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Clinical Trial of TB511 in Advanced Solid Tumors

NCT06400160 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-11-25

No results posted yet for this study

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).

Conditions

Interventions

DRUG

TB511

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.

DRUG

Keytruda

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.

Sponsors & Collaborators

  • Twinpig Biolab, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2027-03-31
Completion
2028-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06400160 on ClinicalTrials.gov