Phase I/II Study of SCTB39-1 in Advanced Solid Tumours
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SCTB39-1.
- Who it may be relevant to
- Registry conditions: Advanced Malignant Solid Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open Multi-center Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCTB39-1 in Adult Patients With Advanced Malignant Solid Tumours
Overview
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
- Drug SCTB39-1
SCTB39-1, IV
Primary outcome measures
- Dose-Limiting toxicity(DLT) [Time frame: From Day 0 up to Day 21]
- Objective response rate (ORR) [Time frame: Up to 2 years]
Secondary outcome measures (3)
- Disease control rate (DCR) [Time frame: Up to 2 years]
- Progression-free survival (PFS) [Time frame: Up to 2 years]
- Overall survival (OS) [Time frame: Up to 2 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Cancer Hospital Chinese Academy of Medical Science — Beijing
Identifiers
NCT: NCT07050641 · SCTB39-1-X201