Solid TumorPhase 2NCT04891198
ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors
A Phase 2 study testing Envafolimab in people with Solid Tumor, run by 3D Medicines (Sichuan) Co., Ltd. at 1 site in China.
Trial summary
An open, single-arm, multi-center Phase II clinical study of ENVAFOLIMAB single-agent treatment in patients with advanced solid tumors,to compare the overall response rate of TMB-high and TMB-Low,to determine the cut off value between TMB-high and TMB-Low of diagnosis device.Then,observe the efficacy of ENVAFOLIMAB… 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?
- Envafolimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteChina
- Study dates
- 6 Aug 2021to 30 Apr 2028
- 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
- Volunteer to participate and sign the informed consent form.
- Age ≥ 18 years old, regardless of gender.
- Patients with unresectable or metastatic advanced solid tumors confirmed by histology or cytology.
- Subjects with advanced malignant solid tumors who had disease progression or intolerance and no satisfactory alternative treatment with at least first-line standard treatment.
- Note: If recurrence occurs during adjuvant/neoadjuvant therapy or within 6 months after completion, adjuvant/neoadjuvant therapy is considered to be the first-line treatment for advanced disease.
- Have not received immune checkpoint inhibitor treatment.
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- Patients with the following tumor types: small cell lung cancer, cervical cancer, endometrial cancer, ovarian cancer, vulvar cancer, neuroendocrine tumors, salivary gland cancer, thyroid papillary or follicular cancer, skin squamous cell carcinoma, skin malignant melanoma , Merkel cell tumor, head and neck squamous cell carcinoma, colorectal cancer, gastric cancer, bladder cancer, cholangiocarcinoma, etc.
- Have tissue and blood samples that can detect TMB specimen.
- There is at least one measurable lesion (RECIST 1.1 standard).
- ECOG score of 0 or 1.
- The expected survival period is ≥ 12 weeks.
- Sufficient organ and bone marrow function (no hematopoietic growth factor, blood transfusion or platelet therapy was given within 7 days before the first study drug treatment):
- Blood routine: absolute neutrophil count (ANC) ≥1.5×109/L, platelet ≥100×109/L and hemoglobin ≥90 g/L;
- Liver function: serum total bilirubin ≤ 1.5 times the upper limit of the normal reference range (×ULN); when there is no liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; ALT and AST ≤5 × ULN in liver metastasis;
- Renal function: subjects with serum creatinine ≤ 1.5 × ULN or creatinine level> 1.5 times ULN, measured or calculated according to Cockcroft-Gault formula creatinine clearance rate ≥ 60.0 mL / min;
- Coagulation function: International normalized ratio (INR) ≤ 1.5 and partially activated prothrombin time (aPTT) ≤ 1.5 × ULN; (For patients undergoing anticoagulation therapy, the investigator judges that both INR and aPTT are safe and effective treatments Within);
- Heart function: left ventricular ejection fraction (LVEF) detected by echocardiography>50%
- Women with fertility must have a negative serum pregnancy test within 7 days before the first medication. Reproductive male or female patients voluntarily use effective contraceptive methods, such as double-barrier contraceptive methods, condoms, oral or injectable contraceptives, intrauterine devices, etc., from signing the informed consent until 90 days after the last study medication. All female patients will be considered fertile unless the female patient has been naturally menopausal, has undergone artificial menopause, or has been sterilized (such as hysterectomy, bilateral adnexectomy).
Who cannot join
- Participate in the clinical trials of other investigational drugs or investigational devices within 28 days before the first medication; or have received anti-tumor treatment within 2 weeks, including but not limited to chemotherapy and radiotherapy (allowed to complete the palliative at least 1 week before the study drug treatment Radiotherapy) or targeted therapy.
- The toxicity of previous anti-tumor treatments has not recovered to 0 or 1 level (hair loss, peripheral neurotoxicity caused by chemotherapy ≤ 2 can be selected). Subjects who need to use corticosteroids (> 10 mg/day prednisone equivalent dose) or other immunosuppressive drugs for systemic therapy within 14 days before the study drug is administered.
- Note: If there is no active autoimmune disease, inhaled or topical steroid hormones, or adrenal hormone replacement therapy with a prednisone equivalent dose of ≤ 10 mg per day is allowed. Allow short-term (≤ 7 days) use of glucocorticoids for preventive treatment (for example, for subjects with a history of severe allergies, when other anti-allergic drugs cannot be used instead to prevent allergy to contrast agents, researchers can use glucocorticoids according to local diagnosis and treatment routines Prevention) or for the treatment of non-autoimmune diseases (for example, delayed type hypersensitivity caused by contact allergens).
- Subjects who have active, or have had autoimmune diseases or risks that may recur (for example, an organ transplant that requires immunosuppressive therapy). However, subjects with type I diabetes, hypothyroidism requiring only hormone replacement therapy, or skin diseases that do not require systemic treatment (for example, vitiligo, psoriasis, or hair loss) are allowed to be included in the group. For any uncertain situation, it is recommended to consult the sponsor's medical monitor before signing the informed consent.
- Major surgery (except for biopsy) or the surgical incision did not heal completely within 4 weeks before the first study drug treatment.
- Suffered from other known malignant tumors within 2 years before enrollment (except for treated skin basal cell carcinoma, skin squamous cell carcinoma and/or carcinoma in situ after radical resection).
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- Untreated brain metastases and Symptomatic brain metastasis or spinal cord compression after treatment ; for patients with brain metastases who have previously received treatment, if the clinical and imaging evidence does not indicate disease progression within 4 weeks before the first study drug treatment, and 2 weeks before the first administration There is no need to receive corticosteroid treatment and can be considered for inclusion.
- Previous history of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia, symptomatic interstitial lung disease or any evidence of active pneumonia detected by chest CT scan within 4 weeks prior to first study drug therapy.
- Subjects with a history of active tuberculosis infection within 1 year before the first study administration and a history of active tuberculosis infection more than 1 year ago were considered suitable for inclusion if the investigator determined that there was no evidence of active tuberculosis at present.
- Mental or substance abuse disorders that are known to interfere with test compliance.
- A history of human immunodeficiency virus (HIV) infection or an active bacterial or fungal infection requiring systematic treatment in the 14 days prior to initial study drug therapy.
- Uncontrolled hepatitis virus infection (positive for HBV DNA or HCV RNA) .
- Within 4 weeks of initial administration, there is ascites requiring drainage or diuretic treatment, or pleural or pericardial effusion requiring drainage and/or symptoms of tachypnea.
- Cardiovascular disease with significant clinical significance.
- Receive live or attenuated live vaccine within 4 weeks prior to the first study drug treatment.
- History of severe allergic reaction to humanized antibodies or fusion proteins.
- Any other disease , and the investigator had reason to suspect that the patient was not eligible for study drug therapy.
- Part II: The results of tumor tissue samples were MSI-H
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
Lin Shen, MD, 86-010-88196340, doctorshenlin@sina.cn
About this study
Official title: An Open, Single-arm, Multi-center Phase II Clinical Study of ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors
An open, single-arm, multi-center Phase II clinical study of ENVAFOLIMAB single-agent treatment in patients with advanced solid tumors,to compare the overall response rate of TMB-high and TMB-Low,to determine the cut off value between TMB-high and TMB-Low of diagnosis device.Then,observe the efficacy of ENVAFOLIMAB uesd comfirmed TMB-H Value
Read the detailed description
The enrolled subjects will receive envafolimab treatment during the treatment phase, and the dosage and usage is 400 mg envafolimab subcutaneously injected every four weeks, 28 days as a treatment cycle.
The study treatment continued to reach the standard of stopping treatment. During this period, the efficacy, safety and PK will be evaluated according to the visit process.In this study, imaging examinations (CT or MRI) were used to evaluate the efficacy at baseline and during the study period. The results of the examination were evaluated based on the efficacy evaluation criteria for solid tumors (RECIST1.1) and irRECIST criteria.
- Conditions
- Solid Tumor
- Being tested
- Envafolimab
- Keywords
- TMB, solid tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnvafolimabDrug
Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Subjects with TMB-H/TMB-L | Experimental | Subjects receive KN035 400 mg Subcutaneously on Day 1 and day 15 of cycle 1 and on day 1 of every subsequent 4-week cycle (Q4W) Receives: Drug: Envafolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
To evaluate the objective response rate of Envafolimab in patients with advanced solid tumors with high tumor mutation burden (TMB-H) [Blind Independent Imaging Review Committee (BIRC) evaluation]
Measured: up to approximately half past one year
Secondary outcomes (5)
ORR
To evaluate the objective response rate of Envafolimab in patients with TMB-H and TMB-L advanced solid tumors (investigator assessment)
Measured: Up to approximately half past one year
DCR
To evaluate the disease control rateof Envafolimab in patients with TMB-H and TMB-L advanced solid tumors
Measured: Up to approximately half past one year
DoR
To evaluate the duration of remission of Envafolimab in patients with TMB-H and TMB-L advanced solid tumors
Measured: Up to approximately half past one year
PFS
To evaluate the progression-free survival of Envafolimab in patients with TMB-H and TMB-L advanced solid tumors
Measured: Up to approximately half past one year
OS
To evaluate the overall survival of Envafolimab in patients with TMB-H and TMB-L advanced solid tumors
Measured: Up to approximately half past one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start6 Aug 2021
- Primary completion30 Aug 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- 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
- Single group
- Model description
- This study is an open, single-arm study, without randomization and blinding
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 3D Medicines (Sichuan) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lin Shen, MD, Principal investigator, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891198
- Sponsor's protocol ID
- KN035-CN-012
- Status last verified
- Mar 2026
- First submitted
- 26 Apr 2021
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-arm, Multi-center Phase II Clinical Study of ENVAFOLIMAB Single-agent Treatment in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04891198
- Acronym / sponsor ID
- KN035-CN-012
- Conditions
- Solid Tumor
- Keywords
- TMB, solid tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- 3D Medicines (Sichuan) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2021 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 18 May 2021 (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.
An open, single-arm, multi-center Phase II clinical study of ENVAFOLIMAB single-agent treatment in patients with advanced solid tumors,to compare the overall response rate of TMB-high and TMB-Low,to determine the cut off value between TMB-high and TMB-Low of diagnosis device.Then,observe the efficacy of ENVAFOLIMAB uesd comfirmed TMB-H Value
Detailed description
The enrolled subjects will receive envafolimab treatment during the treatment phase, and the dosage and usage is 400 mg envafolimab subcutaneously injected every four weeks, 28 days as a treatment cycle.
The study treatment continued to reach the standard of stopping treatment. During this period, the efficacy, safety and PK will be evaluated according to the visit process.In this study, imaging examinations (CT or MRI) were used to evaluate the efficacy at baseline and during the study period. The results of the examination were evaluated based on the efficacy evaluation criteria for solid tumors (RECIST1.1) and irRECIST criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is an open, single-arm study, without randomization and blinding
| Arm | Type | Receives |
|---|---|---|
| Subjects with TMB-H/TMB-L | Experimental | Drug: EnvafolimabSubjects receive KN035 400 mg Subcutaneously on Day 1 and day 15 of cycle 1 and on day 1 of every subsequent 4-week cycle (Q4W) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Volunteer to participate and sign the informed consent form.
- Age ≥ 18 years old, regardless of gender.
- Patients with unresectable or metastatic advanced solid tumors confirmed by histology or cytology.
- Subjects with advanced malignant solid tumors who had disease progression or intolerance and no satisfactory alternative treatment with at least first-line standard treatment.
- Note: If recurrence occurs during adjuvant/neoadjuvant therapy or within 6 months after completion, adjuvant/neoadjuvant therapy is considered to be the first-line treatment for advanced disease.
Key exclusion criteria (18 listed)
- Participate in the clinical trials of other investigational drugs or investigational devices within 28 days before the first medication; or have received anti-tumor treatment within 2 weeks, including but not limited to chemotherapy and radiotherapy (allowed to complete the palliative at least 1 week before the study drug treatment Radiotherapy) or targeted therapy.
- The toxicity of previous anti-tumor treatments has not recovered to 0 or 1 level (hair loss, peripheral neurotoxicity caused by chemotherapy ≤ 2 can be selected). Subjects who need to use corticosteroids (> 10 mg/day prednisone equivalent dose) or other immunosuppressive drugs for systemic therapy within 14 days before the study drug is administered.
- Note: If there is no active autoimmune disease, inhaled or topical steroid hormones, or adrenal hormone replacement therapy with a prednisone equivalent dose of ≤ 10 mg per day is allowed. Allow short-term (≤ 7 days) use of glucocorticoids for preventive treatment (for example, for subjects with a history of severe allergies, when other anti-allergic drugs cannot be used instead to prevent allergy to contrast agents, researchers can use glucocorticoids according to local diagnosis and treatment routines Prevention) or for the treatment of non-autoimmune diseases (for example, delayed type hypersensitivity caused by contact allergens).
- Subjects who have active, or have had autoimmune diseases or risks that may recur (for example, an organ transplant that requires immunosuppressive therapy). However, subjects with type I diabetes, hypothyroidism requiring only hormone replacement therapy, or skin diseases that do not require systemic treatment (for example, vitiligo, psoriasis, or hair loss) are allowed to be included in the group. For any uncertain situation, it is recommended to consult the sponsor's medical monitor before signing the informed consent.
- Major surgery (except for biopsy) or the surgical incision did not heal completely within 4 weeks before the first study drug 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 |
|---|---|---|
| EnvafolimabSubcutaneous injection | Drug | Subjects with TMB-H/TMB-L |
Primary outcome
ORR
Time frame: up to approximately half past one year
To evaluate the objective response rate of Envafolimab in patients with advanced solid tumors with high tumor mutation burden (TMB-H) [Blind Independent Imaging Review Committee (BIRC) evaluation]
5 secondary outcomes
ORR
Time frame: Up to approximately half past one year
DCR
Time frame: Up to approximately half past one year
DoR
Time frame: Up to approximately half past one year
PFS
Time frame: Up to approximately half past one year
OS
Time frame: Up to approximately half past one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Lin Shen, MD principal investigator
Peking University Cancer Hospital & Institute
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 Envafolimab in people with Solid Tumor, run by 3D Medicines (Sichuan) 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 18 inclusion and 18 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: looking for participants now, as of the sponsor's last update on 25 Mar 2026. 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?
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?
Contact Lin Shen, MD (86-10-88196340, doctorshenlin@sina.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ORR (time frame: up to approximately half past one year). 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 25 Mar 2026.