Advanced Solid TumorsPhase 1NCT03733951
KN046 in Subjects With Advanced Solid Tumors and Lymphoma
A Phase 1 study testing KN046 in people with Advanced Solid Tumors and Lymphoma, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 13 sites in China.
Trial summary
This is a phase Ia/Ib, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN046 in subjects with advanced solid tumors and lymphoma . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Lymphoma
- What is being tested?
- KN046
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 13 sitesChina
- Study dates
- 18 Dec 2018to 2 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent; willing and able to complete all required procedures of study.
- With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected.
- Subjects must have at least one measurable lesion in advanced solid tumors, at least one measurable or assessable lesion in NK/T cell lymphoma.
- ECOG performance status of 0 or 1.
- Subject must have adequate organ function.
- Female patients and males with partners of childbearing potential should be using highly effective contraceptive measures (failure rate of less than 1% per year). Contraception should be continued for a period of 24 weeks after dosing has been completed.
- Ability to comply with treatment, procedures and PK sample collection and the required study follow-up procedures.
Who cannot join
- Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
- Is currently participating or has participated in a study of an investigational drug within 4 weeks prior to the first dose of trial treatment.
- Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
- Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
- Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
- Active HBV or HCV infection.
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- Known HIV infection or known history of acquired immune deficient syndrome (AIDS).
- Any unresolved CTCAE Grade ≥ 2 toxicities from prior anti-cancer therapy with the exception of vitiligo, alopecia.
- Patients who have serious hypersensitive reaction to monoclonal antibodies, and have history of uncontrolled allergic asthma.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
China13 sites
Chengdu Seventh People's Hospital
Chengdu, Sichuan
Fujian Cancer Hospital
Fuzhou, Fujian
Fujian Medical University Union Hospital
Fuzhou, Fujian
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Zhejiang Cancer Hospital
Hangzhou, Zhejiang
LINYI Cancer Hospital
Linyi, Shandong
Shanghai East Hospital
Shanghai, Shanghai Municipality
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian
Henan Cancer Hospital
Zhengzhou, Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: An Open-Label, Multicenter, Dose-Escalation and Expansion Phase Ia/Ib Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of KN046 Monotherapy in Subjects With Advanced Solid Tumors and Lymphoma
This is a phase Ia/Ib, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN046 in subjects with advanced solid tumors and lymphoma .
- Conditions
- Advanced Solid Tumors, Lymphoma
- Being tested
- KN046
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN046Drug
Phase Ia：Intravenous (IV) infusions, 1,3 and 5 milligrams per kilogram (mg/kg) every 2 weeks.
Phase Ib：Intravenous (IV) infusions, 1 ,3 or 3, 5 milligrams per kilogram (mg/kg) every 2 weeks, the dose of phase Ib based on the result of phase Ia.
| Study group | Role | What they receive |
|---|---|---|
| KN046 | Experimental | Not described Receives: Drug: KN046 |
What is being measured
The primary outcome is the main question the study is designed to answer.
In the dose escalation part, number of participants with dose limiting toxicity (DLT).
Measured: During the first 4 weeks of treatment.
In the dose expansion part,Objective response rate (ORR).
Objective response is defined as complete response (CR) or partial response (PR)
Measured: up to 2 years.
In the dose expansion part, Duration of response (DoR).
Duration of response is defined as the time period from the date of initial independent review committee assessed CR or PR until the date of PD or death from any cause, whichever occurs first.
Measured: up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2018
- Study start18 Dec 2018
- Primary completion3 Jan 2023
- Study completion2 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 139 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
- NCT03733951
- Sponsor's protocol ID
- KN046-CHN-001
- Status last verified
- Jun 2023
- First submitted
- 31 Oct 2018
- Last updated
- 9 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ma Y, Xue J, Zhao Y, Zhang Y, Huang Y, Yang Y, Fang W, Guo Y, Li Q, Ge X, Sun J, Zhang B, Zhang Y, Xiao J, Zhang L, Zhao H. Phase I trial of KN046, a novel bispecific antibody targeting PD-L1 and CTLA-4 in patients with advanced solid tumors. J Immunother Cancer. 2023 Jun;11(6):e006654. doi: 10.1136/jitc-2022-006654.
PubMed 37263673
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multicenter, Dose-Escalation and Expansion Phase Ia/Ib Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of KN046 Monotherapy in Subjects With Advanced Solid Tumors and Lymphoma
- ClinicalTrials.gov ID
- NCT03733951
- Acronym / sponsor ID
- KN046-CHN-001
- Conditions
- Advanced Solid Tumors, Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Jiangsu Alphamab Biopharmaceuticals Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2018 (actual)
- Primary completion
- 3 Jan 2023 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 7 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.
This is a phase Ia/Ib, open-label, multicenter, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN046 in subjects with advanced solid tumors and lymphoma .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KN046 | Experimental | Drug: KN046 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Signed informed consent; willing and able to complete all required procedures of study.
- With advanced-stage or metastatic tumor (unresectable) and experienced progression since last anti-tumor treatment; standard therapy is not available or rejected.
- Subjects must have at least one measurable lesion in advanced solid tumors, at least one measurable or assessable lesion in NK/T cell lymphoma.
- ECOG performance status of 0 or 1.
- Subject must have adequate organ function.
Key exclusion criteria (9 listed)
- Known brain metastasis or other CNS metastasis that is either symptomatic or untreated.
- Is currently participating or has participated in a study of an investigational drug within 4 weeks prior to the first dose of trial treatment.
- Patients who have received immune checkpoint proteins/antibody/medicine (including PD-1, PD-L1, etc) for treatment.
- Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management.
- Subjects with active autoimmune diseases or history of autoimmune diseases should be excluded.
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 |
|---|---|---|
| KN046Phase Ia：Intravenous (IV) infusions, 1,3 and 5 milligrams per kilogram (mg/kg) every 2 weeks. Phase Ib：Intravenous (IV) infusions, 1 ,3 or 3, 5 milligrams per kilogram (mg/kg) every 2 weeks, the dose of phase Ib based on the result of phase Ia. | Drug | KN046 |
Primary outcome
In the dose escalation part, number of participants with dose limiting toxicity (DLT).
Time frame: During the first 4 weeks of treatment.
In the dose expansion part,Objective response rate (ORR).
Time frame: up to 2 years.
Objective response is defined as complete response (CR) or partial response (PR)
In the dose expansion part, Duration of response (DoR).
Time frame: up to 2 years.
Duration of response is defined as the time period from the date of initial independent review committee assessed CR or PR until the date of PD or death from any cause, whichever occurs first.
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 9 Jun 2023.
- Derived from this study: PubMed 37263673Ma Y, Xue J, Zhao Y, Zhang Y, Huang Y, Yang Y, Fang W, Guo Y, Li Q, Ge X, Sun J, Zhang B, Zhang Y, Xiao J, Zhang L, Zhao H. Phase I trial of KN046, a novel bispecific antibody targeting PD-L1 and CTLA-4 in patients with advanced solid tumors. J Immunother Cancer. 2023 Jun;11(6):e006654. doi: 10.1136/jitc-2022-006654.
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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.
13 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 KN046 in people with Advanced Solid Tumors and Lymphoma, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 13 sites 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 7 inclusion and 9 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 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites 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?
In the dose escalation part, number of participants with dose limiting toxicity (DLT). (time frame: During the first 4 weeks of treatment.). 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?
On the ClinicalTrials.gov record for NCT03733951, which also lists 1 linked publication.
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 9 Jun 2023.