A Multicenter, Open-label, Phase II Clinical Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics (PK), and Immunogenicity of the Combination Therapy of SYS6026 in the Treatment of Advanced Solid Tumors

An observational study of Solid Tumor, run by CSPC Megalith Biopharmaceutical Co.,Ltd..

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Trial summary

This trial is a multicenter, open-label, dose exploration and cohort expansion Phase II clinical study designed to evaluate the safety, immunogenicity, and preliminary efficacy of different dosing regimens of SYS6026 injection (hereinafter referred to as "SYS6026") combined with Enlonstobart in patients with… 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?: SYS6026 combined with Enlonstobart therapy
How many people: 186 participants
Where: No sites listed yet
Study dates: 20 Jul 2026to 31 Dec 2029
Phase: Observational
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

Study population: participate advanced solid tumors

Who may be able to join

Age ≥18 years;
Confirmation by the research center of HPV type 16 and/or 18 infection in tumor tissue;
Pathologically confirmed unresectable locally advanced or metastatic solid tumor;
ECOG PS score of 0-1;
Estimated survival of at least 3 months;
Normal function of major organs within 1 week prior to the initial vaccination/randomization (no administration of erythrocyte transfusion or hematopoietic stimulation factors [e.g., granulocyte colony-stimulating factor, erythropoietin, thrombopoietin] within 14 days before screening, and no platelet transfusion within 7 days before screening):

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ANC≥1.5×109/L；
PLT≥100×109/L；
Hb≥90 g/L；
TBIL≤1.5×ULN，Participants with Gilbert syndrome
TBIL≤3×ULN；
ALT和AST≤2.5×ULN；
Cr≤1.5×ULN，or creatinine clearance≥45 mL/min（Cockcroft-Gault）；
APTT≤1.5×ULN，PT≤1.5×ULN，INR≤1.5×ULN。
Eligible participants of reproductive age (both males and females) must agree to use reliable contraceptive methods (hormonal contraceptives, barrier methods, or abstinence) with their partner from the date of signing the informed consent form until 6 months after the last dose administration.
Applicable only during the combination dose exploration phase:
patients in advanced stages who have failed standard treatment (including disease progression or intolerance to standard therapy) and lack effective therapeutic options; where intolerance to standard therapy refers to permanent discontinuation of previous standard treatment requiring switching to alternative regimens; and meeting RECIST 1.1 criteria with at least one evaluable lesion.
According to RECIST 1.1, there must be at least one evaluable lesion;
Applicable only to the queue expansion phase:
Enrollment during the queue expansion phase:
Cluster 1: Advanced recurrent or metastatic cervical cancer that has failed at least one line of standard therapy;
Cluster 2: Irresectable locally advanced or metastatic solid tumors (including anal, vulvar, vaginal, oropharyngeal, oral, laryngeal, and penile cancers) that have failed first-line standard therapy;
Cluster 3 (randomized controlled cohort for first-line maintenance therapy in cervical cancer): PD-L1-positive advanced recurrent or metastatic cervical cancer patients who received platinum-based chemotherapy plus encetuximab/PD-(L)1 inhibitor ± bevacizumab for ≤6 cycles without progression, with the last antitumor treatment administered no later than 6 weeks prior to randomization.
Adequate tumor specimens can be provided for biomarker testing;
according to RECIST 1.1, there must be at least one measurable lesion (cohorts 1 and 2).

Who cannot join

Tumor tissue testing reveals co-infection with other high-risk HPV types;
Presence of two primary tumors (applicable only to Cohort 3); for patients not in Cohort 3, inclusion is permitted if they have two primary cancers that are unsuitable for surgery, have failed standard treatment, and are considered by investigators to benefit from this study;
Adverse reactions from prior antitumor therapy have not yet resolved to CTCAE Grade V5.0 level ≤1 (excluding alopecia or participants deemed clinically insignificant by investigators);
Participation in other clinical trials involving the study drug within 28 days prior to first administration/randomization, excluding observational (non-interventional) trials or follow-up phases of intervention trials;
Previous long-term (≥7 days) systemic use of immunosuppressants or initial systemic immunosuppressive therapy within 14 days prior to first administration/randomization;
Patients who have received whole blood, plasma, or immunoglobulin therapy within the past 1 month; those with clinically diagnosed known immunological dysfunction or impairment; or individuals with functional splenectomy or complete splenectomy due to any medical condition..

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First administration of the vaccine/within 28 days prior to randomization, or planned administration of an attenuated live vaccine during the study period.
During the screening period, patients exhibited systemic active infections (defined as requiring intravenous administration of antibacterial, antifungal, or antiviral medications)..
Has a severe history of cardiovascular and cerebrovascular diseases, including but not limited to:
.Heart failure classified as grade ≥2 according to the NYHA classification;
first-time medication use or occurrence of myocardial infarction, treatment-needed arrhythmia, or unstable angina within 6 months prior to randomization;
first-time medication use or occurrence of arterial/venous thrombosis or embolism (e.g., transient ischemic attack, cerebral hemorrhage, cerebral infarction [including lacunar infarction], deep vein thrombosis, or pulmonary embolism) within 6 months prior to randomization;
QTcF> 450 ms;
poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg and/or diastolic blood pressure ≥ 90 mmHg during screening), with a history of hypertensive crisis or hypertensive encephalopathy.
Patients with active autoimmune diseases or a history of autoimmune disorders (e.g., myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, pituititis, uveitis, etc.) are eligible. Eligible conditions include well-controlled type 1 diabetes mellitus; hypothyroidism requiring only hormone replacement therapy and well-controlled; skin diseases (e.g., vitiligo, psoriasis, alopecia) not requiring systemic treatment; or participants with a predicted low risk of disease recurrence in the absence of external triggers..
Active hepatitis B (HBsAg-positive with HBV DNA ≥ 500 IU/mL or ≥ 2,500 copies/mL) or hepatitis C (HCV antibody-positive with HCV-RNA quantification ≥ the lower limit of the detection range) (Note: For HBsAg-positive patients, antiviral therapy is recommended prior to initial use of the study drug; nucleoside analogs such as entecavir or tenofovir disoproxil are preferred); co-infection with both HBV and HCV (HBsAg-positive and HCV antibody-positive) is not eligible for enrollment..
History of immunodeficiency or positive HIV antibody test;
Fever (axillary temperature ≥38.0°C) within 3 days prior to the first dose of the trial vaccine, acute illness within the previous 5 days, or acute exacerbation of a chronic condition; or use of antipyretics, analgesics, or anti-allergic medications within 3 days before the first vaccine dose;
Interstitial lung disease with accompanying symptoms/signs during screening (excluding radiation-induced localized interstitial pneumonia), non-infectious pneumonia requiring glucocorticoid therapy; history of specific pulmonary fibrosis, drug-induced pneumonia, specific pneumonia, or organized pneumonia (e.g., obstructive bronchiolitis, cryptogenic organized pneumonia);
Pregnant or breastfeeding women;
Known or suspected allergy to the trial drug or its components, severe allergy history, history of allergic diseases, or allergic predisposition;
Other circumstances that may interfere with participant compliance with the study protocol, compromise maximum benefit from participation, or affect study outcomes.

About this study

Read the detailed description

(Limit: 32,000 characters)

Joint Dose Exploration Phase:

In this phase of the dose-escalation design, the SYS6026 study plan establishes two dose groups. Enlonstobart is administered according to a fixed-dose regimen. The addition of additional dose levels for SYS6026 or the investigation of dosing intervals will be determined based on a comprehensive analysis of data from the monotherapy phase of SYS6026 in advanced solid tumors and the HSIL study.

Queue expansion phase: This phase comprises three queues that receive combined treatment with SYS6026 and Enlonstobart according to the selected RED dosing regimen determined through dose exploration.

Cohort 1 (Cervical Cancer Cohort) will enroll participants with HPV16/18-positive advanced cervical cancer who had failed at least one line of standard treatment,.

Cohort 2 (Other Solid Tumor Cohort) will enroll participants with HPV16/18 positive and other advanced solid tumors (including anal cancer, vaginal cancer, vulvar cancer, oropharyngeal cancer, oral cancer, laryngeal cancer, penile cancer, etc.) who had failed at least one line of standard therapy.

Cohort 3 (a randomized controlled cohort for first-line maintenance therapy in cervical cancer) will enroll participants with advanced recurrent or metastatic cervical cancer who have achieved response or disease stability after receiving first-line platinum-based chemotherapy plus Enlonstobart PD-(L)1 inhibitor ± bevacizumab,。

Conditions: Solid Tumor
Being tested: SYS6026 combined with Enlonstobart therapy
Keywords: solid tumors

What participants receive

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

SYS6026 combined with Enlonstobart therapyDrug
SYS6026 combined with Enlonstobart therapy

Study groups in NCT07684261
Study group	Role	What they receive
SYS6026 + Enlonstobart		SYS6026 + Enlonstobart Receives: Drug: SYS6026 combined with Enlonstobart therapy
SYS6026 + Enlonstobart ± bevacizumab		SYS6026 + Enlonstobart ± bevacizumab Receives: Drug: SYS6026 combined with Enlonstobart therapy

What is being measured

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

DLT incidence
Measured: 24 Months

Timeline

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

20 Jul 202631 Dec 2029

First posted6 Jul 2026
Study start20 Jul 2026 (estimated)
Primary completion31 Dec 2028 (estimated)
Study completion31 Dec 2029 (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.
More trials run by CSPC Megalith Biopharmaceutical Co.,Ltd.The 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 186 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07684261
Sponsor's protocol ID: SYS6026-003
Status last verified: Jun 2026
First submitted: 29 Jun 2026
Last updated: 6 Jul 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruitingObservational study
Implementation Development for Distress Screening in Pediatric Oncology (ID-DISTRESSS)
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Not yet recruitingPhase 1/2
Study on GD2 Positive Solid Tumors by 4SCAR-GD2
Solid Tumor
Active, not recruitingPhase 2
Genetic Testing in Guiding Treatment for Patients With Brain Metastases
CDK Gene Mutation, Metastatic Malignant Neoplasm in the Brain
RecruitingPhase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Advanced Solid Tumors, Metastatic Pancreatic Cancer
Active, not recruiting
The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

All Solid Tumor trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-label, Phase II Clinical Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics (PK), and Immunogenicity of the Combination Therapy of SYS6026 in the Treatment of Advanced Solid Tumors
ClinicalTrials.gov ID: NCT07684261
Acronym / sponsor ID: SYS6026-003
Conditions: Solid Tumor
Keywords: solid tumors
Study type: Observational
Recruitment status: Not yet recruiting
Enrolment: 186 participants (estimated)
Lead sponsor: CSPC Megalith Biopharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
Study start: 20 Jul 2026 (estimated)
Primary completion: 31 Dec 2028 (estimated)
Study completion: 31 Dec 2029 (estimated)
First posted: 6 Jul 2026 (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.

Detailed description

(Limit: 32,000 characters)

Joint Dose Exploration Phase:

Cohort 1 (Cervical Cancer Cohort) will enroll participants with HPV16/18-positive advanced cervical cancer who had failed at least one line of standard treatment,.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
SYS6026 + Enlonstobart	–	Drug: SYS6026 combined with Enlonstobart therapySYS6026 + Enlonstobart
SYS6026 + Enlonstobart ± bevacizumab	–	Drug: SYS6026 combined with Enlonstobart therapySYS6026 + Enlonstobart ± bevacizumab

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: participate advanced solid tumors

Key inclusion criteria (25 listed)

Age ≥18 years;
Confirmation by the research center of HPV type 16 and/or 18 infection in tumor tissue;
Pathologically confirmed unresectable locally advanced or metastatic solid tumor;
ECOG PS score of 0-1;
Estimated survival of at least 3 months;

Key exclusion criteria (22 listed)

Tumor tissue testing reveals co-infection with other high-risk HPV types;
Presence of two primary tumors (applicable only to Cohort 3); for patients not in Cohort 3, inclusion is permitted if they have two primary cancers that are unsuitable for surgery, have failed standard treatment, and are considered by investigators to benefit from this study;
Adverse reactions from prior antitumor therapy have not yet resolved to CTCAE Grade V5.0 level ≤1 (excluding alopecia or participants deemed clinically insignificant by investigators);
Participation in other clinical trials involving the study drug within 28 days prior to first administration/randomization, excluding observational (non-interventional) trials or follow-up phases of intervention trials;
Previous long-term (≥7 days) systemic use of immunosuppressants or initial systemic immunosuppressive therapy within 14 days prior to first administration/randomization;

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
SYS6026 combined with Enlonstobart therapySYS6026 combined with Enlonstobart therapy	Drug	SYS6026 + Enlonstobart, SYS6026 + Enlonstobart ± bevacizumab

Primary outcome

DLT incidence
Time frame: 24 Months

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 6 Jul 2026.

Related trials for Solid Tumor

Not yet recruitingObservational study
Implementation Development for Distress Screening in Pediatric Oncology (ID-DISTRESSS)
Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
Not yet recruitingPhase 1/2
Study on GD2 Positive Solid Tumors by 4SCAR-GD2
Solid Tumor
Active, not recruitingPhase 2
Genetic Testing in Guiding Treatment for Patients With Brain Metastases
CDK Gene Mutation, Metastatic Malignant Neoplasm in the Brain
RecruitingPhase 1
Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
Advanced Solid Tumors, Metastatic Pancreatic Cancer
Active, not recruiting
The Effect of Exercise and Nicotinamide Riboside Muscle Health and Insulin Resistance in Survivors of Childhood Cancer
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Solid Tumor, run by CSPC Megalith Biopharmaceutical Co.,Ltd..

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 25 inclusion and 22 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: opening soon, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

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.

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?

DLT incidence (time frame: 24 Months). 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 NCT07684261.

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 6 Jul 2026; AzTrials last refreshed its copy on 2 Nov 2026.