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Phase I/II Study of SCTB39-1 in Advanced Solid Tumours

Not Applicable
Recruiting
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
Inclusion Criteria
  1. Voluntarily sign the informed consent form (ICF);
  2. Male or female, over 18 years old;
  3. Survival duration more than 3 months;
  4. ECOG score ≤ 1 point;
  5. Participants in Phase Ia (dose-escalation phase) are required to meet the following criteria: histologically or cytologically confirmed diagnosis of advanced malignant solid tumour;
  6. 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;
  7. At least one measurable tumor lession according to RECIST v1.1;
  8. 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 5 years prior to the enrollment;
  3. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;
  4. Significant bleeding risk;
  5. Presence of pleural effusion, peritoneal effusion, or ascites;
  6. History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;
  7. Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;
  8. History of severe allergies, severe drug allergies (including unapproved investigational drugs);
  9. History of organ transplantation or stem cell transplantation;
  10. Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;
  11. Received chemotherapy, immunotherapy, biologic therapy, or other anti-tumor treatments within 4 weeks before enrollment;
  12. Pregnant or breastfeeding female.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
SCTB39-1SCTB39-1SCTB39-1 of different doses, IV, every 3 weeks
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
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, China
Yu Hua
Contact
+86-18810090438
tsjj0082@chncro.com
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