Phase I/II Study of SCTB39G 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: SCTB39G.
- Who it may be relevant to
- Registry conditions: Advanced Malignant Solid Tumor. Basic parameters: 18 years — 70 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 SCTB39G 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 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
- Drug SCTB39G
SCTB39G,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
- 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.
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
- Beijing Cancer Hospital — Beijing
Identifiers
NCT: NCT07077252 · SCTB39G-X201