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

Phase 1

Not yet recruiting

• Conditions: Advanced Malignant Solid Tumours
• Interventions: Drug: SCTB14

• Registration Number: NCT06304818
• Lead Sponsor: Sinocelltech Ltd.

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-05
• Study First Posted: 2024-03-12
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15
• Study Start: 2024-04-30
• Primary Completion: 2027-12-30
• Study Completion: 2028-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 515

Inclusion Criteria

1. Voluntarily sign the informed consent form (ICF);
2. Male or female, 18 years old ≤ age ≤ 75 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. Adequate organ and bone marrow function.

Exclusion Criteria

1. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;
2. 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.);
3. 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;
4. Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;
5. Received chemotherapy, immunotherapy, biologic therapy, or other anti-tumor treatments within 4 weeks before enrollment;
6. Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;
7. Significant coagulopathy or other evident risk of bleeding;
8. 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;
9. History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;
10. History of severe allergies, severe drug allergies (including unapproved investigational drugs), or known allergy to any component of the IMP;
11. History of organ transplantation or stem cell transplantation;
12. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SCTB14	SCTB14	SCTB14 of different doses,IV,every 3 weeks

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Progression-free survival (PFS)	Up to 2 years	Progression-free survival is defined as the time from the start of treatment with SCTB14 until the first documentation of disease progression or death due to any cause, whichever occurs first.
Overall survival (OS)	Up to 2 years	Overall survival is defined as the time from the start of treatment with SCTB14 until death due to any cause.