Clinical Trial of TB511 in Advanced Solid Tumors
Summary
1. Study population \[TB511 Monotherapy Cohort for Phase 1 and Phase 2a Clinical Trial\] Patients with advanced solid tumors who are either refractory or intolerant to standard of care (SoC). \[Immune checkpoint inhibitors (ICIs) Combination Therapy Cohort for Phase 2a Clinical Trial\] Patients with advanced solid tumors who are refractory to immune checkpoint inhibitors (ICIs) such as anti-PD-1, anti-PD-L1, or anti-CTLA-4 inhibitors or who have no available standard of care. 2. Objectives of the Clinical Trial 2.1 Primary Objectives \[Phase 1 Clinical Trial\] * To evaluate the safety and tolerability of TB511 monotherapy in patients with advanced solid tumors and to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase II Dose (RP2D). \[Phase 2a Clinical Trial\] * To evaluate the Objective Response Rate (ORR) of TB511 monotherapy and TB511 in combination with Pembrolizumab in patients with advanced solid tumors (based on Response Evaluation Criteria In Solid Tumors Version 1.1, RECIST v1.1). 2.2 Secondary Objectives \[Phase 1 Clinical Trial\] * To evaluate the safety of TB511 monotherapy. * To assess the Objective Response Rate (ORR) and anti-tumor activity of TB511 monotherapy (based on RECIST v1.1). * To characterize the pharmacokinetic (PK) profile of TB511 monotherapy. \[Phase 2a Clinical Trial\] * To evaluate the Disease Control Rate (DCR), Duration of Response (DoR), and Progression-Free Survival (PFS) of TB511 monotherapy and TB511 in combination with Pembrolizumab. * To assess the safety and tolerability of TB511 monotherapy and TB511 in combination with Pembrolizumab. * To characterize the pharmacokinetic (PK) profile of TB511 monotherapy and TB511 in combination with Pembrolizumab. 2.3 Exploratory Objectives * To compare changes in biomarker levels of TB511 monotherapy. * To assess immunogenicity of TB511 by measuring anti-drug antibodies (ADA).
Timeline
- Start
- 2026-03
- Primary completion
- 2027-03
- Completion
- 2028-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TB511 | Peptide | 4 mg | Subcutaneous |
| Subject | TB511 | Peptide | 8 mg | Subcutaneous |
| Subject | TB511 | Peptide | 12 mg | Subcutaneous |
| Subject | TB511 | Peptide | 16 mg | Subcutaneous |
| Subject | TB511 | Peptide | 20 mg | Subcutaneous |
| Subject | TB511 | Peptide | 24 mg | Subcutaneous |
| Background | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |