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Trial Title:
Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB41 in Adult Patients With Advanced Malignant Solid Tumours.
NCT ID:
NCT06600022
Condition:
Advanced Malignant Solid Tumours
Conditions: Official terms:
Neoplasms
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SCTB41
Description:
SCTB41 of different doses,IV,every 3 weeks
Arm group label:
Arms
Summary:
This study aims to explore the safety, tolerability, PK characteristics, immunogenicity,
and preliminary anti-tumor efficacy of SCTB41 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Voluntarily sign the informed consent form (ICF);
2. Male or female, ≥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. Adequate organ and bone marrow function.
Exclusion Criteria:
1. Participants with brainstem, meningeal, spinal metastases, orcompression; active
central nervous system metastases;
2. Other malignancies diagnosed;
3. History of hypertensive crisis or hypertensive encephalopathy; presence of
uncontrolled hypertension. History of arterial thrombosis or deep veinthrombosis
within 6 months prior to enrollment;
4. Presence of any active autoimmune disease or a history of autoimmunedisease with an
expected recurrence;
5. Received chemotherapy, immunotherapy, biologic therapy, or other antitumor
treatments within 4 weeks before enrollment;
6. Need for immunosuppressive drugs within 2 weeks prior to enrollment oranticipated
during the study;
7. Significant coagulopathy or other evident risk of bleeding;
8. uncontrolled effusions in the serous cavities within 4 weeks before enrollment；
9. Major surgery or significant trauma within 4 weeks prior to enrollment;presence of
unhealed skin wounds, surgical sites, trauma sites, severe- Page 3 of 4 [DRAFT]
-mucosal ulcers, or fractures, or if the Investigator deems the
participantunsuitable for the study;
10. History of permanent discontinuation of immunotherapy due to immunerelated toxicity
or occurrence of ≥ Grade 3 irAEs;
11. Known severe allergy to similar antibody drugs;
12. Presence of active infection；
13. History of organ transplantation or stem cell transplantation;
14. Pregnant or breastfeeding female; women of childbearing potential withpositive
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
October 10, 2024
Completion date:
April 30, 2028
Lead sponsor:
Agency:
Sinocelltech Ltd.
Agency class:
Industry
Source:
Sinocelltech Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06600022
