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Advanced/Metastatic Solid TumorsPhase 1/2NCT07857135

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6088 in Patients With Advanced/Metastatic Solid Tumors

A Phase 1/2 study testing SYS6088, Regorafenib and Ivonescimab in people with Advanced/Metastatic Solid Tumors, 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.

Sites and contacts
Official record
Search all trials

Trial summary

This study is a multi-center, open-label, dose-escalation, dose-expansion, and cohort-expansion first-in-human Phase 1/2 study to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor efficacy of SYS6088 in patients with advanced/metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced/Metastatic Solid Tumors
What is being tested?
SYS6088, Regorafenib and Ivonescimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
No sites listed yet
Study dates
3 Oct 2026to 3 Aug 2029
Phase
Phase 1/2
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

  • Age ≥ 18 years
  • Malignant solid tumors confirmed by histology or cytology
  • Patients who have failed standard anti-tumor treatment (disease progression or intolerance), have no available standard treatment or refuse standard treatment. (Phase 1)
  • At least one measurable lesion that meets RECIST 1.1 criteria at baseline (the measurable lesion area has not received radiotherapy previously, or there is evidence that the lesion has clearly progressed after the end of radiotherapy) exists
  • ECOG PS score ranges 0-1
  • Expected survival period ≥ 3 months
  • Adequate organ function.
  • 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 antibody drug and 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;
  • Patients with tumor invasion of important arteries leading to high risk of bleeding, obvious risk of perforation, or fistula formation; presence of diseases with impaired wound healing ability;
  • Uncontrolled pleural effusion, pericardial effusion, or ascites that requires repeated drainage;
  • Adverse reactions of previous anti-tumor treatment (including radiotherapy) have not recovered to CTCAE 6.0 ≤ Grade 1;
  • Occurrence of grade ≥3 immune-related adverse events (irAEs), or treatment discontinuation due to immune-related adverse events previously.
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  • 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 cervix cancer and/or breast cancer in situ;
  • Received chemotherapy, biological therapy, targeted therapy and other anti-tumor treatments within 21 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;
  • Use of immunosuppressive drugs within 14 days before the first administration of study drug;
  • Use drugs with anticoagulant effects within 14 days before the first administration of study drug.
  • Received palliative treatment for local lesions (including local radiotherapy or other local treatments) within 14 days before the first administration of study drug;
  • Have undergone major surgery (excluding puncture biopsy) or severe traumatic injury 28 days before the first administration of study drug;
  • Subjects with a history of severe cardiovascular disease；
  • History or presence of interstitial pneumonia/lung disease;
  • History or presence of inflammatory bowel disease
  • History of autoimmune diseases;
  • History of immunodeficiency, including positive HIV test, or other acquired or congenital immunodeficiency diseases, or organ transplantation;
  • Infectious diseases requiring systemic anti-infective treatment;
  • Active hepatitis B; Hepatitis C infection; 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 administration;
  • 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

031169085587

ctr-contact@cspc.cn

About this study

Official title: A Phase Ⅰ/Ⅱ Study of Dose Escalation, PK Expansion, and Cohort Expansion to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6088 in Patients With Advanced/Metastatic Solid Tumors

This study is a multi-center, open-label, dose-escalation, dose-expansion, and cohort-expansion first-in-human Phase 1/2 study to evaluate the safety, tolerability, PK characteristics, and preliminary anti-tumor efficacy of SYS6088 in patients with advanced/metastatic solid tumors.

Being tested
SYS6088, Regorafenib, Ivonescimab
Keywords
SYS6088, PD-1, CTLA-4, VEGF, Trispecific antibody, tumor
Medical subject headings
Parkinson Disease 4, Autosomal Dominant Lewy Body, Diabetes Mellitus, Insulin-Dependent, 12, Neoplasms

What participants receive

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

  • SYS6088Drug

    SYS6088, administered per protocol.

  • RegorafenibDrug

    Regorafenib, administered per protocol.

  • IvonescimabDrug

    Ivonescimab, administered per protocol.

Study groups in NCT07857135
Study groupRoleWhat they receive
SYS6088-Phase ⅠExperimentalPhase Ⅰ
Receives: Drug: SYS6088
SYS6088 dose 1-cohort 1 of Phase ⅡExperimentalcohort 1 of Phase Ⅱ
Receives: Drug: SYS6088
SYS6088 dose 2-cohort 1 of Phase ⅡExperimentalcohort 1 of Phase Ⅱ
Receives: Drug: SYS6088
RegorafenibActive comparatorcohort 1 of Phase Ⅱ
Receives: Drug: Regorafenib
SYS6088 dose 1-cohort 2 of Phase ⅡExperimentalcohort 2 of Phase Ⅱ
Receives: Drug: SYS6088
SYS6088 dose 2-cohort 2 of Phase ⅡExperimentalcohort 2 of Phase Ⅱ
Receives: Drug: SYS6088
SYS6088 dose 1Experimentalcohort 3 of Phase Ⅱ
Receives: Drug: SYS6088
SYS6088 dose 2-cohort 3 of Phase ⅡExperimentalcohort 3 of Phase Ⅱ
Receives: Drug: SYS6088
SYS6088Experimentalcohort 4 of Phase Ⅱ
Receives: Drug: SYS6088
IvonescimabActive comparatorcohort 4 of Phase Ⅱ
Receives: Drug: Ivonescimab

What is being measured

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

  1. The occurrence and frequency of Dose-limiting toxicities (DLTs) DLTs during the study

    Phase Ⅰ

    Measured: Up to 90 days after last administration

  2. The occurrence and frequency of Treatment-emergent adverse events (TEAEs)

    Phase Ⅰ

    Measured: Up to 90 days after last administration

  3. The maximum tolerated dose (MTD) of SYS6088 (MTD, if any)

    Phase Ⅰ

    Measured: Up to approximately 18 weeks after the first participant is enrolled

  4. The recommended Phase 2 dose (RP2D) of SYS6088

    Phase Ⅰ

    Measured: Up to approximately 36 weeks after the first participant is enrolled

  5. Objective remission rate (ORR) assessed by the investigator according to RECIST v1.1

    Phase Ⅱ

    Measured: Up to approximately 3 years

  6. The occurrence and frequency of TEAEs

    Phase Ⅱ

    Measured: Up to 90 days after last administration

Secondary outcomes (17)

  1. Plasma concentration and pharmacokinetic parameters after single and multiple doses ofSYS6088

    Phase l,Cmax

    Measured: Up to 30 days after last administration

  2. Plasma concentration and pharmacokinetic parameters after single and multiple doses ofSYS6088

    Phase l, Tmax etc.

    Measured: Up to 30 days after last administration

  3. The incidence and titer of Anti-SYS6088 antibody (if applicable);

    Phase Ⅰ

    Measured: Up to 30 days after last administration

  4. The titer of Anti-SYS6088 neutralizing antibody (if applicable);

    Phase Ⅰ

    Measured: Up to 30 days after last administration

  5. Objective response rate (ORR) as assessed by the investigator per RECIST v1.1;

    Phase Ⅰ

    Measured: Up to 30 days after last administration

  6. Progression-free survival (PFS) as assessed by the investigator per RECIST v1.1

    Phase Ⅰ

    Measured: Up to approximately 3 years

  7. Disease control rate (DCR) as assessed by the investigator per RECIST v1.1

    Phase Ⅰ

    Measured: Up to approximately 3 years

  8. Duration of response (DoR) as assessed by the investigator per RECIST v1.1;

    Phase Ⅰ

    Measured: Up to approximately 3 years

  9. Time to response (TTR) as assessed by the investigator per RECIST v1.1

    Phase Ⅰ

    Measured: Up to approximately 3 years

  10. Overall survival (OS)

    Duration from the date of initial treatment to the date of death due to any cause

    Measured: Up to approximately 5 years

  11. DCR assessed by the investigator according to RECIST v1.1;

    Phase Ⅱ

    Measured: Up to approximately 3 years

  12. PFS assessed by the investigator according to RECIST v1.1

    Phase Ⅱ

    Measured: Up to approximately 3 years

  13. DoR assessed by the investigator according to RECIST v1.1;

    Phase Ⅱ

    Measured: Up to approximately 3 years

  14. TTR assessed by the investigator according to RECIST v1.1

    Phase Ⅱ

    Measured: Up to approximately 3 years

  15. OS

    Duration from the date of initial treatment to the date of death due to any cause

    Measured: Up to approximately 5 years

  16. The incidence and titer of Anti-SYS6088 antibody (if applicable);

    Phase Ⅱ

    Measured: Up to 30 days after last administration

  17. The titer of Anti-SYS6088 neutralizing antibody (if applicable);

    Phase Ⅱ

    Measured: Up to 30 days after last

Timeline

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

  1. First posted5 Oct 2026
  2. Study start3 Oct 2026 (estimated)
  3. Primary completion3 Feb 2029 (estimated)
  4. Study completion3 Aug 2029 (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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Model description
Dose escalation, expansion and cohort expansion
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07857135
Sponsor's protocol ID
SYS6088-001
Status last verified
Sep 2026
First submitted
20 Sep 2026
Last updated
5 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SYS6088, Regorafenib and Ivonescimab in people with Advanced/Metastatic Solid Tumors, 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 8 inclusion and 23 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 5 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 combined 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.

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 Clinical Trials Information Group officer (031169085587, ctr-contact@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The occurrence and frequency of Dose-limiting toxicities (DLTs) DLTs during the study (time frame: Up to 90 days after last administration). The study lists 6 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 NCT07857135.

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 5 Oct 2026.

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