Advanced Malignant Solid Tumor
Conditions
Keywords
Phase I/ II Study of SCTB39G in Advanced Solid Tumours
Brief summary
This study aims to evaluate the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB39G 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
DRUGSCTB39G
SCTB39G,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 70 Years
Healthy volunteers
No
Inclusion criteria
* 1.Voluntarily sign the informed consent form (ICF); * 2.Male or female, ≥ 18 years and ≤ 70 years old; * 3.Survival duration more than 3 months; * 4.ECOG score ≤ 1 point; * 5.histologically or cytologically confirmed diagnosis of advanced malignant solid tumour； * 6.At least one measurable tumor lession 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.Other malignancies diagnosed within 1 years prior to the enrollment; * 3\. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases; * 4.NSCLC at high risk of bleeding; Obvious invasion of tumor into adjacent organs of esophageal lesions leads to high risk of bleeding or fistula,or participants after endotracheal stent implantation; * 5.Participants with portal hypertension due to portal vein tumor thrombus at risk of bleeding; * 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 |
|---|---|---|
| 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 SCTB39G 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 SCTB39G until death due to any cause. |
Countries
China
Contacts
Primary ContactZhe Huang
Outcome results
None listed