Advanced or Metastatic NSCLCPhase 1NCT04177290
A PK Similarity Study of Two Sintilimab Products Produced by Different Processes in Advanced or Metastatic NSCLC Patients
A Phase 1 study testing Sintilimab (M1b) and Sintilimab (approved) in people with Advanced or Metastatic NSCLC, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
this is a phase I study comparing PK similarity of sintilimab by different production process (approved versus M1b) in Chinese advanced or metastatic NSCLC patients who have failed or been intolerant to at least one prior line of standard treatment Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Advanced or Metastatic NSCLC
- What is being tested?
- Sintilimab (M1b) and Sintilimab (approved)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 2 Apr 2020to 4 Sep 2022
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed locally advanced, recurrent or metastatic NSCLC patients who have received or been intolerant to at least one prior line of standard treatment.
- No EGFR mutation or ALK rearrangement.
- ECOG PS score 0 or 1.
- BMI ≥ 21.0kg/m2 and ≤ 26.0kg/m2
- Body weight ≥ 60.0kg and ≤ 75.0kg.
- Adequate organ function per protocol-defined criteria.
Who cannot join
- Exposure to any anti-PD-1, PD-L1, PD-L2 antibodies.
- Allergic to any component of sintilimab.
- Active autoimmune diseases.
- Clinically unstable central nervous system metastasis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I PK Similarity Study of Two Sintilimab Products Produced by Different Processes in Advanced or Metastatic NSCLC Patients
this is a phase I study comparing PK similarity of sintilimab by different production process (approved versus M1b) in Chinese advanced or metastatic NSCLC patients who have failed or been intolerant to at least one prior line of standard treatment
- Conditions
- Advanced or Metastatic NSCLC
- Being tested
- Sintilimab (M1b), Sintilimab (approved)
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sintilimab (M1b)Drug
Intravenous infusion
Sintilimab (approved)Drug
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| sintilimab (M1b) 200mg | Experimental | Not described Receives: Drug: Sintilimab (M1b) |
| sintilimab (approved) 200mg | Active comparator | Not described Receives: Drug: Sintilimab (approved) |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK is defined as AUC0-∞.
Measured: 28 days
Secondary outcomes (2)
PK is defined as Cmax.
Measured: 28 days
Safety of sintilimab (approved) versus sintilimab (M1b). AE is defined as treatment-related adverse events assessed by CTCAE v5.0.
Measured: from randomization through 90 days after last dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start2 Apr 2020
- Primary completion28 Feb 2021
- Study completion4 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic NSCLCStudies 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
- Randomised
- Intervention model
- Parallel groups
- 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
- NCT04177290
- Sponsor's protocol ID
- CIBI308K101
- Status last verified
- Feb 2023
- First submitted
- 14 Nov 2019
- Last updated
- 27 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 27 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I PK Similarity Study of Two Sintilimab Products Produced by Different Processes in Advanced or Metastatic NSCLC Patients
- ClinicalTrials.gov ID
- NCT04177290
- Acronym / sponsor ID
- CIBI308K101
- Conditions
- Advanced or Metastatic NSCLC
- 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
- 2 Apr 2020 (actual)
- Primary completion
- 28 Feb 2021 (actual)
- Study completion
- 4 Sep 2022 (actual)
- First posted
- 26 Nov 2019 (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 comparing PK similarity of sintilimab by different production process (approved versus M1b) in Chinese advanced or metastatic NSCLC patients who have failed or been intolerant to at least one prior line of standard treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sintilimab (M1b) 200mg | Experimental | Drug: Sintilimab (M1b) |
| sintilimab (approved) 200mg | Active comparator | Drug: Sintilimab (approved) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Histologically or cytologically confirmed locally advanced, recurrent or metastatic NSCLC patients who have received or been intolerant to at least one prior line of standard treatment.
- No EGFR mutation or ALK rearrangement.
- ECOG PS score 0 or 1.
- BMI ≥ 21.0kg/m2 and ≤ 26.0kg/m2
- Body weight ≥ 60.0kg and ≤ 75.0kg.
Key exclusion criteria (4 listed)
- Exposure to any anti-PD-1, PD-L1, PD-L2 antibodies.
- Allergic to any component of sintilimab.
- Active autoimmune diseases.
- Clinically unstable central nervous system metastasis.
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 |
|---|---|---|
| Sintilimab (M1b)Intravenous infusion | Drug | sintilimab (M1b) 200mg |
| Sintilimab (approved)Intravenous infusion | Drug | sintilimab (approved) 200mg |
Primary outcome
PK is defined as AUC0-∞.
Time frame: 28 days
2 secondary outcomes
PK is defined as Cmax.
Time frame: 28 days
Safety of sintilimab (approved) versus sintilimab (M1b). AE is defined as treatment-related adverse events assessed by CTCAE v5.0.
Time frame: from randomization through 90 days after last dosing
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 27 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 Sintilimab (M1b) and Sintilimab (approved) in people with Advanced or Metastatic NSCLC, 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 4 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 27 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?
PK is defined as AUC0-∞. (time frame: 28 days). 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 27 Feb 2023.