Advanced Malignant Tumors LymphomasPhase 1NCT04338659
A Phase 1a Study Evaluating the Safety, Tolerability, and Efficacy of IBI322 in Subjects With Advanced Cancers
A Phase 1 study testing IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection in people with Advanced Malignant Tumors Lymphomas, run by Innovent Biologics (Suzhou) Co. Ltd. at 4 sites in United States.
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 years and older
- Conditions the study is for
- Advanced Malignant Tumors Lymphomas
- What is being tested?
- IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Jan 2021to 28 Feb 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with histologically/cytologically confirmed unresectable or metastatic solid tumors or relapsed/recurrent lymphomas for which there are no available therapies known to confer clinical benefit.
- At least one evaluable lesion in Part A or at least one measurable lesion in Part B.
- Male or female subject > 18 years old.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Must have adequate organ function including the following.
- Subjects with life expectancy ≥ 12 weeks.
- Female subjects of childbearing age or male subjects whose partners are women at childbearing age, need to use 2 highly effective contraceptive measures, including one barrier method, throughout the treatment period and 6 months after the treatment period.
- Willing to sign informed consent form and be able to comply with the study's rules and visits/related procedures.
Who cannot join
- Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
- Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies.
- Subjects who are on anticoagulants and/or require concomitant aspirin or other nonsteroids anti-inflammatory medications.
- Subjects who have a history of blood transfusion within 2 weeks prior to screening, or the use of erythropoietin (EPO), granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage-colony stimulating factor (GM-CSF), thrombopoietin (TPO) or IL-11 therapy.
- Subjects who received the last dose of antineoplastic therapy (chemotherapy, endocrine therapy, targeted therapy, immunotherapy or tumor embolization) within 4 weeks prior to the first dose of study drug. Subjects who received the last dose of radiotherapy within 3 weeks prior to the first dose of study drug.
- Subjects that received immunosuppressive drugs within 7 days prior to the first dose of study drug, excluding topical, intra-nasal, or inhaled glucocorticoids or systemic glucocorticoids (i.e. equivalent to no more than 10 mg prednisone/day) or other glucocorticoids of equivalent dosage through nasal spray, inhalation or other routes.
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- Any ongoing AEs Grade 2 or higher as per NCI CTCAE v5.0 directly attributed to prior anti-tumor treatment with the exception of residual hair loss and fatigue
- Subjects who received whole pelvic radiotherapy prior to the enrollment.
- Subjects with known cerebrospinal metastases and other known central nervous system metastases.
- Subjects with active or suspected autoimmune diseases or with a history of documented autoimmune disease over the past 2 years (subjects can be included in the study: vitiligo, psoriasis, alopecia or Grave's disease subjects who do not require systemic treatment within 2 years; hypothyroidism subjects who require only thyroid hormone replacement therapy, and type I diabetes subjects who require only insulin replacement therapy).
- Known history of primary immunodeficiency.
- Known history of active pulmonary tuberculosis.
- Known history of allogenic organ transplantation and hematopoietic stem cell transplantation.
- Known history of hypersensitivity to any components of the IBI322 injection.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The University of Texas MD Anderson Cancer Center - Investigational Cancer Therapies
Houston, Texas, 77030
University Of Mississippi Medical Center
Jackson, Mississippi, 39313
The Angeles Clinic And Research Institute
Los Angeles, California, 90025
The University of Kansas Cancer Center
Westwood, Kansas, 66205
About this study
Official title: A Phase 1a 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
A Phase 1a study evaluating the safety, tolerability and preliminary efficacy of IBI322 in subjects with advanced malignant tumors
- Conditions
- Advanced Malignant Tumors Lymphomas
- Being tested
- IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection
- Keywords
- Cancer, advanced malignancy, metastatic, solid tumor, lymphoma
- Medical subject headings
- Neoplasms, Neoplasm Metastasis, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injectionBiological
Also called IBI322
IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation of IBI322 | Experimental | Participants will receive escalating dose levels of IBI322 to determine maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of IBI322 Receives: Biological: IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity (DLT)
Measured: .Day 1 - Day 21
Treatment-related Adverse Events (TRAEs)
Measured: Day 1 - 90 days after last administration
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: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2020
- Study start14 Jan 2021
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Tumors LymphomasStudies 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 22 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
- NCT04338659
- Sponsor's protocol ID
- CIBI322A102
- 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
- Yes
- 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 Study Evaluating the Safety, Tolerability and Preliminary Efficacy of IBI322 in Subjects With Advanced Malignant Tumors
- ClinicalTrials.gov ID
- NCT04338659
- Acronym / sponsor ID
- CIBI322A102
- Conditions
- Advanced Malignant Tumors Lymphomas
- Keywords
- Cancer, advanced malignancy, metastatic, solid tumor, lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 8 Apr 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
A Phase 1a study evaluating the safety, tolerability and preliminary efficacy of IBI322 in subjects with advanced malignant tumors
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation of IBI322 | Experimental | Biological: IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injectionParticipants will receive escalating dose levels of IBI322 to determine maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of IBI322 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects with histologically/cytologically confirmed unresectable or metastatic solid tumors or relapsed/recurrent lymphomas for which there are no available therapies known to confer clinical benefit.
- At least one evaluable lesion in Part A or at least one measurable lesion in Part B.
- Male or female subject > 18 years old.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1.
- Must have adequate organ function including the following.
Key exclusion criteria (14 listed)
- Previous exposure to any anti-CD47 monoclonal antibody, SIRPα antibody, or CD47/SIRPα recombinant protein.
- Subjects participating in another interventional clinical study, except for: observational (non-interventional) clinical studies or survival follow-up phase of interventional studies.
- Subjects who are on anticoagulants and/or require concomitant aspirin or other nonsteroids anti-inflammatory medications.
- Subjects who have a history of blood transfusion within 2 weeks prior to screening, or the use of erythropoietin (EPO), granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage-colony stimulating factor (GM-CSF), thrombopoietin (TPO) or IL-11 therapy.
- Subjects who received the last dose of antineoplastic therapy (chemotherapy, endocrine therapy, targeted therapy, immunotherapy or tumor embolization) within 4 weeks prior to the first dose of study drug. Subjects who received the last dose of radiotherapy within 3 weeks prior to the first dose of study drug.
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 |
|---|---|---|
| IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injectionAlso: IBI322IBI322 Recombinant anti-human CD47/PD-L1 bispecific antibody injection | Biological | Dose Escalation of IBI322 |
Primary outcome
Dose Limiting Toxicity (DLT)
Time frame: .Day 1 - Day 21
Treatment-related Adverse Events (TRAEs)
Time frame: Day 1 - 90 days after last administration
6 secondary outcomes
PK parameters
Time frame: Up to 90 days post last dose
PK parameters
Time frame: Up to 90 days post last dose
PK parameters
Time frame: Up to 90 days post last dose
PK parameters
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: Through study completion, an average of 1 year
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.
4 sites 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 Recombinant anti-human CD47/PD-L1 bispecific antibody injection in people with Advanced Malignant Tumors Lymphomas, run by Innovent Biologics (Suzhou) Co. Ltd. at 4 sites in United States.
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 8 inclusion and 14 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 4 sites in United States. 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?
Dose Limiting Toxicity (DLT) (time frame: .Day 1 - Day 21). 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 10 Oct 2023.