Starting soon
Phase 1/2
Phase I/II Study of SCTB39G in Advanced Solid Tumours
Condition(s) studied
Advanced Malignant Solid Tumor
Investigational drug(s) / intervention(s)
SCTB39G
SCTB39G: SCTB39G,IV
Study 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.
Eligibility
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.
Primary outcome measure(s)
- 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
Trial sites (1)
| Facility | City | Region | Status |
| Beijing Cancer Hospital |
Beijing |
Beijing Municipality |
|
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