Solid Tumors
Conditions
Interventions
Phase I Dose Group 1:1mcg/kg, Q2W
Phase I Dose Group 2:3mcg/kg, Q2W
Phase I Dose Group 3:10mcg/kg, Q2W
Phase I Dose Group 4:20mcg/kg, Q2W
Phase I Dose Group 5:30mcg/kg, Q2W
Phase I Dose Group 6:30mcg/kg, Q3W
Phase I Dose Group 7:30mcg/kg, Q3W
Phase I Dose Group 8:N-3C01 20 mcg/kg,Q3W + PD-(L)1, Fixed Dose
Phase I Dose Group 9:N-3C01 30 mcg/kg,Q3W + PD-(L)1, Fixed Dose
Phase II Cohort 1 NSCLC:N-3C01 RP2D+PD-(L)1
Phase II Cohort 2 Melanoma:N-3C01 RP2D+PD-(L)1
Phase II Other Tumor Types:N-3C01 RP2D+PD-(L)1
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in the trial and sign the informed consent form; 2. Aged 18-75 years (inclusive) at the time of signing the informed consent form, regardless of gender; 3. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1 (Appendix 1); 4. Expected survival time >=3 months; 5. Phase I: Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors, who have progressed after prior standard systemic therapy, have no available standard of care, be intolerable to standard of care, or have standard of care deemed inappropriate by the Investigator; Phase II: Cohort 1: Advanced NSCLC progressed after immune checkpoint inhibitor therapy (monotherapy or in combination with chemotherapy); Cohort 2: Advanced melanoma progressed after chemotherapy and/or immune checkpoint inhibitor therapy; Others: Tumor types including colorectal cancer, renal cell carcinoma, head and neck squamous cell carcinoma, endometrial cancer, ovarian cancer, etc., progressed after chemotherapy and/or immune checkpoint inhibitor therapy, deemed potentially beneficial by the Investigator. 6. Have at least one measurable lesion according to RECIST version 1.1 (except for participants in monotherapy dose escalation study); 7. Have adequate organ function 8. Use contraception during the study treatment period and for 3 months after the end of study treatment; female participants or female partners of male participants should use highly effective contraceptive methods; non-surgically sterilized female participants of childbearing potential must have a negative serum HCG test within 1 week prior to the first dose and must be non-lactating.
Exclusion criteria
Exclusion criteria: 1. Have unstable central nervous system metastases or concurrent intracranial primary tumors requiring intervention (except if the patient is asymptomatic, radiologically stable for 4 weeks prior to the first study dose, and does not require corticosteroid therapy or seizure prophylaxis); 2. Patients with two or more malignant tumors, with the exception of carcinoma in situ of the cervix, carcinoma in situ of the breast, basal cell or squamous cell carcinoma of the skin, and papillary thyroid carcinoma that are well-controlled and have no evidence of disease recurrence within prior 2 years; 3. Have uncontrolled tumor-related pain; participants requiring analgesic medication must have a stable analgesic regimen upon study entry; 4. Have uncontrolled pleural effusion, pericardial effusion, or ascites (not excluded if drainage is not required, or if effusion does not significantly increase within 3 days after drainage); 5. Have idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of clinically active pneumonitis at Screening; participants with a history of radiation pneumonitis (fibrosis) in the radiation field may participate in this study. 6. History of autoimmune diseases (the following are not excluded: well-controlled type I diabetes mellitus; hypothyroidism well-controlled only with hormon replacement therapy; skin diseases not requiring systemic therapy, such as eczema, psoriasis, chronic simple lichen, vitiligo, alopecia; well-controlled celiac disease); 7. Have received systemic corticosteroid therapy within 1 week prior to the first study dose or other systemic immunosuppressive therapy within 2 weeks (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, etc.), except for physiological replacement doses of prednisone =10 mg/day or equivalent; 8. History of clinically significant cardiovascular diseases, including but not limited to: (1) Congestive heart failure (NYHA class >2); (2) Unstable angina; (3) Myocardial infarction within the past 3 months; (4) Any supraventricular or ventricular arrhythmia requiring treatment or intervention; 9. History of clinically significant bleeding symptoms within 3 months prior to the first study dose. Participants with significant hemoptysis (coughing bright red blood, with each episode reaching half a teaspoon [2.5 mL] or more) within 1 month prior to the first study drug administration cannot be enrolled; 10. Arterial/venous thrombotic events within 6 months prior to the first study dose, such as cerebrovascular accident, deep vein thrombosis, and pulmonary embolism; 11. Active tuberculosis infection identified by medical history or computed tomography (CT) scan within 1 year prior to enrollment, or have a history of active tuberculosis infection more than 1 year ago without formal treatment; 12. Severe infection within 4 weeks prior to the first study dose, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc.; active infection requiring systemic antibiotic therapy of National Cancer Institute Common Terminology Criteria for Adverse Events Version 6.0 (CTCAE v6.0) grade =2 within 2 weeks prior to the first dose; 13. History of immunodeficiency; 14. Have active hepatitis B (HBsAg or HBeAg positive and HBV DNA =500 IU/mL), hepatitis C (positive HCV antibody and HCV RNA above the lower limit of detection of the assay), p
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I Dose Escalation Study: Safety;Phase I Dose Escalation Study: Tolerability;Phase I Dose Escalation Study: MTD;Phase I Dose Escalation Study: R2PD;Phase II Cohort Expansion Study: Efficacy (Objective Response Rate [ORR]);Phase II Cohort Expansion Study: Efficacy (Disease Control Rate [DCR]);Phase II Cohort Expansion Study: Efficacy (Progression-Free Survival [PFS]); | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I Dose Escalation Study: PK;Phase I Dose Escalation Study: Immunogenicity;Phase I Dose Escalation Study: Preliminary Efficacy (Objective Response Rate [ORR]) ;Phase I Dose Escalation Study: Preliminary Efficacy (Disease Control Rate [DCR]) ;Phase I Dose Escalation Study: Preliminary Efficacy (Progression-Free Survival [PFS]) ;Phase II Cohort Expansion Study: Safety;Phase II Cohort Expansion Study: PK;Phase II Cohort Expansion Study: Immunogenicity; | — |
Countries
China
Contacts
Public ContactZhou Caicun
Shanghai East Hospital
Outcome results
None listed