Advanced Solid TumorPhase 1NCT03758001
First in Human Study of IBI101 in Chinese Subjects With Advanced Solid Tumors
A Phase 1 study testing IBI101 and Sintilimab in people with Advanced Solid Tumor, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
Phase 1a/1b Trial to evaluate the tolerability and safety of IBI101 monotherapy or in combination with Sintilimab in advanced solid tumor patients. 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?
- IBI101 and Sintilimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteChina
- Study dates
- 13 Feb 2019to 16 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with locally advanced, recurrent or metastatic solid tumors who have failed standard treatment
- 18 to 75 years old
- Life expectancy ≥ 12 weeks
- At least 1 measurable lesion
- ECOG PS score 0 or 1
- Adequate organ and bone marrow function
Who cannot join
- Previous exposure to anti-OX40, anti-PD-1, anti-PD-L1, anti-PD-L2 antibody or other immune checkpoint inhibitors
- Exposure to any other investigational drug in the 4 weeks prior to 1st dose of investigational drug
- Exposure to anti-tumor agents in the 3 weeks prior to 1st dose of investigational drug
- Exposure to immunosuppressant in the 3 weeks prior to 1st dose of investigational drug
- Major surgery in the 4 weeks prior to 1st dose of investigational drug
- 30Gy radiation in the chest in the 6 months prior to 1st dose of investigational drug
- History of autoimmune disease
- Symptomatic CNS metastasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase Ia/Ib Trial to Evaluate the Tolerability and Safety of IBI101 Monotherapy or in Combination With Sintilimab in Advanced Solid Tumor Patients
Phase 1a/1b Trial to evaluate the tolerability and safety of IBI101 monotherapy or in combination with Sintilimab in advanced solid tumor patients.
Read the detailed description
IBI101 and Sintilimab will be administered intravenously on Day 1 of every 21-day cycle. The DLT observation period is 21 days starting with the first dose taken on day 1. In the Phase Ia study, eight dose levels of IBI101 (0.01, 0.1, 0.3, 1, 3, 6, 10 and 15mg/kg) will be tested. In the Phase Ib study, four dose levels of IBI101 (1, 3, 6 and 10mg/kg), in combination with Sintilimab 200mg, will be tested. After completion of the dose escalation phase, two combination dose cohorts (IBI101 3mg/kg and 6mg/kg, in combination with Sintilimab 200mg) will be expanded to 10 patients each.
IBI101 is a recombinant fully humanized IgG1 anti-tumor necrosis factor receptor superfamily member 4 (OX40) monoclonal antibody.
Sintilimab is a recombinant fully humanized anti-programmed death 1 (PD1) monoclonal antibody.
- Conditions
- Advanced Solid Tumor
- Being tested
- IBI101, Sintilimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI101Drug
0.01 mg/kg; 0.1 mg/kg; 0.3 mg/kg; 1 mg/kg; 3 mg/kg; 6 mg/kg; 10 mg/kg; 15 mg/kg iv infusion day 1 of every 21 days
IBI101Drug
1 mg/kg; 3 mg/kg; 6 mg/kg; 10 mg/kg iv infusion day 1 of every 21 days
SintilimabDrug
Also called IBI308
200mg iv infusion day 1 of every 21 days
| Study group | Role | What they receive |
|---|---|---|
| IBI101 | Experimental | IBI101 will be administrated intravenously. 3+3 dose escalation design will be used with eight dose levels being tested. Receives: Drug: IBI101 |
| IBI101 in combination with Sintilimab | Experimental | IBI101 and Sintilimab will be administrated intravenously. 3+3 dose escalation design will be used with 4 dose levels of IBI101 being tested.
Two dose levels of IBI101 in combination with Sintilimab will be expanded to 10 patients each. Receives: Drug: IBI101; Drug: Sintilimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incicende of Adverse Events (AEs)
Number of patients with AE, treatment-related AE (TRAE), immune-related AEs (irAE), AE of special interest (AESI), serious adverse event (SAE), discontinuation of study drug due to AE, dose-limiting toxicity (DLT) assessed by CTCAE v5.0.
Measured: 2 years
Secondary outcomes (15)
Overall response rate (ORR)
Measured: 2 years
Time to response (TTR)
Measured: 2 years
Duration of response (DOR)
Measured: 2 years
Progression free survival (PFS)
Measured: 2 years
Area Under Curve (AUC)last and AUC0-inf
Measured: 2 years
Maximum Concentration (Cmax)
Measured: 2 years
Total body clearance (CL)
Measured: 2 years
Volume of distribution (Vz)
Measured: 2 years
Time at which maximum concentration occurred (Tmax)
Measured: 2 years
Elimination half-life (t1/2)
Measured: 2 years
Mean residue time (MRT)
Measured: 2 years
OX40 receptor occupancy
Measured: 2 years
T cell subset analysis
Measured: 2 years
Anti-drug antibody (ADA)
Measured: 2 years
Neutralizing antibody (Nab) positive rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start13 Feb 2019
- Primary completion16 Feb 2023
- Study completion16 Feb 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 38 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
- NCT03758001
- Sponsor's protocol ID
- CIBI101A101
- Status last verified
- Feb 2023
- First submitted
- 1 Nov 2018
- Last updated
- 22 Feb 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 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase Ia/Ib Trial to Evaluate the Tolerability and Safety of IBI101 Monotherapy or in Combination With Sintilimab in Advanced Solid Tumor Patients
- ClinicalTrials.gov ID
- NCT03758001
- Acronym / sponsor ID
- CIBI101A101
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Feb 2019 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 29 Nov 2018 (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.
Phase 1a/1b Trial to evaluate the tolerability and safety of IBI101 monotherapy or in combination with Sintilimab in advanced solid tumor patients.
Detailed description
IBI101 and Sintilimab will be administered intravenously on Day 1 of every 21-day cycle. The DLT observation period is 21 days starting with the first dose taken on day 1. In the Phase Ia study, eight dose levels of IBI101 (0.01, 0.1, 0.3, 1, 3, 6, 10 and 15mg/kg) will be tested. In the Phase Ib study, four dose levels of IBI101 (1, 3, 6 and 10mg/kg), in combination with Sintilimab 200mg, will be tested. After completion of the dose escalation phase, two combination dose cohorts (IBI101 3mg/kg and 6mg/kg, in combination with Sintilimab 200mg) will be expanded to 10 patients each.
IBI101 is a recombinant fully humanized IgG1 anti-tumor necrosis factor receptor superfamily member 4 (OX40) monoclonal antibody.
Sintilimab is a recombinant fully humanized anti-programmed death 1 (PD1) monoclonal antibody.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IBI101 | Experimental | Drug: IBI101IBI101 will be administrated intravenously. 3+3 dose escalation design will be used with eight dose levels being tested. |
| IBI101 in combination with Sintilimab | Experimental | Drug: IBI101, Drug: SintilimabIBI101 and Sintilimab will be administrated intravenously. 3+3 dose escalation design will be used with 4 dose levels of IBI101 being tested. Two dose levels of IBI101 in combination with Sintilimab will be expanded to 10 patients each. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with locally advanced, recurrent or metastatic solid tumors who have failed standard treatment
- 18 to 75 years old
- Life expectancy ≥ 12 weeks
- At least 1 measurable lesion
- ECOG PS score 0 or 1
Key exclusion criteria (8 listed)
- Previous exposure to anti-OX40, anti-PD-1, anti-PD-L1, anti-PD-L2 antibody or other immune checkpoint inhibitors
- Exposure to any other investigational drug in the 4 weeks prior to 1st dose of investigational drug
- Exposure to anti-tumor agents in the 3 weeks prior to 1st dose of investigational drug
- Exposure to immunosuppressant in the 3 weeks prior to 1st dose of investigational drug
- Major surgery in the 4 weeks prior to 1st dose of investigational 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 |
|---|---|---|
| IBI1010.01 mg/kg; 0.1 mg/kg; 0.3 mg/kg; 1 mg/kg; 3 mg/kg; 6 mg/kg; 10 mg/kg; 15 mg/kg iv infusion day 1 of every 21 days | Drug | IBI101 |
| IBI1011 mg/kg; 3 mg/kg; 6 mg/kg; 10 mg/kg iv infusion day 1 of every 21 days | Drug | IBI101 in combination with Sintilimab |
| SintilimabAlso: IBI308200mg iv infusion day 1 of every 21 days | Drug | IBI101 in combination with Sintilimab |
Primary outcome
Incicende of Adverse Events (AEs)
Time frame: 2 years
Number of patients with AE, treatment-related AE (TRAE), immune-related AEs (irAE), AE of special interest (AESI), serious adverse event (SAE), discontinuation of study drug due to AE, dose-limiting toxicity (DLT) assessed by CTCAE v5.0.
15 secondary outcomes
Overall response rate (ORR)
Time frame: 2 years
Time to response (TTR)
Time frame: 2 years
Duration of response (DOR)
Time frame: 2 years
Progression free survival (PFS)
Time frame: 2 years
Area Under Curve (AUC)last and AUC0-inf
Time frame: 2 years
Maximum Concentration (Cmax)
Time frame: 2 years
Total body clearance (CL)
Time frame: 2 years
Volume of distribution (Vz)
Time frame: 2 years
Time at which maximum concentration occurred (Tmax)
Time frame: 2 years
Elimination half-life (t1/2)
Time frame: 2 years
Mean residue time (MRT)
Time frame: 2 years
OX40 receptor occupancy
Time frame: 2 years
T cell subset analysis
Time frame: 2 years
Anti-drug antibody (ADA)
Time frame: 2 years
Neutralizing antibody (Nab) positive rate
Time frame: 2 years
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 22 Feb 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 IBI101 and 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 6 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 22 Feb 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?
Incicende of Adverse Events (AEs) (time frame: 2 years). 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 22 Feb 2023.