Esophageal Squamous Cell CarcinomaPhase 2NCT03925870
KN046 in Subjects With Late Stage Esophageal Squamous Cell Carcinoma
A Phase 2 study testing KN046 in people with Esophageal Squamous Cell Carcinoma, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 1 site in China.
Trial summary
This is an open-label, multi-center, single arm study to evaluate the efficacy, safety and tolerability of KN046 in subjects with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC). The study is composed of 3 stages. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Squamous Cell Carcinoma
- What is being tested?
- KN046
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2019to 4 Jul 2022
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent form;
- 18 years of age or older, Male or female,
- Pathologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC)
- Had failed at front line regimen containing fluorouracil, paclitaxel and platinum. Disease progression within 6 months from previous adjuvant chemotherapy will be considered as failure of first line systemic therapy;
- Baseline measurable disease according to RECIST 1.1 from irradiated region or progressed within a previous radiation field;
- ECOG performance status of 0 or 1;
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- Have provided tumor tissue from locations not previously irradiated. Tumor biopsy may be from either the primary or metastatic site of disease;
- Adequate organ function assessed within 7 days prior to first trial treatment:
- Have a life expectancy of at least 3 months;
- If female of childbearing potential, have a negative serum pregnancy test within 7 days prior to first trial treatment;
- If female of childbearing potential or a male subject with a partner with childbearing potential, be willing to use a highly effective method of contraception (with a failure rate of less than 1.0% per year) from first study treatment to 24 weeks after completion of the trial treatment;
Who cannot join
- Untreated active CNS metastasis or leptomeningeal metastasis. Subjects may be eligible provided they are treated and clinically stable for at least 4 weeks and have no evidence of new or enlarging brain metastases and also are off steroids 7 days for treating brain metastasis prior to first trial treatment;
- Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks prior to the first dose of trial treatment;
- Has received other anti-tumor treatment, including traditional Chinese medicine which has approved anti-tumor indication within 4 weeks prior to the first trial treatment;
- Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and/or if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment;
- Curative radiation within 3 months of the first dose of trial treatment. Radiation to more than 30% of the bone marrow or with a wide field of radiation should not be used within 4 weeks prior to the first administration of trial treatment;
- Subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment (with the exception of subjects with adrenal insufficiency, who may continue corticosteroids at physiologic replacement doses, equivalent to < 10 mg prednisone daily, inhaled steroids and topical use of steroids);
- Vaccination within 28 days of the first administration of trial treatment, except for administration of inactivated vaccines (e.g., inactivated influenza vaccines);
- Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2 Study to Evaluate Efficacy, Safety and Tolerability of KN046 in Subjects With Advanced Unresectable or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
This is an open-label, multi-center, single arm study to evaluate the efficacy, safety and tolerability of KN046 in subjects with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC).
The study is composed of 3 stages. Stage 1 (Safety run-in period) will enroll approximately 6 subjects with KN046 3 mg/kg Q2W IV, for at least 4 cycles; thereafter, Scientific Monitoring Committee (SMC) will held to review the safety profiling data and decide whether proceed to stage 2 (Expansion period). Stage 2 will enroll up to 30 subjects. After completion of the enrollment from Stage 2 and all subjects have completed at least two post baseline tumor evaluation, an interim analysis will be performed for efficacy evaluation. SMC will continuously review the safety and clinical efficacy during the study and at the interim analysis and be responsible for the decision of proceeding to Stage 3 (Biomarker enrich period).
- Conditions
- Esophageal Squamous Cell Carcinoma
- Being tested
- KN046
- Medical subject headings
- Esophageal Squamous Cell Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN046Drug
Eligible subjects will be enrolled and receive KN046 (3 mg/kg) monotherapy treatment until progressive disease according to RECIST 1.1, unacceptable toxicity, completion of 2 years' KN046 treatment, or withdrawal of informed consent, whichever comes first
| Study group | Role | What they receive |
|---|---|---|
| KN046 monotherapy | Experimental | Eligible subjects will be enrolled and receive KN046 monotherapy treatment until progressive disease according to RECIST 1.1, unacceptable toxicity, completion of 2 years' KN046 treatment, or withdrawal of informed consent, whichever comes first. Receives: Drug: KN046 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response (OR)
Objective response (OR) per RECIST 1.1 criteria according to investigators assessment;
Measured: up to 2 years
Duration of response (DOR)
Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment;
Measured: up to 2 years
Secondary outcomes (3)
Clinical benefit rate
Clinical benefit rate
Measured: up to 2 years
Progression free survival (PFS) rates
Progression free survival (PFS) rates
Measured: 6 months and 12 months
Overall survival (OS) rates
Overall survival (OS) rates
Measured: 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start21 Jun 2019
- Primary completion26 Aug 2021
- Study completion4 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Jiangsu Alphamab Biopharmaceuticals Co., LtdThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925870
- Sponsor's protocol ID
- KN046-204
- Status last verified
- Aug 2022
- First submitted
- 27 Mar 2019
- Last updated
- 5 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Evaluate Efficacy, Safety and Tolerability of KN046 in Subjects With Advanced Unresectable or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)
- ClinicalTrials.gov ID
- NCT03925870
- Acronym / sponsor ID
- KN046-204
- Conditions
- Esophageal Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2019 (actual)
- Primary completion
- 26 Aug 2021 (actual)
- Study completion
- 4 Jul 2022 (actual)
- First posted
- 24 Apr 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 an open-label, multi-center, single arm study to evaluate the efficacy, safety and tolerability of KN046 in subjects with advanced unresectable or metastatic esophageal squamous cell carcinoma (ESCC).
The study is composed of 3 stages. Stage 1 (Safety run-in period) will enroll approximately 6 subjects with KN046 3 mg/kg Q2W IV, for at least 4 cycles; thereafter, Scientific Monitoring Committee (SMC) will held to review the safety profiling data and decide whether proceed to stage 2 (Expansion period). Stage 2 will enroll up to 30 subjects. After completion of the enrollment from Stage 2 and all subjects have completed at least two post baseline tumor evaluation, an interim analysis will be performed for efficacy evaluation. SMC will continuously review the safety and clinical efficacy during the study and at the interim analysis and be responsible for the decision of proceeding to Stage 3 (Biomarker enrich period).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KN046 monotherapy | Experimental | Drug: KN046Eligible subjects will be enrolled and receive KN046 monotherapy treatment until progressive disease according to RECIST 1.1, unacceptable toxicity, completion of 2 years' KN046 treatment, or withdrawal of informed consent, whichever comes first. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Signed informed consent form;
- 18 years of age or older, Male or female,
- Pathologically confirmed diagnosis of esophageal squamous cell carcinoma (ESCC)
- Had failed at front line regimen containing fluorouracil, paclitaxel and platinum. Disease progression within 6 months from previous adjuvant chemotherapy will be considered as failure of first line systemic therapy;
- Baseline measurable disease according to RECIST 1.1 from irradiated region or progressed within a previous radiation field;
Key exclusion criteria (8 listed)
- Untreated active CNS metastasis or leptomeningeal metastasis. Subjects may be eligible provided they are treated and clinically stable for at least 4 weeks and have no evidence of new or enlarging brain metastases and also are off steroids 7 days for treating brain metastasis prior to first trial treatment;
- Is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks prior to the first dose of trial treatment;
- Has received other anti-tumor treatment, including traditional Chinese medicine which has approved anti-tumor indication within 4 weeks prior to the first trial treatment;
- Major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment and/or if the subject has not fully recovered from the surgery within 4 weeks of the first administration of trial treatment;
- Curative radiation within 3 months of the first dose of trial treatment. Radiation to more than 30% of the bone marrow or with a wide field of radiation should not be used within 4 weeks prior to the first administration of trial treatment;
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 |
|---|---|---|
| KN046Eligible subjects will be enrolled and receive KN046 (3 mg/kg) monotherapy treatment until progressive disease according to RECIST 1.1, unacceptable toxicity, completion of 2 years' KN046 treatment, or withdrawal of informed consent, whichever comes first | Drug | KN046 monotherapy |
Primary outcome
Objective response (OR)
Time frame: up to 2 years
Objective response (OR) per RECIST 1.1 criteria according to investigators assessment;
Duration of response (DOR)
Time frame: up to 2 years
Duration of response (DOR) per RECIST 1.1 criteria according to investigators assessment;
3 secondary outcomes
Clinical benefit rate
Time frame: up to 2 years
Progression free survival (PFS) rates
Time frame: 6 months and 12 months
Overall survival (OS) rates
Time frame: 6 months and 12 months
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 5 Aug 2022.
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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 2 study testing KN046 in people with Esophageal Squamous Cell Carcinoma, run by Jiangsu Alphamab Biopharmaceuticals 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 11 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 5 Aug 2022. 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 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 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?
Objective response (OR) (time frame: up to 2 years). 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 Aug 2022.