Advanced MalignanciesPhase 1NCT04328831
Safety and Efficacy of IBI322 in Chinese Subjects With Advanced Malignant Tumors
A Phase 1 study testing IBI322 in people with Advanced Malignancies, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in cancer subjects who failed standard treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Malignancies
- What is being tested?
- IBI322
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- 31 Jul 2020to 28 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/cytologically confirmed, locally advanced unresectable or metastatic tumors.
- At least one evaluable lesion.
- Male or female subject above 18 years old, no more than 75 years old.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) performance status 0 or 1.
- Must have adequate organ function
Who cannot join
- Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
- Previous exposure to any anti-programmed death receptor 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) /anti-programmed death ligand 2 (PD-L2) antibodies
- Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies.
- Patients who are on anticoagulants and /or require concomitant aspirin or other nonsteroids anti-inflammatory medications. Patients with a history of a bleeding diathesis (von Willebrand disease, end stage liver disease, hemophilia, etc.)
- Subjects who have a history of blood transfusion within 2 weeks prior to the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1a/1b Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Advanced Malignant Tumors
This is a phase I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in cancer subjects who failed standard treatment.
Read the detailed description
Phase 1a/Ib study will be conducted to evaluate the tolerability, safety, PK, PD, immunogenicity and preliminary antitumor activity of IBI322 in China. Phase 1a is dose escalation and plans to enroll approximately 38-60 subjects with advanced malignant solid tumors who failed the standard treatment. Phase Ib is dose expansion, and plans to enroll approximately 180 subjects with advanced malignant tumors.
- Conditions
- Advanced Malignancies
- Being tested
- IBI322
- Keywords
- Oncology
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI322Biological
Recombinant anti-human CD47/PD-L1 bispecific antibody injection
| Study group | Role | What they receive |
|---|---|---|
| IBI322 | Other | Single arm Receives: Biological: IBI322 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of DLT
Measured: 28 days
Number of treatment related AEs
Measured: 90 days post last dose
Number of patients with response
Measured: Last patient enrolled+24 weeks
Secondary outcomes (6)
PK parameters: The area under the curve (AUC)
Measured: Up to 90 days post last dose
PK parameters: Maximum concentration (Cmax)
Measured: Up to 90 days post last dose
PK parameters: Time at which maximum concentration (Tmax)
Measured: Up to 90 days post last dose
PK parameters: 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
Positive rate of Circulating Immune Complex
Measured: Up to last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2020
- Study start31 Jul 2020
- Primary completion28 Aug 2023
- Study completion28 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced MalignanciesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 94 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
- NCT04328831
- Sponsor's protocol ID
- CIBI322A101
- Status last verified
- Oct 2023
- First submitted
- 24 Mar 2020
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1a/1b Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT04328831
- Acronym / sponsor ID
- CIBI322A101
- Conditions
- Advanced Malignancies
- Keywords
- Oncology
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2020 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 31 Mar 2020 (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 I study evaluating the safety, tolerability and preliminary efficacy of IBI322 in cancer subjects who failed standard treatment.
Detailed description
Phase 1a/Ib study will be conducted to evaluate the tolerability, safety, PK, PD, immunogenicity and preliminary antitumor activity of IBI322 in China. Phase 1a is dose escalation and plans to enroll approximately 38-60 subjects with advanced malignant solid tumors who failed the standard treatment. Phase Ib is dose expansion, and plans to enroll approximately 180 subjects with advanced malignant tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IBI322 | Other | Biological: IBI322Single arm |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically/cytologically confirmed, locally advanced unresectable or metastatic tumors.
- At least one evaluable lesion.
- Male or female subject above 18 years old, 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 (5 listed)
- Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
- Previous exposure to any anti-programmed death receptor 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) /anti-programmed death ligand 2 (PD-L2) antibodies
- Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies.
- Patients who are on anticoagulants and /or require concomitant aspirin or other nonsteroids anti-inflammatory medications. Patients with a history of a bleeding diathesis (von Willebrand disease, end stage liver disease, hemophilia, etc.)
- Subjects who have a history of blood transfusion within 2 weeks prior to 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 |
|---|---|---|
| IBI322Recombinant anti-human CD47/PD-L1 bispecific antibody injection | Biological | IBI322 |
Primary outcome
Number of DLT
Time frame: 28 days
Number of treatment related AEs
Time frame: 90 days post last dose
Number of patients with response
Time frame: Last patient enrolled+24 weeks
6 secondary outcomes
PK parameters: The area under the curve (AUC)
Time frame: Up to 90 days post last dose
PK parameters: Maximum concentration (Cmax)
Time frame: Up to 90 days post last dose
PK parameters: Time at which maximum concentration (Tmax)
Time frame: Up to 90 days post last dose
PK parameters: 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
Positive rate of Circulating Immune Complex
Time frame: Up to 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 10 Oct 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.
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 IBI322 in people with Advanced Malignancies, 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 5 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: finished, as of the sponsor's last update on 10 Oct 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 DLT (time frame: 28 days). The study lists 3 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 10 Oct 2023.