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

NCT07050641 | Recruiting Phase 1

• 1 other identifier: SCTB39-1-X201
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Malignant Solid Tumor

Keywords

advanced malignant solid tumor

Outcome Measures

Primary Outcomes (2)

• Dose-Limiting toxicity(DLT)

  Incidence of dose-limiting toxicities up to the Day 21 visit

  From Day 0 up to Day 21

• Objective response rate (ORR)

  The ORR is defined as the proportion of subjects with confirmed CR or confirmed PR, based on RECIST Version 1.1.

  Up to 2 years

Secondary Outcomes (3)

• Disease control rate (DCR)

  Up to 2 years

• Progression-free survival (PFS)

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

Study Arms (1)

SCTB39-1

EXPERIMENTAL

SCTB39-1 of different doses, IV, every 3 weeks

Drug: SCTB39-1

Interventions

SCTB39-1 DRUG

SCTB39-1, IV

SCTB39-1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Science

Beijing, China

RECRUITING

Central Study Contacts

Cuige Gao

CONTACT

+86-10-58628288; cuige_gao@sinocelltech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2025
• First Posted: July 3, 2025
• Study Start: June 23, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)