Clinical Trial of TB511 in Advanced Solid Tumors

Sponsor
Twinpig Biolab, Inc.
Study ID
NCT06400160
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TB511 — DRUG
    TB511 is a peptide drug conjugate (PDC) which composed of TAMpep826 peptide. TB511 is a white amorphous powder used for subcutaneous injections. TB511 is a peptide drug conjugate that combines a transporter peptide with a specific targeting of M2 macrophages and an apoptosis-inducing peptide (dKLA). As a transporter, the M2 binding peptide acts as a drug conjugate, explicitly binding to M2 macrophages and inducing cell penetration. In the cells, the dKLA component of TB511 binds to the mitochondrial membrane, destroys the mitochondrial membrane, and induces apoptosis by causing cytochrome release, leading to the destruction of the mitochondria and subsequent death of M2 macrophages.
  • Keytruda — DRUG
    KEYTRUDA binds to the PD - 1 receptor, blocking both immune-suppressing ligands, PD L1 and PD L2, from interacting with PD - 1 to help restore T-cell response and immune response.

Study Details

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).

Key Dates

Start date
Mar 31, 2026
Status verified
Nov 2025
Primary completion
Mar 31, 2027
Completion
Mar 31, 2028

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TB511
    * Product name or code: TB511 Injection (8 mg) * Formulation and appearance: White or off-white color of lyophilized powder ③ Main ingredient: TB511 ④ Storage method: Store in a hermetic container in a freezer (-20℃); protect from light
  • Other: Concomitant drug
    * Product name or code: Keytruda ② Formulation and appearance: An injection comprised of clear to slightly opalescent, colorless to slightly yellow liquid contained in a colorless and transparent vial. ③ Main ingredient: Pembrolizumab * Storage method: Store in a hermetic container, refrigerated at 2 to 8℃; protect from light; do not freeze

Primary Outcome Measure

Phase I Clinical trial-Maximum tolerated dose (MTD). [ Time Frame: 1 year ]

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