Small Cell Lung CancerPhase 1NCT06970795
A Study of SYS6040 for Injection in Patients With Advanced Solid Tumors
A Phase 1 study testing SYS6040 for injection in people with Small Cell Lung Cancer and Other Advanced Solid Tumors, run by CSPC Megalith Biopharmaceutical Co.,Ltd. at 1 site in China.
Trial summary
This study is the first-in-human Phase I study of SYS6040 for injection, comprising two phases: Dose escalation with backfill (Phase Ia) and cohort expansion (Phase Ib).The planned study population consists of subjects with advanced solid tumors.The objective is to evaluate the safety, tolerability, pharmacokinetics… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small Cell Lung Cancer, Other Advanced Solid Tumors
- What is being tested?
- SYS6040 for injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2025to 30 Nov 2028
- 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
- 1）Aged ≥18 years; 2) Subjects with histologically or cytologically confirmed advanced solid tumors who have failed standard therapy, are intolerant to standard therapy, or have no options of standard of care. During cohort expansion, subjects will be enrolled as follows: Cohort 1: SCLC subjects who failed or were intolerant to at least one prior platinum-containing chemotherapy regimen; Cohort 2: Subjects with DLL3-positive malignant solid tumors who failed standard therapy, are intolerant to standard therapy, or have no options of standard of care.
- 3) At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST v1.1); 4) ECOG score of 0 or 1; 5) Life expectancy ≥3 months; 6) Laboratory parameters meeting the following criteria:
- Neutrophil count ≥1.5×109/L;
- Platelet count ≥100×109/L;
- Hemoglobin ≥9 g/dL;
- Total bilirubin ≤1.5×ULN, ALT and AST ≤2.5×ULN (In cases with liver metastases: total bilirubin ≤3×ULN and ALT/AST ≤5×ULN);
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- Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min;
- International Standardized Ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN.
- Fertile males and females must use reliable contraception throughout the study period and for 9 months after the last dose. Females aged 18-60 years must have negative blood pregnancy results within 7 days before the first dose.
- 7) Understand and voluntarily sign the informed consent form (ICF).
Who cannot join
- Having received systemic antitumor therapy within 4 weeks before first dose, including: Chemotherapy, macromolecular targeted therapy, antiangiogenic therapy, biotherapy, immunotherapy, radiotherapy (except palliative radiotherapy for bone metastasis pain relief), except:
- Oral fluorouracil agents and small molecule targeted drugs within 2 weeks before first dose or within 5 half-lives (whichever is longer);
- Traditional Chinese medicines with antitumor indications within 2 weeks before first dose.
- Used or required to use strong CYP3A4 inhibitors/inducers within 2 weeks before first dose or during the study;
- Previous treatment with antibody-drug conjugates (ADCs) containing topoisomerase I inhibitors as payload;
- Having received systemic corticosteroid therapy (>10 mg prednisone equivalent daily for >7 days) or other immunosuppressants within 2 weeks before treatment initiation (inhaled/topical steroids or adrenal replacement therapy >10 mg prednisone equivalent permitted without active autoimmune disease);
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- Having received transfusion, EPO, TPO, IL-11, G-CSF or GM-CSF therapy within 2 weeks before first dose;
- Having used or required to use QT-prolonging/shortening drugs within 7 days before first dose or during C-QTc study period, or have risk factors for QT prolongation/arrhythmia (e.g., heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death in first-degree relatives <40 years);
- Severe cardiovascular/cerebrovascular disease history；
- History of other primary malignancies (except cured localized tumors like basal cell carcinoma, squamous cell carcinoma of skin, superficial bladder cancer, carcinoma in situ of prostate/cervix/breast, or subjects with other primary tumors showing no recurrence for ≥5 years);
- Clinically confirmed active pneumonia at screening or history of interstitial lung disease;
- Uncontrolled serous effusions requiring frequent drainage or medical intervention at screening (e.g., pleural/peritoneal/pericardial effusions needing additional intervention within 2 weeks after initial treatment, excluding cytological examination);
- Brain metastases or spinal cord compression at screening (except those completing local therapy with ≥4-week steroid discontinuation and stable imaging/neurological symptoms for ≥4 weeks before treatment initiation);
- Severe unhealed wounds/ulcers/fractures, or major surgery within 4 weeks before first dose, or planned elective surgery during study;
- Clinically confirmed active HBV or HCV.Active HBV definition: HBcAb or HBsAg positive with HBV DNA above ULN; Active HCV definition: HCV antibody positive with HCV RNA above ULN;
- Active tuberculosis confirmed clinically, or TP-Ab positive, or HIV-Ab positive, or history of immunodeficiency diseases/organ transplantation/allogeneic hematopoietic stem cell transplantation;
- Significant bleeding tendency within 4 weeks before first dose, investigator-assessed high-risk of gastrointestinal hemorrhage/hemoptysis, or congenital bleeding disorders/coagulopathy;
- Active infection requiring medication or unexplained fever ≥38.5°C during screening;
- History of psychotropic substance abuse, alcoholism, or drug addiction;
- Pregnancy or lactation at screening;
- Persistent adverse reactions from prior antitumor therapy not recovered to CTCAE v5.0 ≤Grade 1 or baseline (except alopecia/nail changes/other investigator-deemed non-safety concerns);
- Investigator-determined ineligibility for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Jilin Cancer Hospital
Changchuan, Jilin, 130021
YING CHENG CHENG, Bachelor, 0431-80596003, jl.cheng@163.com
About this study
Official title: An Open-lable, Multicenter Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of SYS6040 for Injection as a Single Agent in Participants With Advanced Solid Tumors
This study is the first-in-human Phase I study of SYS6040 for injection, comprising two phases: Dose escalation with backfill (Phase Ia) and cohort expansion (Phase Ib).The planned study population consists of subjects with advanced solid tumors.The objective is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SYS6040 for injection as monotherapy in participants with advanced solid tumors.
Read the detailed description
The dose escalation phase utilizes a BOIN design for dose escalation. Subjects in five predefined dose groups will administer investigational product via intravenous infusion. Subjects will be enrolled in groups of 3 for treatment.The first treatment cycle (21 days) will serve as the DLT observation window, with dose escalation/de-escalation decisions based on DLT occurrences.
Each cohort is planned to enroll 20-40 subjects, receiving RP2D doses every 3 weeks (Day 1).
Subjects will receive RP2D doses in 21-day treatment cycles until PD, intolerable toxicity, consent withdrawal, loss to follow-up, investigator-determined unsuitability for continued treatment, death, or study termination, whichever occurs first.
- Being tested
- SYS6040 for injection
- Medical subject headings
- Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SYS6040 for injectionDrug
Intravenous infusion; including dose escalation and backfilling (5 preset dose groups) and cohort expansion.
Treatment Period: All subjects receive trial treatment until disease progression, death, intolerance of toxicity, loss to follow-up, withdrawal of consent, or end of the trial (whichever occurs first)
| Study group | Role | What they receive |
|---|---|---|
| SYS6040 for injection as single agent | Experimental | Not described Receives: Drug: SYS6040 for injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT（Phase 1a）
Incidence rate and category of dose limiting toxicities (DLTs) during the first 21-day cycle of SYS6040 treatment
Measured: Up to approximately 21days
Frequency and severity of TEAE and SAE（Phase 1a）
Assess safety and tolerability of SYS6040
Measured: Up to approximately 2years
RP2D (Phase 1a）
RP2D was determined based on the safety, tolerability, PK, immunogenicity data and efficacy information obtained
Measured: Up to approximately 2 years
ORR（Phase 1b）
Objective response rate (ORR) as evaluated by Investigator (RECIST1.1).
Measured: Up to approximately 2 years
Secondary outcomes (16)
Peak time(Tmax)（phase 1a）
Peak time(Tmax) after a single administration of SYS6040
Measured: Up to approximately 2 years
Maximum plasma concentration (Cmax) （phase 1a）
Cmax after a single administration of SYS6040
Measured: Up to approximately 2 years
AUC 0-t（phase 1a）
Area under blood concentration - time curve(AUC 0-∞) after a single administration
Measured: Up to approximately 2 years
AUC 0-∞（phase 1a）
Area under blood concentration - time curve(AUC 0-∞) after a single administration
Measured: Up to approximately 2 years
Steady state peak concentration(Cmax,ss) （phase 1a）
Steady state peak concentration(Cmax,ss) after repeated administration
Measured: Up to approximately 2 years
Steady state valley concentration(Cmin,ss) （phase 1a）
Steady state valley concentration(Cmin,ss) after repeated administration
Measured: Up to approximately 2 years
DoR
Duration of response
Measured: Up to approximately 2 years
DCR
Disease control rate
Measured: Up to approximately 2 years
ORR（Phase 1a）
Objective response rate (ORR) as evaluated by Investigator (RECIST1.1).
Measured: Up to approximately 2years
OS
Overall survival
Measured: Up to approximately 2 years
PFS
Progression-free survival (PFS) as evaluated by Investigator (RECIST1.1).
Measured: Up to approximately 2 years
Anti-SYS6040 antibodies
Anti-drug antibody (ADA) incidence and titer.
Measured: Up to approximately 2 years
Adverse events (AEs)（Phase 1b）
Incidence and severity of AEs
Measured: Up to approximately 2 years
Plasma concentrations of toxin-bound antibodies
Tests are conducted after administration of SYS6040.
Measured: Up to approximately 2 years
Plasma concentrations of total antibodies
Tests are conducted after administration of SYS6040.
Measured: Up to approximately 2 years
Plasma concentrations of free toxin
Tests are conducted after administration of SYS6040.
Measured: Up to approximately 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start10 Apr 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Cell Lung CancerStudies 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is the first-in-human Phase I study of SYS6040 for injection, comprising two phases: Dose escalation with backfill (Phase Ia) and cohort expansion (Phase Ib).
- Masking
- None (open label)
- Enrolment
- 180 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
- NCT06970795
- Sponsor's protocol ID
- SYS6040
- Status last verified
- Apr 2025
- First submitted
- 2 Apr 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-lable, Multicenter Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile and Preliminary Efficacy of SYS6040 for Injection as a Single Agent in Participants With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT06970795
- Acronym / sponsor ID
- SYS6040
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- CSPC Megalith Biopharmaceutical Co.,Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 14 May 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.
This study is the first-in-human Phase I study of SYS6040 for injection, comprising two phases: Dose escalation with backfill (Phase Ia) and cohort expansion (Phase Ib).The planned study population consists of subjects with advanced solid tumors.The objective is to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of SYS6040 for injection as monotherapy in participants with advanced solid tumors.
Detailed description
The dose escalation phase utilizes a BOIN design for dose escalation. Subjects in five predefined dose groups will administer investigational product via intravenous infusion. Subjects will be enrolled in groups of 3 for treatment.The first treatment cycle (21 days) will serve as the DLT observation window, with dose escalation/de-escalation decisions based on DLT occurrences.
Each cohort is planned to enroll 20-40 subjects, receiving RP2D doses every 3 weeks (Day 1).
Subjects will receive RP2D doses in 21-day treatment cycles until PD, intolerable toxicity, consent withdrawal, loss to follow-up, investigator-determined unsuitability for continued treatment, death, or study termination, whichever occurs first.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is the first-in-human Phase I study of SYS6040 for injection, comprising two phases: Dose escalation with backfill (Phase Ia) and cohort expansion (Phase Ib).
| Arm | Type | Receives |
|---|---|---|
| SYS6040 for injection as single agent | Experimental | Drug: SYS6040 for injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1）Aged ≥18 years; 2) Subjects with histologically or cytologically confirmed advanced solid tumors who have failed standard therapy, are intolerant to standard therapy, or have no options of standard of care. During cohort expansion, subjects will be enrolled as follows: Cohort 1: SCLC subjects who failed or were intolerant to at least one prior platinum-containing chemotherapy regimen; Cohort 2: Subjects with DLL3-positive malignant solid tumors who failed standard therapy, are intolerant to standard therapy, or have no options of standard of care.
- 3) At least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST v1.1); 4) ECOG score of 0 or 1; 5) Life expectancy ≥3 months; 6) Laboratory parameters meeting the following criteria:
- Neutrophil count ≥1.5×109/L;
- Platelet count ≥100×109/L;
- Hemoglobin ≥9 g/dL;
Key exclusion criteria (22 listed)
- Having received systemic antitumor therapy within 4 weeks before first dose, including: Chemotherapy, macromolecular targeted therapy, antiangiogenic therapy, biotherapy, immunotherapy, radiotherapy (except palliative radiotherapy for bone metastasis pain relief), except:
- Used or required to use strong CYP3A4 inhibitors/inducers within 2 weeks before first dose or during the study;
- Previous treatment with antibody-drug conjugates (ADCs) containing topoisomerase I inhibitors as payload;
- Having received systemic corticosteroid therapy (>10 mg prednisone equivalent daily for >7 days) or other immunosuppressants within 2 weeks before treatment initiation (inhaled/topical steroids or adrenal replacement therapy >10 mg prednisone equivalent permitted without active autoimmune disease);
- Having received transfusion, EPO, TPO, IL-11, G-CSF or GM-CSF therapy within 2 weeks before first dose;
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 |
|---|---|---|
| SYS6040 for injectionIntravenous infusion; including dose escalation and backfilling (5 preset dose groups) and cohort expansion. Treatment Period: All subjects receive trial treatment until disease progression, death, intolerance of toxicity, loss to follow-up, withdrawal of consent, or end of the trial (whichever occurs first) | Drug | SYS6040 for injection as single agent |
Primary outcome
DLT（Phase 1a）
Time frame: Up to approximately 21days
Incidence rate and category of dose limiting toxicities (DLTs) during the first 21-day cycle of SYS6040 treatment
Frequency and severity of TEAE and SAE（Phase 1a）
Time frame: Up to approximately 2years
Assess safety and tolerability of SYS6040
RP2D (Phase 1a）
Time frame: Up to approximately 2 years
RP2D was determined based on the safety, tolerability, PK, immunogenicity data and efficacy information obtained
ORR（Phase 1b）
Time frame: Up to approximately 2 years
Objective response rate (ORR) as evaluated by Investigator (RECIST1.1).
16 secondary outcomes
Peak time(Tmax)（phase 1a）
Time frame: Up to approximately 2 years
Maximum plasma concentration (Cmax) （phase 1a）
Time frame: Up to approximately 2 years
AUC 0-t（phase 1a）
Time frame: Up to approximately 2 years
AUC 0-∞（phase 1a）
Time frame: Up to approximately 2 years
Steady state peak concentration(Cmax,ss) （phase 1a）
Time frame: Up to approximately 2 years
Steady state valley concentration(Cmin,ss) （phase 1a）
Time frame: Up to approximately 2 years
DoR
Time frame: Up to approximately 2 years
DCR
Time frame: Up to approximately 2 years
ORR（Phase 1a）
Time frame: Up to approximately 2years
OS
Time frame: Up to approximately 2 years
PFS
Time frame: Up to approximately 2 years
Anti-SYS6040 antibodies
Time frame: Up to approximately 2 years
Adverse events (AEs)（Phase 1b）
Time frame: Up to approximately 2 years
Plasma concentrations of toxin-bound antibodies
Time frame: Up to approximately 2 years
Plasma concentrations of total antibodies
Time frame: Up to approximately 2 years
Plasma concentrations of free toxin
Time frame: Up to approximately 2 years
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 14 May 2025.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SYS6040 for injection in people with Small Cell Lung Cancer and Other 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 10 inclusion and 22 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: looking for participants now, as of the sponsor's last update on 14 May 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 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT（Phase 1a） (time frame: Up to approximately 21days). 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?
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 May 2025.