Phase I/II Study of SCTB39G in Advanced Solid Tumours

Sinocelltech

Status and phase

Not yet enrolling

Phase 2

Phase 1

Conditions

Advanced Malignant Solid Tumor

Treatments

Drug: SCTB39G

Study type

Interventional

Funder types

Industry

Identifiers

NCT07077252

SCTB39G-X201

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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;
1. 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.