Neoplasm MalignantPhase 1NCT05296772
Phase 1 First-in-human Study of JS014
A Phase 1 study testing JS014, Interleukin 21 and humanized anti-human serum albumin VHH antibody and Pembrolizumab - anti-PD-1 antibody in people with Neoplasm Malignant and Neoplasm, Experimental, run by Anwita Biosciences at 2 sites in Taiwan.
Trial summary
This phase 1, first-in-human study uses a BOIN design to assess the safety and potential efficacy of JS014 at different dose levels as a single agent and in combination with fixed dose of pembrolizumab in subjects with advanced cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm Malignant, Neoplasm, Experimental, Solid Tumor, Adult
- What is being tested?
- JS014, Interleukin 21 and humanized anti-human serum albumin VHH antibody and Pembrolizumab - anti-PD-1 antibody
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTaiwan
- Study dates
- 28 Feb 2022to Jan 2025
- 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
- Older 18 years of age or per local regulation
- Subjects with advanced cancer or lymphoma who have no standard therapy available, ineligible for standard therapy or unwilling to receive cytotoxic therapy .
- ECOG PS 0-1
- A life expectancy longer than three months
- Adequate organ functions
- Able to adopt effective contraceptive measures
Who cannot join
- Known history of allergies to JS014 or IL-21 or human serum albumin or pembrolizumab (Ib only)
- Subjects who have received major surgery less than 4 weeks before 1st infusion of JS014
- Subjects who has a history of immune-related adverse events in prior immunotherapy.
- Subjects who have received immunosuppressive therapy less than 4 weeks before 1st infusion of JS014.
- Subjects who have two or more primary cancers in the past 5 years.
- Newly diagnosed or symptomatic brain metastases.
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- Subjects who have received prior anti-cancer therapy with residual toxicities greater than grade 2.
- Subjects who have a history of autoimmune disease in 2 years.
- Subjects who have active infection, or uncontrollable hypertension, unstable angina, active peptic ulcer, recent acute myocardial infarction, severe congestive heart failure, or unhealed wound.
- Subjects with active hepatitis B or hepatitis C.
- Subjects who are pregnant or breast feeding.
- Subjects who primary immune deficiency.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites, 2 recruiting
- Recruiting
Taipei Medical University -Shuang Ho Hospital
New Taipei City
Tracy Chui, tchui@zuelligpharma.com
Po-Ya Chuang, MD
- Recruiting
Wanfang Hospital -Taipei Medical University
Taipei, 106
HY Wang, 886-29307930 ext. 2543, 109093@w.tmu.edu.tw
About this study
Official title: A Phase 1 Study of JS014, a Recombinant Fusion Protein of Interleukin-21 and Humanized Anti-human Serum Albumin VHH Antibody as a Single Agent or in Combination With Pembrolizumab in Subjects With Advanced Cancer
This phase 1, first-in-human study uses a BOIN design to assess the safety and potential efficacy of JS014 at different dose levels as a single agent and in combination with fixed dose of pembrolizumab in subjects with advanced cancer.
Read the detailed description
This study has two parts: 1a and Ib. Ia is a single agent study, and Ib is a combination study, testing the safety of JS014 with 200 mg of pembrolizumab. After being informed about the study and the potential risks, all subjects giving written informed consent will receive at most 4-week screening procedures to ensure the eligibility of the study entry. Once eligible, the subjects will receive JS014 infusion at the designated dose levels once every week until disease progression. In Ia study, only JS014 is given. In Ib study, JS014 will be given once a week with pembrolizumab at 200 mg once every three weeks until disease progression. The subjects will receive safety evaluation, pharmacokinetic and pharmacodynamic studies, as well as efficacy evaluation at regular interval.
The maximum number in each part of the study is 30 subjects. The Ia study will be conducted in Taiwan, and Ib study will be conducted in both Taiwan and the United States.
- Being tested
- JS014, Interleukin 21 and humanized anti-human serum albumin VHH antibody, Pembrolizumab - anti-PD-1 antibody
- Keywords
- phase 1, JS014, first-in-human
- Medical subject headings
- Neoplasms, Neoplasms, Experimental, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JS014, Interleukin 21 and humanized anti-human serum albumin VHH antibodyBiological
Weekly infusion at the designated dose level until disease progression, withdrawal or up to two years
Pembrolizumab - anti-PD-1 antibodyBiological
Also called Keytruda
200 mg, once every three weeks until disease progression, withdrawal or up to two years
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Other | A open-label single arm of JS014 alone or in combination with pembrolizumab Receives: Biological: JS014, Interleukin 21 and humanized anti-human serum albumin VHH antibody; Biological: Pembrolizumab - anti-PD-1 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
The numbers of participants with treatment-related adverse events assessed by CTCAE 5.0
To determine the percentage of various toxicities assessed by CTCAE at different dose levels alone or in combination with pembrolizumab
Measured: 24 months
Maximum tolerated dose (MTD) of JS014
To determine the MTD of JS014 alone or in combination with pembrolizumab
Measured: 24 months
Recommended phase-2 dose (RP2D) of JS014
To determine of the RP2D of JS014 alone or in combination of pembrolizumab
Measured: 24 months
Secondary outcomes (10)
Area under the curve (AUC) of JS014
To estimate the AUC of JS014 at different dose levels alone or in combination with pembrolizumab
Measured: 24 months
Maximum concentration (Cmax) of JS014
To measure the Cmax after 1st and repeat dose of JS014 alone or in combination with pembrolizumab
Measured: 24 months
Clearance of JS014
To estimate the clearance of JS014 after 1st and repeat dose of JS014 alone or in combination with pembrolizumab
Measured: 24 months
Half life (T1/2) of JS014
To estimate the T1/2 at terminal phase of JS014 after 1st and repeat dose of JS014 alone or in combination with pembrolizumab
Measured: 24 months
Volume of distribution (Vd) of JS014
To estimate Vd of JS014 after 1st and repeat dose alone or in combination with pembrolizumab
Measured: 24 months
Time to reach maximum concentration (Tmax) of JS014
To estimate Tmax of JS014 after 1st and repeat dose of JS014 alone or in combination with pembrolizumab
Measured: 24 months
Overall response rate (ORR) alone or in combination with pembrolizumab
The assess the ORR of JS014 alone or in combination with pembrolizumab at different dose levels
Measured: 24 months
Duration of response (DoR) alone or in combination with pembrolizumab
To estimate the DoR at different dose levels alone or in combination with pembrolizumab
Measured: 24 months
Prevalence of anti-JS014 antibody
To estimate prevalence of anti-JS014 antibody at different dose levels alone or in combination with pembrolizumab
Measured: 24 months
Titers of anti-JS014 antibody
To measure the titer of anti-JS014 antibody alone or in combination with pembrolizumab at different dose levels during the study
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2022
- Study start28 Feb 2022
- Primary completionJun 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm MalignantStudies of the same condition, open and under way.
- 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
- Model description
- Single group assignment
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anwita Biosciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Shanghai Junshi Bioscience Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- TJ Chiou, MD, Principal investigator, Wanfang Hospital-Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05296772
- Sponsor's protocol ID
- AWT-EXK21-001
- Status last verified
- Sep 2023
- First submitted
- 28 Feb 2022
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of JS014, a Recombinant Fusion Protein of Interleukin-21 and Humanized Anti-human Serum Albumin VHH Antibody as a Single Agent or in Combination With Pembrolizumab in Subjects With Advanced Cancer
- ClinicalTrials.gov ID
- NCT05296772
- Acronym / sponsor ID
- AWT-EXK21-001
- Keywords
- phase 1, JS014, first-in-human
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Anwita BiosciencesIndustry (pharma, biotech, devices)
- Collaborators
- Shanghai Junshi Bioscience Co., Ltd.
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 25 Mar 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.
This phase 1, first-in-human study uses a BOIN design to assess the safety and potential efficacy of JS014 at different dose levels as a single agent and in combination with fixed dose of pembrolizumab in subjects with advanced cancer.
Detailed description
This study has two parts: 1a and Ib. Ia is a single agent study, and Ib is a combination study, testing the safety of JS014 with 200 mg of pembrolizumab. After being informed about the study and the potential risks, all subjects giving written informed consent will receive at most 4-week screening procedures to ensure the eligibility of the study entry. Once eligible, the subjects will receive JS014 infusion at the designated dose levels once every week until disease progression. In Ia study, only JS014 is given. In Ib study, JS014 will be given once a week with pembrolizumab at 200 mg once every three weeks until disease progression. The subjects will receive safety evaluation, pharmacokinetic and pharmacodynamic studies, as well as efficacy evaluation at regular interval.
The maximum number in each part of the study is 30 subjects. The Ia study will be conducted in Taiwan, and Ib study will be conducted in both Taiwan and the United States.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Other | Biological: JS014, Interleukin 21 and humanized anti-human serum albumin VHH antibody, Biological: Pembrolizumab - anti-PD-1 antibodyA open-label single arm of JS014 alone or in combination with pembrolizumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Older 18 years of age or per local regulation
- Subjects with advanced cancer or lymphoma who have no standard therapy available, ineligible for standard therapy or unwilling to receive cytotoxic therapy .
- ECOG PS 0-1
- A life expectancy longer than three months
- Adequate organ functions
Key exclusion criteria (12 listed)
- Known history of allergies to JS014 or IL-21 or human serum albumin or pembrolizumab (Ib only)
- Subjects who have received major surgery less than 4 weeks before 1st infusion of JS014
- Subjects who has a history of immune-related adverse events in prior immunotherapy.
- Subjects who have received immunosuppressive therapy less than 4 weeks before 1st infusion of JS014.
- Subjects who have two or more primary cancers in the past 5 years.
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 |
|---|---|---|
| JS014, Interleukin 21 and humanized anti-human serum albumin VHH antibodyWeekly infusion at the designated dose level until disease progression, withdrawal or up to two years | Biological | Dose escalation |
| Pembrolizumab - anti-PD-1 antibodyAlso: Keytruda200 mg, once every three weeks until disease progression, withdrawal or up to two years | Biological | Dose escalation |
Primary outcome
The numbers of participants with treatment-related adverse events assessed by CTCAE 5.0
Time frame: 24 months
To determine the percentage of various toxicities assessed by CTCAE at different dose levels alone or in combination with pembrolizumab
Maximum tolerated dose (MTD) of JS014
Time frame: 24 months
To determine the MTD of JS014 alone or in combination with pembrolizumab
Recommended phase-2 dose (RP2D) of JS014
Time frame: 24 months
To determine of the RP2D of JS014 alone or in combination of pembrolizumab
10 secondary outcomes
Area under the curve (AUC) of JS014
Time frame: 24 months
Maximum concentration (Cmax) of JS014
Time frame: 24 months
Clearance of JS014
Time frame: 24 months
Half life (T1/2) of JS014
Time frame: 24 months
Volume of distribution (Vd) of JS014
Time frame: 24 months
Time to reach maximum concentration (Tmax) of JS014
Time frame: 24 months
Overall response rate (ORR) alone or in combination with pembrolizumab
Time frame: 24 months
Duration of response (DoR) alone or in combination with pembrolizumab
Time frame: 24 months
Prevalence of anti-JS014 antibody
Time frame: 24 months
Titers of anti-JS014 antibody
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Individual participant dataSharing planned: No
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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.
TJ Chiou, MD principal investigator
Wanfang Hospital-Taipei Medical University
2 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 JS014, Interleukin 21 and humanized anti-human serum albumin VHH antibody and Pembrolizumab - anti-PD-1 antibody in people with Neoplasm Malignant and Neoplasm, Experimental, run by Anwita Biosciences at 2 sites in Taiwan.
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 12 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: status not confirmed, as of the sponsor's last update on 6 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 2 sites in Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact E Liu, MD ((650)660-9828, eliu@anwitabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The numbers of participants with treatment-related adverse events assessed by CTCAE 5.0 (time frame: 24 months). The study lists 3 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 6 Sep 2023.