Advanced MalignanciesPhase 1NCT05245916
IBI397 or Combination Therapies in Patients With Advanced Malignancies
A Phase 1 study testing IBI397, IBI397+Sintilimab and IBI397+Rituximab in people with Advanced Malignancies, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
The primary objective of this phase Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI397 or its Combination Therapies in Patients with Advanced Malignancies 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?
- IBI397, IBI397+Sintilimab and IBI397+Rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 14 Apr 2022to 24 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
- Have failed the standard treatment for locally advanced, recurrent or metastatic solid tumor or have failed at least the second line standard treatment (including autologous stem cell transplantation) or have failed the first line standard treatment and are not eligible for autologous stem cell transplantation
- Willing to and able to provide written informed consent for the trial and able to comply with protocol-specified visits and related procedures
- ≥ 18 and ≤ 75 years of age on the day of signing the informed consent
- Have a performance scale of 0 or 1 on the Eastern Cooperative Oncology Group Performance Status (ECOG PS)
- Subjects with solid tumor: Have at least one measurable or assessable lesion as defined by RECIST v1.1; Subjects with lymphoma: Have at least one measurable or assessable lesion as defined by Lugano2014 criteria
Who cannot join
- Has been previously exposed to any CD47 antibody, SIRPα antibody, or CD47/SIRPα recombinant protein or other inhibitors that target the same pathway
- Is currently participating in another interventional study, except for observational (non-interventional) study or in the survival follow-up phase of an interventional study
- Requires long-term systemic hormone or any other immunosuppressive drug therapy, excluding inhaled hormone therapy
- Has acute or chronic active hepatitis B (defined as hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody positive [HBcAb] and hepatitis B virus [HBV] DNA copy number ≥ 1 × 104 copies/ml or ≥ 2000 IU/ml or higher than the lower limit of detection) or acute or chronic active hepatitis C virus (HCV) antibody positive; HCV antibody positive but RNA negative subjects are allowed
- Has a known history of severe allergic reaction to other monoclonal antibodies, or is allergic to any component of the IBI397 formulation.
- Is pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
China1 site
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300200
About this study
Official title: A Phase Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI397 or Combination Therapies in Patients With Advanced Malignancies
The primary objective of this phase Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI397 or its Combination Therapies in Patients with Advanced Malignancies
- Conditions
- Advanced Malignancies
- Being tested
- IBI397, IBI397+Sintilimab, IBI397+Rituximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI397Drug
IBI397 single-agent dose escalation： Subjects will receive IBI397 until disease progression, unacceptable toxicity, withdrawal of consent, occurrence of other conditions that require discontinuation of study treatment, or the treatment duration has reached 24 months, whichever occurs first
IBI397+SintilimabDrug
IBI397 in combination with sintilimab： Subjects will receive IBI397 combination therapy with sintilimab until disease progression, unacceptable toxicity, withdrawal of consent, occurrence of other conditions that require discontinuation of study treatment, or the treatment duration has reached 24 months, whichever occurs first
IBI397+RituximabDrug
IBI397 in combination with rituximab： Subjects will receive IBI397 combination therapy with rituximab until disease progression, unacceptable toxicity, withdrawal of consent, occurrence of other conditions that require discontinuation of study treatment, or the treatment duration has reached 24 months, whichever occurs first
| Study group | Role | What they receive |
|---|---|---|
| IBI397 single-agent dose escalation | Experimental | Not described Receives: Drug: IBI397 |
| IBI397+ Rituximab | Experimental | Not described Receives: Drug: IBI397; Drug: IBI397+Rituximab |
| IBI397 + Sintilimab | Experimental | Not described Receives: Drug: IBI397; Drug: IBI397+Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with treatment related AEs
Number of patients who experienced a treatment related AEs from the frist dose until 90 days after the last dose
Measured: Up to 90 days post last dose
Percentage of Subjects with Dose-Limiting Toxicities (DLTs)
To evaluate the safety and tolerability of IBI397 alone or in combination with Sintilimab
Measured: Up to 28 Days following first dose
Secondary outcomes (7)
area under the plasma concentration-time curve (AUC)
Measured: Up to 90 days post last dose
maximum concentration (Cmax)
Measured: Up to 90 days post last dose
clearance (CL)
Measured: Up to 90 days post last dose
volume of distribution (V)
Measured: Up to 90 days post last dose
half-life (t1/2)
Measured: Up to 90 days post last dose
anti-drug antibody (ADA)
Number of Anti-Drug Antibodies (ADA) positive subjects will be counted and percentage of ADA positive subjects will be calculated to evaluate immunogenicity of IBI397
Measured: Up to 90 days post last dose
Objective response rate (ORR)
Objective Response Rate (ORR) is the percentage of Complete Response (CR) plus partial response (PR) assessed per RECIST v1.1 criteria for solid tumors or per Lugano2014 criteria for lymphomas
Measured: Up to 2 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start14 Apr 2022
- Primary completion24 Aug 2023
- Study completion24 Aug 2023
Why it stopped: Due to the company's development strategy adjustment
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 0 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
- NCT05245916
- Sponsor's protocol ID
- CIBI397A101
- Status last verified
- Aug 2023
- First submitted
- 26 Jan 2022
- Last updated
- 5 Sep 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 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI397 or Combination Therapies in Patients With Advanced Malignancies
- ClinicalTrials.gov ID
- NCT05245916
- Acronym / sponsor ID
- CIBI397A101
- Conditions
- Advanced Malignancies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the company's development strategy adjustment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Apr 2022 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 18 Feb 2022 (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 Ia/Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of IBI397 or its Combination Therapies in Patients with Advanced Malignancies
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IBI397 single-agent dose escalation | Experimental | Drug: IBI397 |
| IBI397+ Rituximab | Experimental | Drug: IBI397, Drug: IBI397+Rituximab |
| IBI397 + Sintilimab | Experimental | Drug: IBI397, Drug: IBI397+Sintilimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have failed the standard treatment for locally advanced, recurrent or metastatic solid tumor or have failed at least the second line standard treatment (including autologous stem cell transplantation) or have failed the first line standard treatment and are not eligible for autologous stem cell transplantation
- Willing to and able to provide written informed consent for the trial and able to comply with protocol-specified visits and related procedures
- ≥ 18 and ≤ 75 years of age on the day of signing the informed consent
- Have a performance scale of 0 or 1 on the Eastern Cooperative Oncology Group Performance Status (ECOG PS)
- Subjects with solid tumor: Have at least one measurable or assessable lesion as defined by RECIST v1.1; Subjects with lymphoma: Have at least one measurable or assessable lesion as defined by Lugano2014 criteria
Key exclusion criteria (6 listed)
- Has been previously exposed to any CD47 antibody, SIRPα antibody, or CD47/SIRPα recombinant protein or other inhibitors that target the same pathway
- Is currently participating in another interventional study, except for observational (non-interventional) study or in the survival follow-up phase of an interventional study
- Requires long-term systemic hormone or any other immunosuppressive drug therapy, excluding inhaled hormone therapy
- Has acute or chronic active hepatitis B (defined as hepatitis B surface antigen [HBsAg] and/or hepatitis B core antibody positive [HBcAb] and hepatitis B virus [HBV] DNA copy number ≥ 1 × 104 copies/ml or ≥ 2000 IU/ml or higher than the lower limit of detection) or acute or chronic active hepatitis C virus (HCV) antibody positive; HCV antibody positive but RNA negative subjects are allowed
- Has a known history of severe allergic reaction to other monoclonal antibodies, or is allergic to any component of the IBI397 formulation.
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 |
|---|---|---|
| IBI397IBI397 single-agent dose escalation： Subjects will receive IBI397 until disease progression, unacceptable toxicity, withdrawal of consent, occurrence of other conditions that require discontinuation of study treatment, or the treatment duration has reached 24 months, whichever occurs first | Drug | IBI397 + Sintilimab, IBI397 single-agent dose escalation, IBI397+ Rituximab |
| IBI397+SintilimabIBI397 in combination with sintilimab： Subjects will receive IBI397 combination therapy with sintilimab until disease progression, unacceptable toxicity, withdrawal of consent, occurrence of other conditions that require discontinuation of study treatment, or the treatment duration has reached 24 months, whichever occurs first | Drug | IBI397 + Sintilimab |
| IBI397+RituximabIBI397 in combination with rituximab： Subjects will receive IBI397 combination therapy with rituximab until disease progression, unacceptable toxicity, withdrawal of consent, occurrence of other conditions that require discontinuation of study treatment, or the treatment duration has reached 24 months, whichever occurs first | Drug | IBI397+ Rituximab |
Primary outcome
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 frist dose until 90 days after the last dose
Percentage of Subjects with Dose-Limiting Toxicities (DLTs)
Time frame: Up to 28 Days following first dose
To evaluate the safety and tolerability of IBI397 alone or in combination with Sintilimab
7 secondary outcomes
area under the plasma concentration-time curve (AUC)
Time frame: Up to 90 days post last dose
maximum concentration (Cmax)
Time frame: Up to 90 days post last dose
clearance (CL)
Time frame: Up to 90 days post last dose
volume of distribution (V)
Time frame: Up to 90 days post last dose
half-life (t1/2)
Time frame: Up to 90 days post last dose
anti-drug antibody (ADA)
Time frame: Up to 90 days post last dose
Objective response rate (ORR)
Time frame: Up to 2 years after enrollment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 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 IBI397, IBI397+Sintilimab and IBI397+Rituximab 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 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: withdrawn, as of the sponsor's last update on 5 Sep 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 was withdrawn before enrolling participants, so there are no results.
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 treatment related AEs (time frame: Up to 90 days post 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 5 Sep 2023.