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

An Open Multi-center Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of SCTB39-1 in Adult Patients With Advanced Malignant Solid Tumours

This trial will try SCTB39-1 in adults with advanced malignant solid tumors to see if it is safe and can shrink or slow tumors.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sinocelltech Ltd. (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Beijing)
• Trial ID: NCT07050641 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (≥18) with histologically or cytologically confirmed advanced malignant solid tumors, ECOG performance status 0–1, at least one measurable lesion, expected survival >3 months, and adequate organ and marrow function are the intended participants.

Not a fit: Patients with active brainstem, meningeal, spinal metastases or compression, recent other malignancies, recent participation in another trial, or poor organ or marrow function are unlikely to benefit or be eligible.

Why it matters

Potential benefit: If successful, SCTB39-1 could provide a new treatment option that shrinks or slows tumor growth for some patients with advanced solid cancers.

How similar studies have performed: SCTB39-1 is an investigational agent with limited public data; similar early-phase oncology agents have sometimes produced promising responses but most remain experimental until confirmed in later-phase trials.

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 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 this trial is running

Beijing

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

Study contacts

• Study coordinator: Cuige Gao

Conditions Advanced Malignant Solid Tumor; advanced malignant solid tumor