Advanced Cutaneous Squamous Cell CarcinomaPhase 1/2NCT04611321
Study of IBI318 in Patients With Advanced Cutaneous Squamous Cell Carcinoma
A Phase 1/2 study testing IBI318 in people with Advanced Cutaneous Squamous Cell Carcinoma, run by Innovent Biologics (Suzhou) Co. Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of IBI318 (anti-PD-1/PD-L1) in adult participants with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC that is not amenable to surgery and/or radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Cutaneous Squamous Cell Carcinoma
- What is being tested?
- IBI318
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 10 Mar 2023
- Phase
- Phase 1/2
- 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
- Able to understand and willing to sign the ICF.
- Adults 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy at least 12 weeks.
- Adequate organ and bone marrow function.
- Histologically confirmed diagnosis of invasive CSCC. .
Who cannot join
- Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
- Any investigational drugs received within 4 weeks prior to the first study treatment.
- Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.
- History of autoimmune disease , present active autoimmune disease or inflammatory diseases
- Pregnant or nursing females.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib/II, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of IBI318 in Participants With Advanced Cutaneous Squamous Cell Carcinoma.
The purpose of this study is to evaluate the safety and efficacy of IBI318 (anti-PD-1/PD-L1) in adult participants with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC that is not amenable to surgery and/or radiation.
- Being tested
- IBI318
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBI318Drug
IBI318 will be given fixed dose via intravenous (IV) infusion on Day 1 of each 14-day cycle until disease progression or loss of clinical benefit.
| Study group | Role | What they receive |
|---|---|---|
| Phase Ib/II | Experimental | Patients with advanced CSCC. IBI318 administered intravenously every 2 weeks. Receives: Drug: IBI318 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate ( evaluated by the independent review committee according to RECIST V1.1; 0-100%). Higher scores mean a better outcome
RECIST version 1.1 will be used to determine ORR by IRRC
Measured: 24 months
Secondary outcomes (5)
Investigator Assessments of Overall Response Rate
RECIST version 1.1 will be used to determine ORR by investigator
Measured: 24 months
Duration of response
RECIST version 1.1 will be used to determine DOR by investigator and IRRC
Measured: 24 months
PFS (progression-free survival)
RECIST version 1.1 will be used to determine PFS by investigator and IRRC
Measured: 24 months
Overall Survival
Measured: 24 months
AEs and SAEs
To evaluate the safety and tolerability of IBI318 [Adverse events (AEs), Serious Adverse Events (SAEs) ]
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start1 Dec 2020
- Primary completion10 Mar 2023
- Study completion10 Mar 2023
Why it stopped: Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Cutaneous Squamous Cell CarcinomaStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 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
- NCT04611321
- Sponsor's protocol ID
- CIBI318A201
- Status last verified
- Mar 2023
- First submitted
- 27 Oct 2020
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib/II, Open-Label, Single Arm Study to Evaluate the Safety and Efficacy of IBI318 in Participants With Advanced Cutaneous Squamous Cell Carcinoma.
- ClinicalTrials.gov ID
- NCT04611321
- Acronym / sponsor ID
- CIBI318A201
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Innovent Biologics (Suzhou) Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 10 Mar 2023 (actual)
- Study completion
- 10 Mar 2023 (actual)
- First posted
- 2 Nov 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.
The purpose of this study is to evaluate the safety and efficacy of IBI318 (anti-PD-1/PD-L1) in adult participants with metastatic (nodal or distant) cutaneous squamous cell carcinoma (CSCC), or unresectable locally advanced CSCC that is not amenable to surgery and/or radiation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase Ib/II | Experimental | Drug: IBI318Patients with advanced CSCC. IBI318 administered intravenously every 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Able to understand and willing to sign the ICF.
- Adults 18 years of age or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy at least 12 weeks.
- Adequate organ and bone marrow function.
Key exclusion criteria (5 listed)
- Prior treatment with an agent that blocks the PD-1/PD-L1 pathway.
- Any investigational drugs received within 4 weeks prior to the first study treatment.
- Receive the last dose of anti-tumor therapy within 4 weeks before the first dose of study therapy.
- History of autoimmune disease , present active autoimmune disease or inflammatory diseases
- Pregnant or nursing females.
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 |
|---|---|---|
| IBI318IBI318 will be given fixed dose via intravenous (IV) infusion on Day 1 of each 14-day cycle until disease progression or loss of clinical benefit. | Drug | Phase Ib/II |
Primary outcome
Overall Response Rate ( evaluated by the independent review committee according to RECIST V1.1; 0-100%). Higher scores mean a better outcome
Time frame: 24 months
RECIST version 1.1 will be used to determine ORR by IRRC
5 secondary outcomes
Investigator Assessments of Overall Response Rate
Time frame: 24 months
Duration of response
Time frame: 24 months
PFS (progression-free survival)
Time frame: 24 months
Overall Survival
Time frame: 24 months
AEs and SAEs
Time frame: 30 months
Results and safety
The study was stopped early (reason given: Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 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 1/2 study testing IBI318 in people with Advanced Cutaneous Squamous Cell Carcinoma, 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 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: stopped early, as of the sponsor's last update on 28 Mar 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 stopped early (reason given: Due to the company's development strategy adjustment, Innovent Biologics has decided not to continue this study after consultation with investigators.). Results are not available in the source record.
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?
Overall Response Rate ( evaluated by the independent review committee according to RECIST V1.1; 0-100%). Higher scores mean a better outcome (time frame: 24 months). 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 28 Mar 2023.