SCTB39-1 for adults with advanced solid tumors (Phase 1/2 dose-escalation and expansion)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multicenter Phase 1/2 trial gives SCTB39-1 alone to adults with advanced malignant solid tumors using a dose-escalation phase to identify safe dosing followed by dose-expansion cohorts at selected doses. Investigators will collect safety, tolerability, pharmacokinetics, and immunogenicity data and will measure preliminary anti-tumor activity using RECIST v1.1. Eligible patients must be ≥18 years old with histologically or cytologically confirmed advanced tumors, at least one measurable lesion, ECOG 0-1, and adequate organ and bone marrow function. The trial excludes patients with active central nervous system metastases, recent other malignancies, recent participation in another clinical study, and other significant risks such as bleeding.

Why it matters

Who can join: the full rules

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.

Where it's running

• Cancer Hospital Chinese Academy of Medical Science
  Beijing, China Recruiting

Study contacts

• Study coordinator: Cuige Gao
• Email: cuige_gao@sinocelltech.com
• Phone: +86-10-58628288

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.