HER2 Positive Solid TumorPhase 1NCT04040699
KN026 Combined With KN046 in Subjects With HER2 Positive Solid Tumor
A Phase 1 study testing KN026 combined with KN046 in people with HER2 Positive Solid Tumor, run by Peking University at 1 site in China.
Trial summary
This is a phase Ib, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN026 combined with KN046 in subjects with advanced HER2 positive solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HER2 Positive Solid Tumor
- What is being tested?
- KN026 combined with KN046
- 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
- 26 Sep 2019to 1 Dec 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed inform consent form (ICF)
- Age ≥ 18 years and ≤ 75 years, male or female
- Histologically or cytologically documented advanced HER2 positive solid tumor
- Received at least one prior standard therapy
- At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
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- Adequate organ function
- LVEF≥ 50% (ECHO)
- 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 pharmacokinetics (PK) sample collection and the required study follow-up procedures
Who cannot join
- Accepted any other anti-tumor drug therapies within 4 weeks before fist dose
- Accepted radiotherapy within 4 weeks before enrollment
- An anthracyclines antibiotic treatment was received exceeding 320 mg/m² or other equivalent dose antharcyclines
- Subjects are eligible with clinically controlled and stable neurologic function >= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible
- 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)
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- Pregnant or nursing females；or intend pregnancy within this study period or within 6 monthes after the end of this study
- Severe chronic and active infection, need to system antibiosis/antiviral treatment
- Has interstitial lung disease, or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with management
- Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled, and need locally treatment or repeated drainage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase Ib Study to Evaluate Efficacy, Safety and Tolerability of KN026 Combined With KN046 in Subjects With HER2 Positive Solid Tumor
This is a phase Ib, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN026 combined with KN046 in subjects with advanced HER2 positive solid tumors.
Read the detailed description
The study is composed of 2 stages. Stage 1 consists of dose escalation cohorts for determining the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Part 2 consists of 4 tumor type expansion cohorts for expanding the information on clinical safety, clinical pharmacokinetics and antitumor activity in HER2 positive patients.
- Conditions
- HER2 Positive Solid Tumor
- Being tested
- KN026 combined with KN046
- Keywords
- KN026, KN046, HER2 Positive Solid Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KN026 combined with KN046Biological
KN026 and KN046 are given at 20mg/Kg and 3mg/Kg intravenously on day 1of each 2 weeks cycle at the beginning respectively.The dosage will be escalated if adverse events are tolerated according to the scheme.
| Study group | Role | What they receive |
|---|---|---|
| KN026 combined with KN046 | Experimental | KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade.
KN046 is a PD-L1 - CTLA-4 bispecific antibody. Receives: Biological: KN026 combined with KN046 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity（DLT）
Dose-limiting toxicity
Measured: 28 days
Objective response rate (ORR)
Objective response rate (ORR) 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 posted1 Aug 2019
- Study start26 Sep 2019
- Primary completion22 Sep 2022
- Study completion1 Dec 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 HER2 Positive Solid TumorStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Responsible party
- Principal investigator, Shen Lin, Peking University
- Investigators
- Lin Shen, MD,PhD, Principal investigator, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04040699
- Sponsor's protocol ID
- KN046-IST-02
- Status last verified
- Apr 2024
- First submitted
- 30 Jul 2019
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu D, Gong J, Li J, Qi C, Niu Z, Liu B, Peng Z, Luo S, Wang X, Wang Y, Zhao R, Chen L, Deng T, Li Z, Chen L, Fang M, Yang H, Lu L, Zhang Y, Kang F, Xu T, Zhang X, Shen L. Efficacy and safety of KN026, a bispecific anti-HER2 antibody, in combination with KN046, an anti-CTLA4/PD-L1 antibody, in patients with advanced HER2-positive nonbreast cancer: a combined analysis of a phase Ib and a phase II study. Signal Transduct Target Ther. 2025 Mar 19;10(1):104. doi: 10.1038/s41392-025-02195-x.
PubMed 40108113
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Study to Evaluate Efficacy, Safety and Tolerability of KN026 Combined With KN046 in Subjects With HER2 Positive Solid Tumor
- ClinicalTrials.gov ID
- NCT04040699
- Acronym / sponsor ID
- KN046-IST-02
- Conditions
- HER2 Positive Solid Tumor
- Keywords
- KN026, KN046, HER2 Positive Solid Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Jiangsu Alphamab Biopharmaceuticals Co., Ltd
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 22 Sep 2022 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 1 Aug 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 Ib, open-label, dose-escalation and expansion study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of KN026 combined with KN046 in subjects with advanced HER2 positive solid tumors.
Detailed description
The study is composed of 2 stages. Stage 1 consists of dose escalation cohorts for determining the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D). Part 2 consists of 4 tumor type expansion cohorts for expanding the information on clinical safety, clinical pharmacokinetics and antitumor activity in HER2 positive patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| KN026 combined with KN046 | Experimental | Biological: KN026 combined with KN046KN026 is an anti-HER2 bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, leading to a dual HER2 signal blockade. KN046 is a PD-L1 - CTLA-4 bispecific antibody. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed inform consent form (ICF)
- Age ≥ 18 years and ≤ 75 years, male or female
- Histologically or cytologically documented advanced HER2 positive solid tumor
- Received at least one prior standard therapy
- At least one measurable lesion according to Response Evaluation Criteria In Solid Tumors（RECISIT） v 1.1
Key exclusion criteria (10 listed)
- Accepted any other anti-tumor drug therapies within 4 weeks before fist dose
- Accepted radiotherapy within 4 weeks before enrollment
- An anthracyclines antibiotic treatment was received exceeding 320 mg/m² or other equivalent dose antharcyclines
- Subjects are eligible with clinically controlled and stable neurologic function >= 4 weeks, which is no evidence of CNS disease progression; Subjects with spinal cord compression and cancerous meningitis are not eligible
- 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)
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 |
|---|---|---|
| KN026 combined with KN046KN026 and KN046 are given at 20mg/Kg and 3mg/Kg intravenously on day 1of each 2 weeks cycle at the beginning respectively.The dosage will be escalated if adverse events are tolerated according to the scheme. | Biological | KN026 combined with KN046 |
Primary outcome
Dose-limiting toxicity（DLT）
Time frame: 28 days
Dose-limiting toxicity
Objective response rate (ORR)
Time frame: up to 2 years
Objective response rate (ORR) 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 9 Apr 2024.
- Derived from this study: PubMed 40108113Liu D, Gong J, Li J, Qi C, Niu Z, Liu B, Peng Z, Luo S, Wang X, Wang Y, Zhao R, Chen L, Deng T, Li Z, Chen L, Fang M, Yang H, Lu L, Zhang Y, Kang F, Xu T, Zhang X, Shen L. Efficacy and safety of KN026, a bispecific anti-HER2 antibody, in combination with KN046, an anti-CTLA4/PD-L1 antibody, in patients with advanced HER2-positive nonbreast cancer: a combined analysis of a phase Ib and a phase II study. Signal Transduct Target Ther. 2025 Mar 19;10(1):104. doi: 10.1038/s41392-025-02195-x.
- 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.
Lin Shen, MD,PhD principal investigator
Peking University
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 KN026 combined with KN046 in people with HER2 Positive Solid Tumor, run by Peking University 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 10 inclusion and 10 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 Apr 2024. 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?
Dose-limiting toxicity（DLT） (time frame: 28 days). 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 NCT04040699, 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 Apr 2024.