Advanced Solid TumorsPhase 1/2NCT06775236
Clinical Trial of SYS6010±SYH2051 Versus Chemotherapy in Advanced Breast Cancer and Other Solid Tumors
A Phase 1/2 study testing SYS6010 jnjection, monotherapy chemotherapy and SYH2051 tablets in people with Advanced Solid Tumors and Breast Cancer, run by CSPC Megalith Biopharmaceutical Co.,Ltd..
Trial summary
The study consists of two phases. Phase 1b and Phase 2. Phase 1b aims to evaluate the safety, tolerability, and preliminary efficacy of SYS6010 as a monotherapy and in combination with SYH2051, and to determine the recommended Phase 2 dose (RP2D) for subsequent Phase 2 studies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Breast Cancer
- What is being tested?
- SYS6010 jnjection, monotherapy chemotherapy and SYH2051 tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- No sites listed yet
- Study dates
- 20 Mar 2025to 15 Jan 2028
- 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
- 1. Age ≥ 18 years. 2. Phase 1b/Phase 2: Breast cancer (no tumor type restriction during the combination dose escalation phase).
- 3. Provide tumor tissue samples for immunohistochemical EGFR expression testing, with EGFR expression positive as confirmed by the central laboratory.
- 4. At least one measurable extracranial lesion according to RECIST v1.1 criteria (no requirement during the combination dose escalation phase of Phase 1b).
- 5. ECOG performance status score of 0-1. 6. Expected survival ≥ 3 months. 7. Major organ function meets the relevant laboratory test standards for hematology, renal function, liver function, and coagulation within 7 days prior to treatment.
- 8. Subject agrees to use effective contraception from the time of signing the informed consent form until 6 months after the last dose.
- 9. Willing to participate in the study, understand the study procedures, and sign a written informed consent form.
Who cannot join
- 1. Active central nervous system (CNS) metastases or carcinomatous meningitis. Patients with treated and stable brain metastases are eligible for inclusion.
- 2. Previously diagnosed HER2-positive breast cancer (IHC 3+ or ISH positive) (Applicable to Phase 1b Group C and Phase 2).
- 3. Previously treated with antibody-drug conjugates (ADC) containing topoisomerase I inhibitors (Applicable to Phase 1b Group C and Phase 2).
- 4. Allergy to any component of SYS6010 or SYH2051, or to humanized monoclonal antibodies.
- 5. Allergy to any component of SYS6010 or SYH2051, or to humanized monoclonal antibodies (This is a repeat of criteria #4).
- 6. Adverse events from prior antitumor therapy not recovered to ≤ Grade 1 (unless the investigator deems there is no safety risk).
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- 7. Failure to meet the required washout period for prior medications or treatments as specified in the protocol.
- 8. History of severe cardiovascular or cerebrovascular diseases. 9. History of interstitial lung disease (ILD) / non-infectious pneumonia, or current ILD/non-infectious pneumonia, or imaging findings at screening that cannot rule out these conditions.
- 10. Thyroid dysfunction requiring medication, unless the condition is controlled by medication and no dose adjustments are needed.
- 11. Severe infection within 4 weeks prior to the first use of the investigational drug.
- 12. History of discontinuing EGFR-targeted therapy for ≥ 1 month due to skin toxicity, or current skin conditions requiring medication.
- 13. Gastrointestinal diseases or functional impairments that may significantly affect the absorption of the investigational drug (e.g., ulcerative disease, severe nausea/vomiting, diarrhea, malabsorption, etc.).
- 14. Uncontrolled pleural or peritoneal effusion. 15. Active HBV or HCV infection, syphilis, HIV infection, or AIDS. 16. Other conditions deemed by the investigator as unsuitable for participation in this clinical trial.
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 1b/2 Clinical Study to Evaluate the Safety and Efficacy of SYS6010 as a Monotherapy or in Combination With SYH2051 Compared to Investigator's Choice Chemotherapy in Patients With EGFR-Expressing Advanced Unresectable or Metastatic Solid Tumors, Including But Not Limited to Breast Cancer
The study consists of two phases. Phase 1b and Phase 2. Phase 1b aims to evaluate the safety, tolerability, and preliminary efficacy of SYS6010 as a monotherapy and in combination with SYH2051, and to determine the recommended Phase 2 dose (RP2D) for subsequent Phase 2 studies. Phase 2 aims to assess the efficacy and safety of SYS6010 monotherapy or in combination with SYH2051 compared to investigator-selected chemotherapy in patients with EGFR-expressing, unresectable locally advanced or metastatic advanced breast cancer.
Read the detailed description
Phase Ⅰb Design:
Group A (SYS6010 3.2 mg/kg, Q2W):
Monotherapy Cohort: Planned enrollment of 8-12 breast cancer patients to evaluate the safety and preliminary efficacy of SYS6010 monotherapy.
Combination Cohort: Includes dose-escalation and expansion phases. Dose-escalation phase: A "3+3" design will be used to explore the safety of SYS6010 combined with SYH2051, with SYH2051 doses ranging from 60-80 mg.
Expansion phase: Upon completion of dose-escalation and confirmation of safety, breast cancer patients may be enrolled in the expansion phase.
Group B (SYS6010 3.6 mg/kg, Q2W):
Monotherapy Cohort: Planned enrollment of 8-12 breast cancer patients. Combination Cohort: Similar to Group A, with SYH2051 doses ranging from 40-60 mg.
Group C (SYS6010 3.6 mg/kg, Q2W): Enroll 40 EGFR-expressing HR+/HER2- breast cancer patients to further evaluate the safety and efficacy in this specific population.
Phase Ⅱ Design:
Based on molecular subtypes of breast cancer, cohort studies will be conducted.
Each cohort will enroll 125 patients, randomized in a 2:2:1 ratio into three groups:
SYS6010 + SYH2051 SYS6010 monotherapy Chemotherapy control.
- Conditions
- Advanced Solid Tumors, Breast Cancer
- Being tested
- SYS6010 jnjection, monotherapy chemotherapy, SYH2051 tablets
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYS6010 jnjectionDrug
SYS6010 is an antibody conjugate drug (ADC), composed of one anti-EGFR monoclonal antibody coupled to one JS1 via an enzyme specific linker
monotherapy chemotherapyDrug
Investigator's choice of monotherapy chemotherapy (Eribulin, Capecitabine, Gemcitabine, Vinorelbine, or Taxanes.)
SYH2051 tabletsDrug
SYH2051 is a Selective ATM protein kinase inhibitor
| Study group | Role | What they receive |
|---|---|---|
| SYS6010 injection | Experimental | SYS6010 injection 3.2 mg/kg or 3.6 mg/kg, intravenous drip, Q2W Receives: Drug: SYS6010 jnjection |
| SYS6010 injection + SYH2051 tablets | Experimental | SYS6010 injection 3.2 mg/kg intravenous drip + SYH2051 60 or 80 mg, oral, Q2W Or SYS6010 injection 3.6 mg/kg intravenous drip + SYH2051 40 or 60 mg, oral, Q2W Receives: Drug: SYS6010 jnjection; Drug: SYH2051 tablets |
| Monotherapy Chemotherapy Group | Active comparator | Investigator's choice of monotherapy chemotherapy （Eribulin, Capecitabine, Gemcitabine, Vinorelbine, or Taxanes. ) Receives: Drug: monotherapy chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity(DLT) occurrence and incidence
The occurrence and incidence of dose-limiting toxicities (DLTs) will be assessed based on predefined criteria during the first 28 days after the initial dose. DLTs are defined as adverse events related to the study drug that meet the protocol-specified criteria for dose limitation.
Measured: Up to approximately 3 months after the first participant is enrolled
Adverse events (AE) occurrence and incidence
The occurrence and incidence of adverse events (AEs) will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. AEs will be monitored from the first dose until the safety follow-up period.
Measured: Up to approximately 36 months after the first participant is enrolled
Objective response rate (ORR) per RECIST v1.1
The objective response rate (ORR) will be assessed based on RECIST v1.1 criteria. ORR is defined as the proportion of patients achieving a complete response (CR) or partial response (PR) as the best overall response.
Measured: Up to approximately 36 months after the first participant is enrolled
Secondary outcomes (7)
Disease control rate (DCR) per RECIST 1.1
Measured: Up to approximately 36 months after the first participant is enrolled
Duration of response (DoR) per RECIST 1.1
Measured: Up to approximately 36 months after the first participant is enrolled
Progression free survival (PFS) per RECIST 1.1
Measured: Up to approximately 36 months after the first participant is enrolled
Overall survival(OS)
Measured: Up to approximately 36 months after the first participant is enrolled
PK parameters of toxin-bound antibody
Measured: Up to approximately 36 months after the first participant is enrolled
Description :total antibody and free toxin (JS-1) after single and continuous administration of SYS6010
Measured: Up to approximately 36 months after the first participant is enrolled
PK parameters after single and multiple administrations of SYH2051
Measured: Up to approximately 36 months after the first participant is enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start20 Mar 2025 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jan 2028 (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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1b: Dose escalation and expansion Phase 2: Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 410 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
- NCT06775236
- Sponsor's protocol ID
- SYS6010-008
- Status last verified
- Jan 2025
- First submitted
- 1 Jan 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b/2 Clinical Study to Evaluate the Safety and Efficacy of SYS6010 as a Monotherapy or in Combination With SYH2051 Compared to Investigator's Choice Chemotherapy in Patients With EGFR-Expressing Advanced Unresectable or Metastatic Solid Tumors, Including But Not Limited to Breast Cancer
- ClinicalTrials.gov ID
- NCT06775236
- Acronym / sponsor ID
- SYS6010-008
- Conditions
- Advanced Solid Tumors, Breast Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 410 participants (estimated)
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Mar 2025 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jan 2028 (estimated)
- First posted
- 15 Jan 2025 (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.
The study consists of two phases. Phase 1b and Phase 2. Phase 1b aims to evaluate the safety, tolerability, and preliminary efficacy of SYS6010 as a monotherapy and in combination with SYH2051, and to determine the recommended Phase 2 dose (RP2D) for subsequent Phase 2 studies. Phase 2 aims to assess the efficacy and safety of SYS6010 monotherapy or in combination with SYH2051 compared to investigator-selected chemotherapy in patients with EGFR-expressing, unresectable locally advanced or metastatic advanced breast cancer.
Detailed description
Phase Ⅰb Design:
Group A (SYS6010 3.2 mg/kg, Q2W):
Monotherapy Cohort: Planned enrollment of 8-12 breast cancer patients to evaluate the safety and preliminary efficacy of SYS6010 monotherapy.
Combination Cohort: Includes dose-escalation and expansion phases. Dose-escalation phase: A "3+3" design will be used to explore the safety of SYS6010 combined with SYH2051, with SYH2051 doses ranging from 60-80 mg.
Expansion phase: Upon completion of dose-escalation and confirmation of safety, breast cancer patients may be enrolled in the expansion phase.
Group B (SYS6010 3.6 mg/kg, Q2W):
Monotherapy Cohort: Planned enrollment of 8-12 breast cancer patients. Combination Cohort: Similar to Group A, with SYH2051 doses ranging from 40-60 mg.
Group C (SYS6010 3.6 mg/kg, Q2W): Enroll 40 EGFR-expressing HR+/HER2- breast cancer patients to further evaluate the safety and efficacy in this specific population.
Phase Ⅱ Design:
Based on molecular subtypes of breast cancer, cohort studies will be conducted.
Each cohort will enroll 125 patients, randomized in a 2:2:1 ratio into three groups:
SYS6010 + SYH2051 SYS6010 monotherapy Chemotherapy control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Phase 1b: Dose escalation and expansion Phase 2: Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| SYS6010 injection | Experimental | Drug: SYS6010 jnjectionSYS6010 injection 3.2 mg/kg or 3.6 mg/kg, intravenous drip, Q2W |
| SYS6010 injection + SYH2051 tablets | Experimental | Drug: SYS6010 jnjection, Drug: SYH2051 tabletsSYS6010 injection 3.2 mg/kg intravenous drip + SYH2051 60 or 80 mg, oral, Q2W Or SYS6010 injection 3.6 mg/kg intravenous drip + SYH2051 40 or 60 mg, oral, Q2W |
| Monotherapy Chemotherapy Group | Active comparator | Drug: monotherapy chemotherapyInvestigator's choice of monotherapy chemotherapy （Eribulin, Capecitabine, Gemcitabine, Vinorelbine, or Taxanes. ) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Age ≥ 18 years. 2. Phase 1b/Phase 2: Breast cancer (no tumor type restriction during the combination dose escalation phase).
- 3. Provide tumor tissue samples for immunohistochemical EGFR expression testing, with EGFR expression positive as confirmed by the central laboratory.
- 4. At least one measurable extracranial lesion according to RECIST v1.1 criteria (no requirement during the combination dose escalation phase of Phase 1b).
- 5. ECOG performance status score of 0-1. 6. Expected survival ≥ 3 months. 7. Major organ function meets the relevant laboratory test standards for hematology, renal function, liver function, and coagulation within 7 days prior to treatment.
- 8. Subject agrees to use effective contraception from the time of signing the informed consent form until 6 months after the last dose.
Key exclusion criteria (13 listed)
- 1. Active central nervous system (CNS) metastases or carcinomatous meningitis. Patients with treated and stable brain metastases are eligible for inclusion.
- 2. Previously diagnosed HER2-positive breast cancer (IHC 3+ or ISH positive) (Applicable to Phase 1b Group C and Phase 2).
- 3. Previously treated with antibody-drug conjugates (ADC) containing topoisomerase I inhibitors (Applicable to Phase 1b Group C and Phase 2).
- 4. Allergy to any component of SYS6010 or SYH2051, or to humanized monoclonal antibodies.
- 5. Allergy to any component of SYS6010 or SYH2051, or to humanized monoclonal antibodies (This is a repeat of criteria #4).
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 |
|---|---|---|
| SYS6010 jnjectionSYS6010 is an antibody conjugate drug (ADC), composed of one anti-EGFR monoclonal antibody coupled to one JS1 via an enzyme specific linker | Drug | SYS6010 injection, SYS6010 injection + SYH2051 tablets |
| monotherapy chemotherapyInvestigator's choice of monotherapy chemotherapy (Eribulin, Capecitabine, Gemcitabine, Vinorelbine, or Taxanes.) | Drug | Monotherapy Chemotherapy Group |
| SYH2051 tabletsSYH2051 is a Selective ATM protein kinase inhibitor | Drug | SYS6010 injection + SYH2051 tablets |
Primary outcome
Dose-limiting toxicity(DLT) occurrence and incidence
Time frame: Up to approximately 3 months after the first participant is enrolled
The occurrence and incidence of dose-limiting toxicities (DLTs) will be assessed based on predefined criteria during the first 28 days after the initial dose. DLTs are defined as adverse events related to the study drug that meet the protocol-specified criteria for dose limitation.
Adverse events (AE) occurrence and incidence
Time frame: Up to approximately 36 months after the first participant is enrolled
The occurrence and incidence of adverse events (AEs) will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. AEs will be monitored from the first dose until the safety follow-up period.
Objective response rate (ORR) per RECIST v1.1
Time frame: Up to approximately 36 months after the first participant is enrolled
The objective response rate (ORR) will be assessed based on RECIST v1.1 criteria. ORR is defined as the proportion of patients achieving a complete response (CR) or partial response (PR) as the best overall response.
7 secondary outcomes
Disease control rate (DCR) per RECIST 1.1
Time frame: Up to approximately 36 months after the first participant is enrolled
Duration of response (DoR) per RECIST 1.1
Time frame: Up to approximately 36 months after the first participant is enrolled
Progression free survival (PFS) per RECIST 1.1
Time frame: Up to approximately 36 months after the first participant is enrolled
Overall survival(OS)
Time frame: Up to approximately 36 months after the first participant is enrolled
PK parameters of toxin-bound antibody
Time frame: Up to approximately 36 months after the first participant is enrolled
Description :total antibody and free toxin (JS-1) after single and continuous administration of SYS6010
Time frame: Up to approximately 36 months after the first participant is enrolled
PK parameters after single and multiple administrations of SYH2051
Time frame: Up to approximately 36 months after the first participant is enrolled
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 19 Mar 2025.
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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 SYS6010 jnjection, monotherapy chemotherapy and SYH2051 tablets in people with Advanced Solid Tumors and Breast Cancer, 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 6 inclusion and 13 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 19 Mar 2025. 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@cspc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity(DLT) occurrence and incidence (time frame: Up to approximately 3 months after the first participant is enrolled). 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 19 Mar 2025.