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Trial Title:
Aims to Explore the Safety, Tolerability, and Preliminary Efficacy of SCTB14 in Adult Patients With Advanced Malignant Solid Tumours.
NCT ID:
NCT06304818
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:
SCTB14
Description:
SCTB14,IV
Arm group label:
SCTB14
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Start date:
April 30, 2024
Completion date:
December 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/NCT06304818