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

NCT06970795 | Recruiting Phase 1

• 1 other identifier: SYS6040
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Small Cell Lung Cancer; Other Advanced Solid Tumors

Outcome Measures

Primary Outcomes (4)

• DLT（Phase 1a）

  Incidence rate and category of dose limiting toxicities (DLTs) during the first 21-day cycle of SYS6040 treatment

  Up to approximately 21days

• Frequency and severity of TEAE and SAE（Phase 1a）

  Assess safety and tolerability of SYS6040

  Up to approximately 2years

• RP2D (Phase 1a）

  RP2D was determined based on the safety, tolerability, PK, immunogenicity data and efficacy information obtained

  Up to approximately 2 years

• ORR（Phase 1b）

  Objective response rate (ORR) as evaluated by Investigator (RECIST1.1).

  Up to approximately 2 years

Secondary Outcomes (16)

• Peak time(Tmax)（phase 1a）

  Up to approximately 2 years

• Maximum plasma concentration (Cmax) （phase 1a）

  Up to approximately 2 years

• AUC 0-t（phase 1a）

  Up to approximately 2 years

• AUC 0-∞（phase 1a）

  Up to approximately 2 years

• Steady state peak concentration(Cmax,ss) （phase 1a）

  Up to approximately 2 years

Study Arms (1)

SYS6040 for injection as single agent

EXPERIMENTAL

Drug: SYS6040 for injection

Interventions

SYS6040 for injection DRUG

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)

SYS6040 for injection as single agent

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ）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.
• \) 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);
• Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min;
• 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.
• \) Understand and voluntarily sign the informed consent form (ICF).

You may not qualify if:

• 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);
• 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;

Sponsors & Collaborators

• CSPC Megalith Biopharmaceutical Co.,Ltd.: lead

Study Sites (1)

Jilin Cancer Hospital

Changchuan, Jilin, 130021, China

RECRUITING

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Injections

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 2, 2025
• First Posted: May 14, 2025
• Study Start: April 10, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): November 30, 2028
• Last Updated: May 14, 2025

Record last verified: 2025-04

Locations

CN (1)