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Advanced Solid TumorsPhase 1NCT07873359

A Clinical Trial to Evaluate the Safety and Tolerability of SYS6077 Injection in Participants With Advanced Malignant Tumor

A Phase 1 study testing SYS6077 in people with Advanced Solid Tumors, run by Beijing Kangchuanglian Biopharmaceutical Technology Research Co., Ltd.

Not yet recruiting

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

Sites and contacts
Official record
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Trial summary

This trial is a multi-center, phase I clinical study to evaluate the safety/tolerability, immunogenicity, pharmacokinetic characteristics and preliminary anti-tumor activity of different doses of SYS6077 in patients with malignant tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
SYS6077
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
No sites listed yet
Study dates
22 Nov 2026to 22 Nov 2031
Phase
Phase 1
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

  • Age ≥ 18 years
  • Malignant solid tumors confirmed by histology or cytology
  • Failure of standard treatment or intolerable toxicity, or no standard treatment (Phase Ia)
  • At least one measurable lesion meeting RECIST 1.1 criteria at baseline (the measurable lesion area has not received previous radiotherapy, or there is evidence that the lesion has clearly progressed after the end of radiotherapy) (only applicable to dose expansion)
  • ECOG PS score 0-1
  • Expected survival period ≥ 3 months
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  • Adequate organ function, meeting the following criteria within 7 days before the first administration:
  • Hematology (without blood transfusion, EPO, G-CSF within 14 days prior to the first administration): absolute neutrophil count ≥ 1.5 × 109/L; Platelets ≥ 100 × 109/L; Hemoglobin ≥ 90 g/L; Liver function: total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN for patients with Gilbert's syndrome); Alanine aminotransferase and aspartate aminotransferase ≤ 2.5 × ULN (≤ 5 × ULN for participants with liver metastases); Renal function: serum creatinine ≤ 1.5 × ULN. When serum creatinine > 1.5 × ULN, creatinine clearance (Ccr) should be calculated according to Cockcroft-Gault formula and be ≥ 60 ml/min; Coagulation (without anticoagulant therapy): prothrombin time or international normalized ratio ≤ 1.5 × ULN.
  • -Participants must give informed consent to this study before the trial and voluntarily sign a written informed consent form.

Who cannot join

  • Subjects with a history of severe allergies; Known hypersensitivity or intolerance to any component of the vaccine or its excipients;
  • Subjects with central nervous system metastasis or meningeal metastasis. Patients who have undergone targeted radiotherapy or surgical treatment and have no clinical symptoms and signs without drug symptomatic treatment can be enrolled;
  • Subjects with tumor invasion of important arteries leading to high risk of bleeding, obvious risk of perforation, or fistula formation;
  • Uncontrolled pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
  • Adverse events of previous anti-tumor treatment (including radiotherapy) have not recovered to CTCAE 6.0 ≤ Grade 1 (except for some toxicities such as alopecia and fatigue that are judged by the investigator to have no safety risk);
  • Diagnosed with a second primary malignant tumor within 5 years before the first administration of the study drug; Except for effectively treated basal cell carcinoma of skin, squamous cell carcinoma of skin, and/or effectively resected cervical cancer and/or breast cancer in situ;
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  • Received chemotherapy, biological therapy, targeted therapy and other anti-tumor treatments within 21 days before the first administration of the study drug, among which: oral small molecule targeted drugs are within 14 days before the first dose of the study drug or within 5 half-lives of known drugs (whichever is longer); Radiotherapy within 14 days prior to the first administration of study drug; Traditional Chinese medicine or Chinese patent medicine with anti-tumor indications within 7 days before the first administration of the study drug;
  • Received live or live-attenuated vaccines within 28 days prior to the first administration of study drug or planned to receive during the study;
  • Received palliative treatment for local lesions (including local radiotherapy or other local treatments) within 14 days before the first administration of the study drug;
  • Have undergone major surgery (excluding puncture biopsy) or severe traumatic injury 28 days before the first administration of the study drug;
  • Subjects with a history of severe cardiovascular disease, including but not limited to:
  • Baseline complete left bundle branch block or third-degree atrioventricular block;
  • Baseline unstable angina and myocardial infarction within 6 months;
  • Prolonged QT/QTc interval at baseline (QTcF > 450 ms for males and > 480 ms for females);
  • Severe arrhythmia at baseline, which is judged by the investigator to have an impact on this trial;
  • Left ventricular ejection fraction ≤ 50% by baseline echocardiography or multi-gated acquisition technique;
  • Baseline heart failure, NYHA class II or above;
  • Baseline poorly controlled hypertension (blood pressure greater than or equal to 160/110 mmHg despite optimal therapy);
  • Previous or current cardiomyopathy that, in the opinion of the investigator, has an impact on this trial.
  • History of autoimmune diseases (except for psoriasis/alopecia/vitiligo that does not require systemic treatment and is in stable condition in the past year, type 1 diabetes mellitus that uses stable doses and has stable blood sugar control, subclinical hypothyroidism, hypothyroidism that does not require hormone replacement therapy or is in stable condition after hormone replacement therapy, and other diseases suitable judged by the investigator);
  • History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or organ transplantation;
  • Infectious diseases requiring systemic anti-infective (such as antibiotics, antiviral or antifungal drugs) treatment (except those with controllable infection-related risks after administration of the study drug judged by the investigator);
  • Active hepatitis B (hepatitis B virus DNA assay > 1000 copies/mL or 200 IU/mL); Hepatitis C infection (hepatitis C antibody positive and HCV-RNA above the lower limit of detection at the study site); Active syphilis infection, active tuberculosis;
  • Lactating or pregnant women; Women of childbearing potential have a positive blood pregnancy test within 7 days prior to trial enrollment; [A participant is of childbearing potential (judged by the investigator) when he/she is biologically capable of fathering a child and is sexually active. Female participants who are not of childbearing potential (i.e., meet at least 1 of the following criteria): have had a hysterectomy or bilateral oophorectomy, or have medically confirmed ovarian failure, or are medically confirmed postmenopausal (cessation of menses for at least 12 consecutive months without a pathological or physiological cause).]
  • Any male and female participants of childbearing potential who refuse to use effective contraceptive methods throughout the trial and within half a year after the last dose;
  • Other conditions that the investigator believes will affect the safety or compliance of the study drug treatment, including but not limited to: mental illness, any severe or uncontrolled disease, etc.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Clinical Trials Information Group Officer contact

+86-311 6908 5587

ctr-contact@cspc.cn

About this study

Official title: A Phase I Clinical Trial to Evaluate the Safety and Tolerability of SYS6077 Injection in Participants With Advanced Malignant Tumor

This trial is a multi-center, phase I clinical study to evaluate the safety/tolerability, immunogenicity, pharmacokinetic characteristics and preliminary anti-tumor activity of different doses of SYS6077 in patients with malignant tumors.

Being tested
SYS6077

What participants receive

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

  • SYS6077Biological

    Dose 1 of SYS6077

  • SYS6077Biological

    Dose 2 of SYS6077

  • SYS6077Biological

    Dose 3 of SYS6077

Study groups in NCT07873359
Study groupRoleWhat they receive
Dose 1 of SYS6077ExperimentalNot described
Receives: Biological: SYS6077
Dose 2 of SYS6077ExperimentalNot described
Receives: Biological: SYS6077
Dose 3 of SYS6077ExperimentalNot described
Receives: Biological: SYS6077

What is being measured

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

  1. Incidence and severity of adverse events (AEs)

    Assess safety and tolerability of SYS6077

    Measured: Up to approximately 5 years

  2. Incidence and severity of serious adverse events (SAEs)

    Occurrence of serious adverse events (SAEs)

    Measured: Up to approximately 5 years

  3. Incidence rate and category of dose limiting toxicities (DLTs)

    DLTs during the first 21-day cycle of SYS6077 treatment

    Measured: Up to approximately 21days

Secondary outcomes (8)

  1. Peak time (Tmax)

    Tmax after administration of SYS6077

    Measured: Up to 43 days

  2. Maximum plasma concentration (Cmax)

    Cmax after a single administration of SYS6077

    Measured: Up to 43 days

  3. Objective response rate (ORR)

    Objective response rate (ORR)

    Measured: Up to approximately 5 years

  4. Progression-free survival (PFS)

    Progression-free survival (PFS)

    Measured: Up to approximately 5 years

  5. Disease control rate (DCR)

    Disease control rate (DCR)

    Measured: Up to approximately 5 year

  6. Duration of response (DoR)

    Duration of response (DoR)

    Measured: Up to approximately 5 years

  7. Time to response (TTR)

    Time to response (TTR)

    Measured: Up to approximately 5 years

  8. Overall survival (OS)

    Measured: Up to approximately 5 years

Timeline

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

  1. First posted14 Oct 2026
  2. Study start22 Nov 2026 (estimated)
  3. Primary completion30 Dec 2028 (estimated)
  4. Study completion22 Nov 2031 (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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07873359
Sponsor's protocol ID
SYS6077-001
Status last verified
Sep 2026
First submitted
30 Sep 2026
Last updated
14 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SYS6077 in people with Advanced Solid Tumors, run by Beijing Kangchuanglian Biopharmaceutical Technology Research 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 9 inclusion and 26 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 14 Oct 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.

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?

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 Clinical Trials Information Group Officer (+86-311 6908 5587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of adverse events (AEs) (time frame: Up to approximately 5 years). 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 NCT07873359.

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 14 Oct 2026.

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