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Solid TumorPhase 2NCT03667170

KN035 for dMMR/MSI-H Advanced Solid Tumors

A Phase 2 study testing KN035 in people with Solid Tumor, run by 3D Medicines (Sichuan) Co., Ltd. at 27 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

In this study, patients with previously-treated locally-advanced or metastatic mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) and other solid tumors will be treated with KN035 monotherapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
KN035
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
188 participants
Where
27 sitesChina
Study dates
22 Aug 2018to 30 Dec 2026
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Histologically confirmed locally advanced or metastatic colorectal carcinoma or other malignant solid tumors.
  • Confirmed MMR deficient or MSI-H status.
  • At least one measureable lesion.
  • Eastern Cooperative Oncology Group performance status of 0 or 1 .
  • Life expectancy of greater than 12 weeks.
  • Adequate hematologic and organ function.

Who cannot join

  • Currently participated in a study of an investigational agent and received trial treatment, or used an investigational device within 4 weeks of the first dose of medication in this study. Patients who have had specific anti-tumor treatment within 2 weeks prior to the first dose of study.
  • Patients who have not recovered to CTCAE Grade 1 or better from related side effects of any prior antineoplastic therapy.
  • Has received prior therapy with an immune check point agonist/inhibitor.
  • Patients who have undergone major surgery within 4 weeks of dosing of investigational agent.
  • Has a known additional malignancy that is progressing or requires active treatment within the past 5 years.
  • Known active central nervous system metastases and/or carcinomatous meningitis.
Show all 12Show fewer
  • Active autoimmune disease that has required systemic treatment.
  • Patients who have known history of infection with HIV.
  • Patients with evidence of interstitial lung disease.
  • Patients who have known history of any major cardiac abnormalities.
  • Patient who is not willing to apply highly effective contraception during the study.
  • Patients who have other concurrent severe and/or uncontrolled medical conditions that would, in the investigator's judgment, contraindicate patient participation in the clinical study.

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

China27 sites

  • Peking University Cancer Hospital, Peking University

    Beijing, Beijing Municipality, 100010

  • Peking University Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 10021

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Xiangya Hospital, Central South University

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Fujian Cancer Hospital

    Fuzhou, Fujian, 350014

  • The First Affiliated Hospital of Gannan Medical University

    Ganzhou, Jiangxi, 341000

  • The Sixth Affiliated Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510655

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 210022

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310009

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • The First Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230022

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • The First Affiliated Hospital of Henan University of Science and Technology

    Luoyang, Henan, 471003

  • Mianyang Central Hospital

    Mianyang, Sichuan, 621000

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi, 330006

  • Eastern Theater Command General Hospital (Qinhuai Medical District)

    Nanjing, Jiangsu, 210001

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

  • Jiangsu Province Hospital (The First Affiliated Hospital of Nanjing Medical University)

    Nanjing, Jiangsu, 210029

  • The Affiliated Tumor Hospital of Guangxi Medical University / Guangxi Cancer Hospital

    Nanning, Guangxi, 530022

  • The Second People's Hospital of Neijiang

    Neijiang, Sichuan, 641000

  • The Affiliated Hospital of Qingdao University (Shibei Campus)

    Qingdao, Shandong, 266000

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Zhongshan Hospital, Fudan University

    Shanghai, Shanghai Municipality, 200032

  • Union Hospital Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou, Henan, 450052

Other trials in China

About this study

Official title: Study of KN035 as Monotherapy in Patients With Advanced Mismatched Repair Deficient (dMMR) or Microsatellite Instability-High (MSI-H) Solid Tumors

In this study, patients with previously-treated locally-advanced or metastatic mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) and other solid tumors will be treated with KN035 monotherapy.

For colorectal cancer participants, who are required to have been previously treated with standard therapies , other solid tumor participants, who are required to have been previously treated with at least one line of systemic standard of care therapy.

Read the detailed description

Later-line therapies after failure of standard treatments for advanced colorectal and non-colorectal cancer patients are limited. Mismatch repair (MMR) deficiency or microsatellite instability-high (MSI-H) played a role of positive predictive factor, which had been documented after the pembrolizumab and nivolumab trial were reported, for PD-1 blockade monotherapy in patients with advanced colorectal and non-colorectal cancers.

In this study, patients with previously-treated locally-advanced or metastatic mismatched repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal carcinoma (CRC) and other solid tumors will be treated with KN035 monotherapy.

For colorectal cancer participants, who are required to have been previously treated with standard therapies. For other solid tumor participants, who are required to have been previously treated with at least one line of systemic standard of care therapy.

Conditions
Solid Tumor
Being tested
KN035
Keywords
MSI-H, dMMR, Colorectal cancer, Non-Colorectal Cancers
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KN035Biological

    subcutaneous injection

Study groups in NCT03667170
Study groupRoleWhat they receive
Subjects with MSI-H/dMMRExperimentalpatients receive 600 mg of the KN035 Subcutaneously every 3 weeks
Receives: Biological: KN035

What is being measured

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

  1. Objective Response Rate (ORR)

    per Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST 1.1) assessed by central imaging vendor

    Measured: Up to approximately 2 years

Secondary outcomes (9)

  1. ORR

    per Response Evaluation Criteria in Solid Tumors v 1.1 (RECIST 1.1) assessed by investigator

    Measured: Up to approximately 2 years

  2. Disease Control Rate (DCR)

    per RECIST 1.1 assessed by central imaging vendor and investigator

    Measured: Up to approximately 2 years

  3. Duration of Response (DOR)

    per RECIST 1.1 assessed by central imaging vendor and investigator

    Measured: Up to approximately 2 years

  4. Progression-Free Survival (PFS)

    per RECIST 1.1 assessed by central imaging vedor and investigator

    Measured: Up to approximately 2 years

  5. Overall Survival (OS)

    Calculated by the Kaplan-Meier method.

    Measured: Up to approximately 2 years

  6. Assessment of the safety of KN035 as monotherapy in patients with advanced dMMR/MSI-H solid tumors.

    Safety of KN035 will be evaluated based on the incidence and severity of adverse events, which will be graded according to NCI CTCAE Version 4.03.

    Measured: Up to approximately 2 years

  7. Assessment of the tolerability of KN035 as monotherapy in patients with advanced dMMR/MSI-H solid tumors.

    Tolerability of KN035 will be evaluated based on the incidence and severity of adverse events, which will be graded according to NCI CTCAE Version 4.03.

    Measured: Up to approximately 2 years

  8. Plasma Concentration of KN035

    Plasma concentration of KN035 at specified time points after administration, measured using a validated bioanalytical assay.

    Measured: Up to approximately 2 years

  9. Anti-Drug Antibody (ADA) against KN035

    Detection of anti-drug antibody (ADA) against KN035 in subject serum samples using a validated ADA immunoassay.

    Measured: Up to approximately 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2018
  2. Study start22 Aug 2018
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion30 Dec 2026 (estimated)

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
Single group
Masking
None (open label)
Enrolment
188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03667170
Sponsor's protocol ID
KN035-CN-006
Status last verified
Sep 2026
First submitted
10 Sep 2018
Last updated
19 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cui C, Wang J, Wang C, Xu T, Qin L, Xiao S, Gong J, Song L, Liu D. Model-informed drug development of envafolimab, a subcutaneously injectable PD-L1 antibody, in patients with advanced solid tumors. Oncologist. 2024 Sep 6;29(9):e1189-e1200. doi: 10.1093/oncolo/oyae102.

    PubMed 38982653

  • Li J, Deng Y, Zhang W, Zhou AP, Guo W, Yang J, Yuan Y, Zhu L, Qin S, Xiang S, Lu H, Gong J, Xu T, Liu D, Shen L. Subcutaneous envafolimab monotherapy in patients with advanced defective mismatch repair/microsatellite instability high solid tumors. J Hematol Oncol. 2021 Jun 21;14(1):95. doi: 10.1186/s13045-021-01095-1.

    PubMed 34154614

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing KN035 in people with Solid Tumor, run by 3D Medicines (Sichuan) Co., Ltd. at 27 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 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: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 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 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?

This study is still under way. Results are not available in the source record yet.

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: Up to approximately 2 years). 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 NCT03667170, 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 19 Oct 2026.

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