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HER2-positive Solid TumorsPhase 2NCT04521179

Study of KN026 Combined With KN046 in Patients With Locally Advanced HER2-positive Solid Tumors

A Phase 2 study testing KN026 combination in people with HER2-positive Solid Tumors, run by Jiangsu Alphamab Biopharmaceuticals Co., Ltd at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an open-label, phase II，multi-center study to evaluate the efficacy, safety and tolerability of KN026 in combination with KN046 in subjects with 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 Tumors
What is being tested?
KN026 combination
Could I receive a placebo?
No, everyone receives an active treatment
How many people
102 participants
Where
1 siteChina
Study dates
7 Dec 2020to 22 May 2023
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

  • The subject can understand the informed consent, voluntarily participate and sign the informed consent ;
  • Subjects are older than or equal to 18 years old and younger than or equal to 75 years old on the day of signing the informed consent；
  • Histologically or cytologically confirmed, metastatic or locally advanced unresectable HER2-positive solid tumors;
  • Prior antitumor therapy needs to meet the following conditions:
  • Her2-positive GC/GEJ: has not received prior systemic treatment for metastatic or locally advanced unresectable GC/GEJ, or has received prior systemic treatment≥1 line of systemic treatment with disease progression, front-line systemic treatment includes at least platinum or fluorouracil based chemotherapy with or without trastuzumab; Subjects who relapsed within 6 months after the end of neoadjuvant/adjuvant chemotherapy were considered as line 1 treatment failure; Her2-positive BC: prior treatment with ≥1 line of HER2-targeted therapy for metastatic disease and disease progression; Subjects who relapsed within 12 months after the end of neoadjuvant/adjuvant chemotherapy were considered as line 1 treatment failure; Other HER2-positive solid tumors: previous ≥1 line of systemic therapy for metastatic or locally advanced unresectable tumors with disease progression, no clear standard therapy for prolongation of survival, or after subjects rejected 1 line of systemic therapy; Frontline systemic therapy for ovarian and cervical cancer includes at least platinum-based (cisplatin or carboplatin) chemotherapy; Frontline systemic therapy for ESCC and mCRC includes at least platinum combined with fluorouracil or tax-based chemotherapy; MCRC requires ≥2 lines of systemic therapy for metastatic or locally advanced unresectable tumors and disease progression; Subjects who relapsed within 6 months after completion of neoadjuvant/adjuvant platinum-containing chemotherapy Line 1 treatment failure;
  • At least 1 measurable lesion at baseline according to RECIST1.1 criteria；
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  • ECOG score 0 or 1;
  • Left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either ECHO (preferred) or MUGA;
  • Liver function met the following criteria within 7 days prior to initial administration:
  • Total bilirubin ≤1.0x ULN (Gilbert's syndrome, or total bilirubin ≤1.5x ULN in liver metastases); Aminotransferase (ALT/AST) ≤1.5x ULN (liver metastatic subjects ≤3xULN); -Renal function within 7 days prior to initial administration: serum creatinine ≤1.5x ULN and serum creatinine clearance ≥60mL/min (according to Cockcroft-Gault Formula calculation);
  • -Bone marrow function met the following criteria within 7 days prior to initial administration: Hemoglobin ≥90 g/L; Neutrophil absolute count ≥1.5 x 109/L; Platelet count ≥100x 109/L; INR or PT≤1.5x ULN, and aPTT≤ 1.5x ULN;
  • TSH normal range： If TSH is abnormal, total or free T3 and free T4 should be in the normal range
  • Life expectancy >3 months;
  • Fertile female subjects or fertile male subjects with a partner agreed to use hepa beginning 7 days prior to the first dose pregnancy continued until 24 weeks after drug withdrawal. Fertile female subjects must have a negative serum pregnancy test within 7 days prior to first dosing;
  • The subjects are able and willing to follow the visits, treatment plans, laboratory tests, and other study-related procedures specified in the study protocol

Who cannot join

  • Untreated active brain metastasis or leptomeningeal metastasis;
  • Historyof Left ventricular ejection fraction (LVEF) decline to < 45% or absolute decrease for > 15% during the treatment course from prior HER2-targeted therapy;
  • Previous cumulative doses of anthracycline exceeded doxorubicin or liposomal doxorubicin >320mg/m2 or equivalent doses of other anthracyclines;
  • Has received other anti-tumor treatment or an investigational drug within 28 days or 5 half-lives prior(whichever is shorter, but at least 2 weeks) to the first trial treatment;
  • Major surgery (transabdominal, transthoracic, etc.) within 28 days prior to initial administration; Diagnostic puncture or peripheral vascular is not included pathway replacement)
  • Radical radiotherapy within 3 months prior to initial administration; Palliative radiotherapy is allowed 2 weeks before administration, and the dose of radiotherapy is in line with local palliative the diagnosis and treatment standard of sexual therapy and the coverage of radiotherapy is less than 30% of the bone marrow region;
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  • Prior treatment with immune checkpoint blockers or T cell costimulators;
  • Systemic corticosteroid or immunosuppressant therapy is required for 7 consecutive days within 14 days of initial dosing
  • Received live vaccines (including attenuated live vaccines) within 28 days of initial administration;
  • Have interstitial lung disease or a history of non-infectious pneumonia requiring oral or intravenous glucocorticoid treatment;
  • Have a past or current autoimmune disease;
  • Other malignant tumors occurred within 5 years prior to initial administration;
  • With uncontrolled comorbidities;
  • Toxicity from previous antitumor therapy did not return to CTCAE grade ≤1 (NCI-CTCAEV 5.0) or baseline levels;
  • Prior allo-HSCT or solid organ transplant;
  • History of allergic reaction, hypersensitivity reaction and intolerance to antibody drugs; Prior allergic reaction to medication ;
  • Pregnant or nursing females;
  • Other medical conditions that at the discretion of investigator interfere with the requirements of the trial in terms of safety or efficacy evaluation, or treatment compliance;
  • BMI less than 18.5kg/m2 or weight loss ≥10% within 2 months prior to screening.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

Other trials in China

About this study

Official title: A Phase II, Open-Label, Multi-Center Study to Evaluate Efficacy, Safety and Tolerability of KN026 in Combination With KN046 in Patients With Locally Advanced Unresectable or Metastatic HER2-positive Solid Tumors

This is an open-label, phase II，multi-center study to evaluate the efficacy, safety and tolerability of KN026 in combination with KN046 in subjects with HER2-positive solid tumors.

Read the detailed description

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. The study composes of two stages. The first stage plans to enroll HER2-positive solid tumors. All subjects will be treated with KN026 at 30 mg/kg Q3W in combination with KN046 at 5 mg/kg Q3W at the first stage.A SMC meeting will decide whether to proceed to the nest stage.

Being tested
KN026 combination
Keywords
KN026 and 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 combinationDrug

    Also called IO therapy

    30 mg/kg Q3W KN026+ 5 mg/kg Q3W KN046

Study groups in NCT04521179
Study groupRoleWhat they receive
KN026 combined with KN046ExperimentalKN026 combination therapy
Receives: Drug: KN026 combination

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective response rate (ORR )

    Objective response rate as assessed by the investigator according to RECIST 1.1 criteria

    Measured: Throughout the duration of the study; up to 2 years

  2. Duration of response (DOR)

    Duration of response (DOR) as assessed by the investigator according to RECIST 1.1 criteria

    Measured: Throughout the duration of the study; up to 2 years

Secondary outcomes (3)

  1. Progression free survival (PFS) rates

    Progression free survival (PFS) rates

    Measured: 6 months and 12 months

  2. Clinical benefit rate (CBR)

    Clinical benefit rate

    Measured: CBR calculated as the proportion of subjects with best overall response of CR, PR, or SD ≥24 weeks

  3. Overall survival (OS)

    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.

  1. First posted20 Aug 2020
  2. Study start7 Dec 2020
  3. Primary completion12 Jan 2022
  4. Study completion22 May 2023

Resources

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
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04521179
Sponsor's protocol ID
KN026-203
Status last verified
May 2023
First submitted
18 Aug 2020
Last updated
21 Sep 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Liao JY, Wang J, Li H, Liu Z, Tian Z, Lv X, Peng J, Song C, Liu J. Longitudinal tissue analysis reveals microenvironmental changes correlate with combined immunotherapy and targeted therapy response in metastatic breast cancer. J Immunother Cancer. 2025 Oct 5;13(10):e012629. doi: 10.1136/jitc-2025-012629.

    PubMed 41052881

  • 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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KN026 combination in people with HER2-positive Solid Tumors, 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 15 inclusion and 19 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 21 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 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 rate (ORR ) (time frame: Throughout the duration of the study; 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?

On the ClinicalTrials.gov record for NCT04521179, which also lists 2 linked publications.

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 21 Sep 2023.

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