-limiting toxicity within the first 28 days after the first dose
Number of patients with treatment related AEs
Time frame: Up to 90 days post last dose
Number of patients who experienced a treatment related AEs from the first dose until 90days after the last dose
6 secondary outcomes
Number of patients with response
Time frame: Every 6 weeks until progressive disease or up to 24 months after treatment
The area under the curve (AUC)
Time frame: Up to 90 days post last dose
Maximum concentration (Cmax)
Time frame: Up to 90 days post last dose
Time at which maximum concentration (Tmax)
Time frame: Up to 90 days post last dose
The half-life (t1/2)
Time frame: Up to 90 days post last dose
Positive rate of ADA and Nab
Time frame: Up to 90 days post last 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 18 Aug 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.
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 IBI325 + sintilimab and IBI325 in people with 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 6 inclusion and 6 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 18 Aug 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. 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?
Number of patients with DLT (time frame: 28 days post first 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 18 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.