Phase I/II Study of SCTB39-1 in Advanced Solid Tumours
- Conditions
- Advanced Malignant Solid Tumor
- Interventions
- Drug: SCTB39-1
- Registration Number
- NCT07050641
- Lead Sponsor
- Sinocelltech Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 110
- Voluntarily sign the informed consent form (ICF);
- Male or female, over 18 years old;
- Survival duration more than 3 months;
- ECOG score ≤ 1 point;
- Participants in Phase Ia (dose-escalation phase) are required to meet the following criteria: histologically or cytologically confirmed diagnosis of advanced malignant solid tumour;
- 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;
- At least one measurable tumor lession according to RECIST v1.1;
- Adequate organ and bone marrow function.
- Has participated in another clinical study within 4 weeks prior to the first dose;
- Other malignancies diagnosed within 5 years prior to the enrollment;
- Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;
- Significant bleeding risk;
- Presence of pleural effusion, peritoneal effusion, or ascites;
- History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;
- Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;
- History of severe allergies, severe drug allergies (including unapproved investigational drugs);
- History of organ transplantation or stem cell transplantation;
- Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;
- Received chemotherapy, immunotherapy, biologic therapy, or other anti-tumor treatments within 4 weeks before enrollment;
- Pregnant or breastfeeding female.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description SCTB39-1 SCTB39-1 SCTB39-1 of different doses, IV, every 3 weeks
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
Trial Locations
- Locations (1)
Cancer Hospital Chinese Academy of Medical Science
🇨🇳Beijing, China
Cancer Hospital Chinese Academy of Medical Science🇨🇳Beijing, ChinaYu HuaContact+86-18810090438tsjj0082@chncro.com