Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB14 in Adult Patients With Advanced Malignant Solid Tumours.

NCT06304818 | Not Yet Recruiting Phase 1

• 1 other identifier: SCTB14-X101
• Study Type: interventional
• Target: 515
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to explore the safety, tolerability, PK characteristics, immunogenicity, and preliminary anti-tumor efficacy of SCTB14 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 Tumours

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)

SCTB14

EXPERIMENTAL

SCTB14 of different doses,IV,every 3 weeks

Drug: SCTB14

Interventions

SCTB14 DRUG

SCTB14,IV

SCTB14

Eligibility Criteria

• Age: 18 Years - 75 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, 18 years old ≤ age ≤ 75 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;
• Adequate organ and bone marrow function.

You may not qualify if:

• Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;
• Other malignancies diagnosed within 5 years prior to the enrollment, except effectively treated malignant solid tumour (such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical cancer in situ, breast cancer in situ, etc.);
• History of hypertensive crisis or hypertensive encephalopathy; presence of uncontrolled hypertension. History of arterial thrombosis or deep vein thrombosis within 6 months prior to enrollmen;
• Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;
• Received chemotherapy, immunotherapy, biologic therapy, or other anti-tumor treatments within 4 weeks before enrollment;
• Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;
• Significant coagulopathy or other evident risk of bleeding;
• Major surgery or significant trauma within 4 weeks prior to enrollment; presence of unhealed skin wounds, surgical sites, trauma sites, severe mucosal ulcers, or fractures, or if the Investigator deems the participant unsuitable for the study;
• History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;
• History of severe allergies, severe drug allergies (including unapproved investigational drugs), or known allergy to any component of the IMP;
• History of organ transplantation or stem cell transplantation;
• Pregnant or breastfeeding female; women of childbearing potential with positive pregnancy test within 7 days before the enrollment; participants (including males of childbearing potential and their female partners, and females of childbearing potential and their male partners) unwilling to use medically recognized effective contraception during the study and for 6 months after treatment ends.

Sponsors & Collaborators

• Sinocelltech Ltd.: lead

Central Study Contacts

Ming Guo

CONTACT

+86-10-58628288-9138; ming_guo@sinocelltech.com

Study Design

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

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: April 30, 2024
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: March 15, 2024

Record last verified: 2024-03