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> Web page: https://trialight.com/data/trial/a-study-of-sys6040-for-injection-in-patients-with-advanced-91924654-9c89-4d0a-94d2-68be2fa2894b
> Record changed: 2026-10-13

# A Study of SYS6040 for Injection in Patients With Advanced Solid Tumors

NCT06970795

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

Phase

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

Recruitment status

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

Participants

180

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

Lead sponsor

CSPC Megalith Biopharmaceutical Co.,Ltd.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

Start date

2025-04-10

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

Number of sites

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

## Title and summary

**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 and preliminary efficacy of SYS6040 for injection as monotherapy in participants with advanced solid tumors.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

**Short title**

A Study of SYS6040 for Injection in Patients With Advanced Solid Tumors

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

**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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

## Status and phase

**Control arm**

Open label

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

**Recruitment status**

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

**Phase**

Phase 1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

## Dates

**Completion date**

2028-11-30

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

**First posted**

2025-05-14

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

**Registry last updated**

2025-05-14

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

**Primary completion date**

2027-02-28

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

**Start date**

2025-04-10

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

## Size and sites

**Participants**

180

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

**Planned participants**

180

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

**Protocol amendments**

0

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

**Number of sites**

1

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

**Lead sponsor**

CSPC Megalith Biopharmaceutical Co.,Ltd.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

## Identifiers

**Registry ID**

NCT06970795

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

**ClinicalTrials.gov ID**

NCT06970795

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

## Study design

**Allocation**

Not applicable

**Model**

Single group

**Purpose**

Treatment

**Masking**

No masking

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

## Outcomes

### Primary outcomes

1. DLT（Phase 1a）  
Timeframe: Up to approximately 21days  
Incidence rate and category of dose limiting toxicities (DLTs) during the first 21-day cycle of SYS6040 treatment
2. Frequency and severity of TEAE and SAE（Phase 1a）  
Timeframe: Up to approximately 2years  
Assess safety and tolerability of SYS6040
3. RP2D (Phase 1a）  
Timeframe: Up to approximately 2 years  
RP2D was determined based on the safety, tolerability, PK, immunogenicity data and efficacy information obtained
4. ORR（Phase 1b）  
Timeframe: Up to approximately 2 years  
Objective response rate (ORR) as evaluated by Investigator (RECIST1.1).

### Secondary outcomes

1. Peak time(Tmax)（phase 1a）  
Timeframe: Up to approximately 2 years  
Peak time(Tmax) after a single administration of SYS6040
2. Maximum plasma concentration (Cmax) （phase 1a）  
Timeframe: Up to approximately 2 years  
Cmax after a single administration of SYS6040
3. AUC 0-t（phase 1a）  
Timeframe: Up to approximately 2 years  
Area under blood concentration - time curve(AUC 0-∞) after a single administration
4. AUC 0-∞（phase 1a）  
Timeframe: Up to approximately 2 years  
Area under blood concentration - time curve(AUC 0-∞) after a single administration
5. Steady state peak concentration(Cmax,ss) （phase 1a）  
Timeframe: Up to approximately 2 years  
Steady state peak concentration(Cmax,ss) after repeated administration
6. Steady state valley concentration(Cmin,ss) （phase 1a）  
Timeframe: Up to approximately 2 years  
Steady state valley concentration(Cmin,ss) after repeated administration
7. DoR  
Timeframe: Up to approximately 2 years  
Duration of response
8. DCR  
Timeframe: Up to approximately 2 years  
Disease control rate
9. ORR（Phase 1a）  
Timeframe: Up to approximately 2years  
Objective response rate (ORR) as evaluated by Investigator (RECIST1.1).
10. OS  
Timeframe: Up to approximately 2 years  
Overall survival
11. PFS  
Timeframe: Up to approximately 2 years  
Progression-free survival (PFS) as evaluated by Investigator (RECIST1.1).
12. Anti-SYS6040 antibodies  
Timeframe: Up to approximately 2 years  
Anti-drug antibody (ADA) incidence and titer.
13. Adverse events (AEs)（Phase 1b）  
Timeframe: Up to approximately 2 years  
Incidence and severity of AEs
14. Plasma concentrations of toxin-bound antibodies  
Timeframe: Up to approximately 2 years  
Tests are conducted after administration of SYS6040.
15. Plasma concentrations of total antibodies  
Timeframe: Up to approximately 2 years  
Tests are conducted after administration of SYS6040.
16. Plasma concentrations of free toxin  
Timeframe: Up to approximately 2 years  
Tests are conducted after administration of SYS6040.

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Healthy volunteers**

No

### Inclusion criteria

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:

1. Neutrophil count ≥1.5×109/L;
2. Platelet count ≥100×109/L;
3. Hemoglobin ≥9 g/dL;
4. 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);
5. Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min;
6. International Standardized Ratio (INR) or activated partial thromboplastin time (APTT) ≤1.5×ULN.

a. 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).

### Exclusion criteria

1. 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:

  1. Oral fluorouracil agents and small molecule targeted drugs within 2 weeks before first dose or within 5 half-lives (whichever is longer);
  2. Traditional Chinese medicines with antitumor indications within 2 weeks before first dose.
2. Used or required to use strong CYP3A4 inhibitors/inducers within 2 weeks before first dose or during the study;
3. Previous treatment with antibody-drug conjugates (ADCs) containing topoisomerase I inhibitors as payload;
4. 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);
5. Having received transfusion, EPO, TPO, IL-11, G-CSF or GM-CSF therapy within 2 weeks before first dose;
6. 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);
7. Severe cardiovascular/cerebrovascular disease history；
8. 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);
9. Clinically confirmed active pneumonia at screening or history of interstitial lung disease;
10. 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);
11. 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);
12. Severe unhealed wounds/ulcers/fractures, or major surgery within 4 weeks before first dose, or planned elective surgery during study;
13. 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;
14. Active tuberculosis confirmed clinically, or TP-Ab positive, or HIV-Ab positive, or history of immunodeficiency diseases/organ transplantation/allogeneic hematopoietic stem cell transplantation;
15. Significant bleeding tendency within 4 weeks before first dose, investigator-assessed high-risk of gastrointestinal hemorrhage/hemoptysis, or congenital bleeding disorders/coagulopathy;
16. Active infection requiring medication or unexplained fever ≥38.5°C during screening;
17. History of psychotropic substance abuse, alcoholism, or drug addiction;
18. Pregnancy or lactation at screening;
19. 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);
20. Investigator-determined ineligibility for study participation.

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

## Sites

- Jilin Cancer HospitalChangchuan, ChinaRecruiting

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06970795)

## Related records

### Drugs (1)

- [Delafloxacin](https://trialight.com/data/asset/delafloxacin-70daac65-8439-49a7-b10b-4046284fc0e6.md)

### Lead sponsors (1)

- [CSPC Megalith Biopharmaceutical Co.,Ltd.](https://trialight.com/data/company/cspc-megalith-biopharmaceutical-co-ltd-3e23baf5-2c63-4924-bd71-93a2333b9a1f.md)

### Conditions (1)

- [Small cell lung carcinoma](https://trialight.com/data/condition/small-cell-lung-carcinoma-505ad14d-ce79-5398-b171-f724c32e1b4e.md) Primary condition

---

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