Advanced Malignant Solid Tumors
Conditions
Brief summary
This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB41 in combination with SCTB39G with or without standard therapy in adult patients with advanced malignant solid tumors. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I/II clinical trial.
Interventions
DRUGSCTB41+SCTB39G
SCTB41 plus SCTB39G of different doses, IV, every 3 weeks
Sponsors
Sinocelltech Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Voluntarily sign the informed consent form (ICF); 2. Male or female, ≥ 18 years and ≤ 75 years old; 3. Survival duration more than 3 months; 4. ECOG score ≤ 1 point; 5. Histologically or cytologically confirmed diagnosis of advanced malignant solid tumor； 6. At least one measurable tumor lesion according to RECIST v1.1; 7. Adequate organ and bone marrow function.
Exclusion criteria
1. Has participated in another clinical study within 4 weeks prior to the first dose; 2. Has previously received other immunotherapies other than PD-(L)1 inhibitors； 3. Other malignancies diagnosed within 5 years prior to the enrollment; 4. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases; 5. Significant bleeding risk; 6. Presence of pleural effusion, peritoneal effusion, or ascites; 7. Received chemotherapy, immunotherapy, biologic therapy, or other antitumor treatments within 4 weeks before enrollment； 8. History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs; 9. Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence; 10. History of severe allergies, severe drug allergies (including unapproved investigational drugs); 11. History of organ transplantation or stem cell transplantation; 12. Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study; 13. Pregnant or breastfeeding female.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-Limiting Toxicity(DLT) | From Day 0 up to Day 21 | Incidence of dose-limiting toxicities up to the Day 21 visit |
| Objective Response Rate (ORR) | Up to 2 years | The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of adverse events (AEs) | Up to 2 years | To investigate the safety characteristics. |
| Disease Control Rate (DCR) | Up to 2 years | The DCR is defined as the proportion of subjects with CR, PR, or SD based on RECIST Version 1.1. |
| Progression-Free Survival (PFS) | Up to 2 years | The PFS is defined as the time from the start of treatment until the first documentation of disease progression or death due to any cause, whichever occurs first. |
| Overall Survival (OS) | Up to 2 years | Overall survival is defined as the time from the start of treatment until death due to any cause. |
Contacts
CONTACTZhe Huang
Outcome results
None listed