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Advanced Solid TumorsPhase 1/2NCT07122063

Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors

A Phase 1/2 study testing SYS6045 in people with Advanced Solid Tumors, run by CSPC Megalith Biopharmaceutical Co.,Ltd. at 1 site 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

This study is the first-in-human (Phase I/II) trial of SYS6045, a multicenter, open-label, dose-escalation and dose-expansion clinical study. It aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of SYS6045 in patients with HER2-positive, expressing, or… 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?
SYS6045
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
266 participants
Where
1 siteChina
Study dates
11 Aug 2025to 30 Jul 2027
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.
  • ECOG Performance Status : 0-1.
  • Tumor Lesion Requirements:
  • Dose Escalation Phase: At least one evaluable lesions per RECIST v1.1. PK Expansion Phase and Phase II (Dose Expansion Study): At least one measurable lesion per RECIST v1.1.
  • Life Expectancy: ≥3 months.
  • Adequate Organ Function (confirmed by laboratory tests within 14 days prior to enrollment, without transfusion or hematopoietic growth factor support):
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  • Absolute Neutrophil Count (ANC) ≥1.5×10⁹/L Platelet Count (PLT) ≥100×10⁹/L Hemoglobin (Hb) ≥90 g/L Total Bilirubin (TBIL) ≤1.5×ULN (≤3×ULN for participants with liver metastases or hepatocellular carcinoma) ALT/AST ≤2.5×ULN (≤5×ULN for participants with liver metastases or hepatocellular carcinoma) Serum Creatinine (Cr) <1.5×ULN Activated Partial Thromboplastin Time (APTT) ≤1.5×ULN; International Normalized Ratio (INR) ≤1.5×ULN
  • Left Ventricular Ejection Fraction (LVEF): ≥50% during screening.
  • Fertile males or females must agree to use reliable contraceptive methods (hormonal contraceptives, barrier methods, or abstinence) with their partners during the trial and for ≥7 months after the last dose. Women of childbearing potential must have a negative blood pregnancy test within 7 days before enrollment.
  • Capable of understanding and voluntarily signing the informed consent form Additional Inclusion Criteria for Phase I (Dose Escalation Phase)
  • Histologically or cytologically confirmed advanced/unresectable, or metastatic solid tumors.
  • HER2-positive, HER2-expressing, or HER2-mutated advanced solid tumors confirmed by a local laboratory (excluding lung cancer; HER2 positivity in lung cancer requires central laboratory confirmation). Prior failure of ≥1 line of standard therapy required.
  • Note: Standard therapy is defined as treatment according to established guidelines, consensus, or clinical practice standards. Treatment failure is defined as disease progression or tumor recurrence/metastasis during or after therapy.
  • Additional Inclusion Criteria for Phase I (PK Expansion Phase)
  • Histologically or cytologically confirmed advanced/unresectable, or metastatic solid tumors.
  • HER2-aberrant, HER2-expressing, or HER2-mutated advanced solid tumors confirmed by a local laboratory (Note: For lung cancer, HER2 genetic alterations may be accepted based on local reports, subject to sponsor review and approval. HER2 IHC/FISH testing for lung cancer requires central laboratory confirmation).
  • Specific Criteria for Breast Cancer Cohort: Histologically or cytologically confirmed advanced/unresectable or metastatic breast cancer.
  • Advanced/unresectable or metastatic colorectal cancer: Histologically or cytologically confirmed, HER2-aberrant (including amplification, overexpression, or mutation).
  • Advanced/unresectable or metastatic non-small cell lung cancer (NSCLC): Histologically or cytologically confirmed, HER2-aberrant).
  • Additional Inclusion Criteria for Phase II (Dose Expansion Study).
  • Documented disease progression or intolerance to the most recent systemic anti-tumor therapy based on radiological and/or pathological evidence.
  • HER2-positive, HER2-expressing, or HER2-mutated advanced solid tumors confirmed by a local laboratory (Note: For lung cancer, HER2 positivity requires central laboratory confirmation), with prior failure of at least one line of standard therapy.
  • Cohort 2a (HER2-positive breast cancer): Histologically or cytologically confirmed advanced/unresectable or metastatic breast cancer, with prior failure of ≥2 lines of standard therapy.
  • Cohort 2b (HER2-positive breast cancer): Histologically or cytologically confirmed advanced/unresectable or metastatic breast cancer, with prior failure of ≥1 line of standard therapy.
  • Cohort 2c (HER2-positive colorectal cancer): Histologically or cytologically confirmed advanced/unresectable or metastatic colorectal cancer.
  • Cohort 2d (HER2-positive non-small cell lung cancer, NSCLC): Histologically or cytologically confirmed advanced/unresectable or metastatic NSCLC.
  • Cohort 2e (Other solid tumors excluding above types): Histologically or cytologically confirmed advanced/unresectable or metastatic solid tumors (excluding breast, colorectal, and NSCLC), with HER2 expressionor HER2 mutation.

Who cannot join

  • Prior treatment with HER2-targeted ADC carrying a topoisomerase I inhibitor payload (e.g., DS-8201) or other TOP1 ADCs (Patients who received such agents in the neoadjuvant/adjuvant setting and experienced recurrence ≥12 months after treatment completion may be enrolled)[Applicable to: Phase I PK expansion and Phase II dose expansion studies].
  • Active neurological conditions, including: Spinal cord compression, clinically active brain metastases (untreated, symptomatic, or requiring corticosteroids/anticonvulsants for symptom control), carcinomatous meningitis or leptomeningeal disease. Asymptomatic CNS metastases with stable status ≥4 weeks after therapy and on tapering corticosteroids (≤10 mg/day prednisone equivalent) are allowed.
  • Chronic immunosuppressive therapy, including: Long-term immunosuppressants (e.g., cyclosporine),Systemic corticosteroids (>20 mg/day prednisone equivalent), Topical/nasal/inhaled corticosteroids are permitted.
  • Unresolved toxicities from prior anticancer therapy Not recovered to CTCAE v5.0 Grade ≤1 or baseline levels(Alopecia, hyperpigmentation, or isolated lab abnormalities deemed non-risky by the investigator).
  • Recent anticancer treatments (relative to first dose): Immunotherapy/macromolecular agents ≤4 weeks, Cytotoxic chemotherapy/small-molecule therapy ≤2 weeks, Traditional Chinese medicine ≤2 weeks.
  • Strong CYP3A4 inducers/inhibitors or OATP1B1/1B3 inhibitors≤2 weeks before first dose, or Within 5 half-lives (whichever is longer).
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  • Major surgery or invasive procedures≤28 days before first dose Planned tumor resection during the study period.
  • Known severe allergies to any component of the investigational drug, History of severe hypersensitivity to monoclonal antibodies (e.g., trastuzumab) .
  • Active bacterial, fungal, or viral infections within 14 days prior to the first dose (Defined as requiring intravenous antimicrobial, antifungal, or antiviral therapy). Subjects without clinical manifestations of active infection prior to the first dose who are receiving prophylactic anti-infective treatment may be considered for enrollment.
  • Uncontrolled serous cavity effusions requiring frequent drainage or medical intervention within 7 days prior to the first dose, includes pleural, peritoneal, or pericardial effusions necessitating additional intervention within 2 weeks post-drainage (excluding acellular cytological testing of exudates)
  • History of immunodeficiency, including positive HIV antibody test.
  • Active HBV or HCV infection: Active HBV: HBsAg-positive with HBV DNA>2000 IU/mL，Active HCV: HCV-Ab-positive with HCV RNA>upper limit of normal (ULN).
  • History of non-infectious lung disease /pneumonitis requiring steroid therapy, current interstitial lung disease (ILD)/pneumonitis, or radiographically suspected ILD/pneumonitis during screening.
  • Severe cardiovascular disease history, including but not limited to:
  • Acute coronary syndrome within 6 months prior to the first dose.
  • Stroke or transient ischemic attack within 6 months prior to the first dose.
  • Pulmonary embolism or deep vein thrombosis within 3 months prior to the first dose.
  • Symptomatic heart failure of NYHA class ≥II.
  • Documented history of pulmonary embolism.
  • Prior myocardial infarction.
  • Pericarditis or pericardial effusion requiring clinical intervention.
  • Severe cardiac rhythm/conduction abnormalities (e.g., ventricular arrhythmias requiring intervention, grade II-III atrioventricular block).
  • QTcF>450 ms (male) or>470 ms (female), or history/family history of long QT syndrome.
  • Left ventricular ejection fraction (LVEF) <50%.
  • Uncontrolled hypertension (persistent SBP≥160 mmHg and/or DBP≥100 mmHg despite antihypertensive therapy) or poor adherence to antihypertensive medications
  • Pregnancy or lactation in female participants.
  • Presence of other conditions that may interfere with the subject's participation in study procedures, are not in the subject's best interest to participate, or may affect study outcomes: such as history of psychiatric disorders, substance abuse, or any other clinically significant diseases or conditions.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Hospital of China Medical University

    Shenyang, Liaoing, 024

Other trials in China

About this study

Official title: A Multicenter, Open-Label Phase I/II Clinical Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of SYS6045 in Patients With HER2-Positive, Expressing, or Mutated Advanced Malignant Solid Tumors

This study is the first-in-human (Phase I/II) trial of SYS6045, a multicenter, open-label, dose-escalation and dose-expansion clinical study. It aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumor activity of SYS6045 in patients with HER2-positive, expressing, or mutated advanced solid tumors.

Read the detailed description

The trial consists of two parts:Phase I (dose-escalation study): divided into two segments:Dose-escalation phase and PK expansion phase Phase II (dose-expansion study)

Being tested
SYS6045

What participants receive

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

  • SYS6045Drug

    SYS6045, IV Q3W

Study groups in NCT07122063
Study groupRoleWhat they receive
SYS6045ExperimentalSYS6045,Q3W
Receives: Drug: SYS6045

What is being measured

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

  1. Dose-limiting toxicity (DLT)

    Measured: Up to 3 weeks

  2. Incidence and severity of AEs

    Measured: Up to 3 weeks

  3. Recommended Phase II Dose (RP2D)

    Measured: Up to 6 months

  4. Objective Response Rate (ORR)

    Measured: Up to 24 months

Secondary outcomes (12)

  1. Objective Response Rate (ORR)

    Assessed by investigators based on RECIST v1.1 criteria.

    Measured: Up to 24 months

  2. Disease Control Rate (DCR)

    Measured: Up to 24 months

  3. Progression-Free Survival (PFS)

    Assessed by investigators based on RECIST v1.1 criteria

    Measured: Up to 24 months

  4. Incidence and severity of AEs

    Measured: Up to 24 months

  5. Pharmacokinetic profile（AUC）

    Measured: Up to 24 months

  6. Rate of anti-SYS6045 antibodies (ADA)

    Measured: Up to 24 months

  7. Pharmacokinetic profile（Cmax）

    Measured: Up to 24 months

  8. Pharmacokinetic profile（Tmax）

    Measured: Up to 24 months

  9. Pharmacokinetic profile（t1/2）

    Measured: Up to 24 months

  10. Pharmacokinetic profile（CL）

    Measured: Up to 24 months

  11. Pharmacokinetic profile（MRT）

    Measured: Up to 24 months

  12. Rate of Neutralizing Antibodies (NAb)（if applicable）

    Measured: Up to 24 months

Timeline

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

  1. First posted14 Aug 2025
  2. Study start11 Aug 2025
  3. Primary completion30 Jul 2027 (estimated)
  4. Study completion30 Jul 2027 (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
Not applicable
Intervention model
Single group
Model description
Eligible participants will receive SYS6045 via intravenous infusion on Day 1 of each treatment cycle. Cycles repeat every 3 weeks (Q3W, every 3 weeks).
Masking
None (open label)
Enrolment
266 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07122063
Sponsor's protocol ID
SYS6045-001
Status last verified
Aug 2025
First submitted
23 Jul 2025
Last updated
14 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SYS6045 in people with Advanced Solid Tumors, run by CSPC Megalith Biopharmaceutical 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 27 inclusion and 27 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 14 Aug 2025. 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 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?

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?

Dose-limiting toxicity (DLT) (time frame: Up to 3 weeks). The study lists 4 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 NCT07122063.

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 Aug 2025.

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