Advanced Malignant Solid Tumor
Conditions
Keywords
advanced malignant solid tumor
Brief summary
This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB39-1 as a monotherapy in adult patients with advanced malignant solid tumours. This study is an open label, multicentre, dose-escalation and dose-expansion Phase I/II clinical trial.
Interventions
DRUGSCTB39-1
SCTB39-1, IV
Sponsors
Sinocelltech Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Voluntarily sign the informed consent form (ICF); 2. Male or female, over 18 years old; 3. Survival duration more than 3 months; 4. ECOG score ≤ 1 point; 5. Participants in Phase Ia (dose-escalation phase) are required to meet the following criteria: histologically or cytologically confirmed diagnosis of advanced malignant solid tumour; 6. Participants in Phase Ib (dose-expansion phase) and Phase II are required to meet the following criteria: Histologically or cytologically confirmed specific type advanced malignant solid tumours; 7. At least one measurable tumor lession according to RECIST v1.1; 8. Adequate organ and bone marrow function.
Exclusion criteria
1. Has participated in another clinical study within 4 weeks prior to the first dose; 2. Other malignancies diagnosed within 5 years prior to the enrollment; 3. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases; 4. Significant bleeding risk; 5. Presence of pleural effusion, peritoneal effusion, or ascites; 6. History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs; 7. Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence; 8. History of severe allergies, severe drug allergies (including unapproved investigational drugs); 9. History of organ transplantation or stem cell transplantation; 10. Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study; 11. Received chemotherapy, immunotherapy, biologic therapy, or other anti-tumor treatments within 4 weeks before enrollment; 12. Pregnant or breastfeeding female.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Dose-Limiting toxicity(DLT) | From Day 0 up to Day 21 | Incidence of dose-limiting toxicities up to the Day 21 visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Progression-free survival is defined as the time from the start of treatment with SCTB39-1 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 with SCTB39-1 until death due to any cause. |
Countries
China
Contacts
Primary ContactCuige Gao
Outcome results
None listed