Advanced Solid TumorsPhase 1/2NCT07897227
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of SYS6062 in Patients With Advanced Solid Tumors.
A Phase 1/2 study testing SYS6062 in people with Advanced Solid Tumors and Gastric Cancer (GC), run by CSPC Megalith Biopharmaceutical Co.,Ltd..
Trial summary
This study is a multicenter, open-label, dose-escalation, PK expansion, and cohort expansion, first-in-human phase I/II study to evaluate the safety, tolerability, PK profile, and preliminary antitumor efficacy of SYS6062, a CEACAM5-targeted antibody-conjugate drug, in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors, Gastric Cancer (GC), Colorectal Cancer (CRC)
- What is being tested?
- SYS6062
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Nov 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-75 years (inclusive) (based on the day of signing the informed consent form).
- Histologically or cytologically confirmed advanced/unresectable, or metastatic solid tumors that have relapsed or progressed on or after standard systemic treatment, or are intolerant to standard treatment, or no standard treatment is available.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) (not required in the dose escalation phase).
- ECOG score 0-1.
- Participant is expected to survive ≥ 3 months.
- The vital organ functions (hematology, liver and kidney function, coagulation function, etc.) meet the protocol requirements within 7 days prior to enrollment.
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- Toxicity caused by any previous treatment has recovered to CTCAE 6.0 ≤ Grade 1 or baseline level.
- Adequate treatment washout period for prior antineoplastic therapy prior to the first dose.
- Able to provide a prior resected tumor sample or willing to undergo a fresh tumor biopsy.
- Female participants of childbearing potential have a negative serum pregnancy test within 7 days prior to enrollment. Male and female participants of childbearing potential must agree to use adequate contraception during the study and for at least 7 months after the last dose of study drug; During this period, women must not be breastfeeding, male participants must not freeze or donate sperm, and female participants must not donate or retrieve ova for their own use.
- Fully understand this clinical trial and voluntarily sign a written informed consent form.
Who cannot join
- Prior treatment with CEACAM5-targeted therapy or TOP1 ADC agents.
- History of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] Class II-IV) or serious arrhythmia requiring treatment.
- History of myocardial infarction or unstable angina within 6 months prior to enrollment.
- Male and female mean QT interval corrected by Fredericia's formula (QTcF) prolongation to > 470 msec in females or > 450 msec in males based on triplicate 12-lead electrocardiograms (ECGs).
- Inability or unwillingness to discontinue concomitant medications known to prolong the QT interval.
- Has a history of interstitial lung disease (e.g., non-infectious interstitial pneumonitis, pulmonary fibrosis, and severe radiation pneumonitis) or current interstitial lung disease or is suspected to have this disease by imaging at screening.
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- History of underlying pulmonary disease, including but not limited to pulmonary embolism within 3 months of starting study treatment, severe asthma, severe COPD, restrictive lung disease, and other clinically significant pulmonary compromise or requirement for supplemental oxygen.
- Any autoimmune, connective tissue or inflammatory disorders (eg, rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.) where there is documented, or a suspicion of pulmonary involvement at the time of screening.
- Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
- Known human immunodeficiency virus (HIV) infection.
- Current active syphilis infection (i.e., positive for Treponema pallidum antibodies (RPR or TRUST) or requiring systemic treatment)
- Participants with active viral (any etiology) hepatitis are excluded.
- Breastfeeding women (women who are willing to temporarily interrupt breastfeeding will also be excluded), or those who are pregnant as confirmed by pregnancy test within 7 days prior to enrollment.
- Has spinal cord compression or clinically active brain metastases, defined as untreated, symptomatic, or requiring corticosteroids or anticonvulsants to control associated symptoms. Participants with asymptomatic CNS metastases who are radiologically and neurologically stable for at least 4 weeks following CNS-directed therapy and are on stable or tapering doses of corticosteroids equivalent to ≤10 mg/day prednisone are eligible.
- Has multiple primary malignancies within 3 years prior to enrollment, except adequately resected non-melanoma skin cancer (e.g., resected basal or squamous cell skin cancer), curatively treated in situ disease (e.g., carcinoma in situ of the cervix or breast), or other solid tumors curatively treated (e.g., superficial bladder cancer).
- Substance abuse or any other medical condition that, in the opinion of the investigator, may increase the safety risk of the participant or interfere with the participant's participation in the clinical study or the evaluation of the clinical study.
- Participants who have received strong CYP3A4 inhibitors or inducers within 14 days prior to the first dose of study drug or will continue to use such drugs during the trial, or participants who receive OATP1B1 or OATP1B3 inhibitors.
- History of toxic epidermal necrolysis, Steven Johnson syndrome.
- Known hypersensitivity to study drug substance or excipients.
- Participants who, in the opinion of the investigator, have other reasons that make them unsuitable for the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
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 SYS6062 in Patients With Advanced Solid Tumors
This study is a multicenter, open-label, dose-escalation, PK expansion, and cohort expansion, first-in-human phase I/II study to evaluate the safety, tolerability, PK profile, and preliminary antitumor efficacy of SYS6062, a CEACAM5-targeted antibody-conjugate drug, in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumors, Gastric Cancer (GC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC)
- Being tested
- SYS6062
- Keywords
- SYS6062, CEACAM5, Advanced solid tumors
- Medical subject headings
- Stomach Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYS6062Biological
Intravenous infusion will be administered until disease progression or intolerable toxicity
| Study group | Role | What they receive |
|---|---|---|
| SYS6062 single-agent dose escalation, expansion, and cohort expansion | Experimental | Not described Receives: Biological: SYS6062 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (AEs) and serious adverse events (SAEs)
Measured: Up to 3 years
Dose-limiting toxicities (DLTs)
Measured: Up to approximately 1 year
Maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)
Measured: Up to approximately 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 May 2029 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07897227
- Sponsor's protocol ID
- SYS6062-001
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study of Dose Escalation, PK Expansion, and Cohort Expansion to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of SYS6062 in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT07897227
- Acronym / sponsor ID
- SYS6062-001
- Conditions
- Advanced Solid Tumors, Gastric Cancer (GC), Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC)
- Keywords
- SYS6062, CEACAM5, Advanced solid tumors
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 27 Oct 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.
This study is a multicenter, open-label, dose-escalation, PK expansion, and cohort expansion, first-in-human phase I/II study to evaluate the safety, tolerability, PK profile, and preliminary antitumor efficacy of SYS6062, a CEACAM5-targeted antibody-conjugate drug, in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SYS6062 single-agent dose escalation, expansion, and cohort expansion | Experimental | Biological: SYS6062 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Aged 18-75 years (inclusive) (based on the day of signing the informed consent form).
- Histologically or cytologically confirmed advanced/unresectable, or metastatic solid tumors that have relapsed or progressed on or after standard systemic treatment, or are intolerant to standard treatment, or no standard treatment is available.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) (not required in the dose escalation phase).
- ECOG score 0-1.
- Participant is expected to survive ≥ 3 months.
Key exclusion criteria (20 listed)
- Prior treatment with CEACAM5-targeted therapy or TOP1 ADC agents.
- History of symptomatic congestive heart failure (CHF) (New York Heart Association [NYHA] Class II-IV) or serious arrhythmia requiring treatment.
- History of myocardial infarction or unstable angina within 6 months prior to enrollment.
- Male and female mean QT interval corrected by Fredericia's formula (QTcF) prolongation to > 470 msec in females or > 450 msec in males based on triplicate 12-lead electrocardiograms (ECGs).
- Inability or unwillingness to discontinue concomitant medications known to prolong the QT interval.
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 |
|---|---|---|
| SYS6062Intravenous infusion will be administered until disease progression or intolerable toxicity | Biological | SYS6062 single-agent dose escalation, expansion, and cohort expansion |
Primary outcome
Adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 3 years
Dose-limiting toxicities (DLTs)
Time frame: Up to approximately 1 year
Maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)
Time frame: Up to approximately 1 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 27 Oct 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SYS6062 in people with Advanced Solid Tumors and Gastric Cancer (GC), 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 11 inclusion and 20 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 27 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 (86-0311-69085587, ctr-contact@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (AEs) and serious adverse events (SAEs) (time frame: Up to 3 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?
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 27 Oct 2026.