Phase I/II Study of SCTB39-1 in Advanced Solid Tumours
Recruiting
Phase 1Phase 2Interventional Study
Advanced Malignant Solid Tumor
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
110 (estimated)
Sponsor
Sinocelltech Ltd. · Industry
Who this trial is looking for
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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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Voluntarily sign the informed consent form (ICF);
2. Male or female, over 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 cytolog…
Inclusion Criteria:
1. Voluntarily sign the informed consent form (ICF);
2. Male or female, over 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. At least one measurable tumor lession according to RECIST v1.1;
8. Adequate organ and bone marrow function.
Exclusion Criteria:
1. Has participated in another clinical study within 4 weeks prior to the first dose;
2. Other malignancies diagnosed within 5 years prior to the enrollment;
3. Participants with brainstem, meningeal, spinal metastases, or compression; active central nervous system metastases;
4. Significant bleeding risk;
5. Presence of pleural effusion, peritoneal effusion, or ascites;
6. History of permanent discontinuation of immunotherapy due to immune-related toxicity or occurrence of ≥ Grade 3 irAEs;
7. Presence of any active autoimmune disease or a history of autoimmune disease with an expected recurrence;
8. History of severe allergies, severe drug allergies (including unapproved investigational drugs);
9. History of organ transplantation or stem cell transplantation;
10. Need for immunosuppressive drugs within 2 weeks prior to enrollment or anticipated during the study;
11. Received chemotherapy, immunotherapy, biologic therapy, or other anti-tumor treatments within 4 weeks before enrollment;
12. Pregnant or breastfeeding female.
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