NCT06657222

First in Human Study of TUB-030 in Patients With Advanced Solid Tumors

A Multicenter FIH Dose Escalation and Optimization Phase I/IIa Trial to Investigate Safety, Tolerability, PK, and Efficacy of the 5T4 ADC TUB-030 in Patients With Advanced Solid Tumors (5-STAR 1-01)

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Tubulis GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are: To determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer types and to determine the best dose. Participants will: Receive drug TUB-030 every 3 weeks Visit the clinic once every 3 weeks for checkups and tests Answer patient reported outcome questionnaires about their symptoms

Conditions

• Advanced Solid Tumors
• HNSCC
• SCLC
• NSCLC
• TNBC - Triple-Negative Breast Cancer
• CRC

Interventions

Type	Name	Description
DRUG	TUB-030	A complete treatment cycle is defined as 21 calendar days. TUB-030 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle

Timeline

• Start date: 2024-12-13
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2024-10-24
• Last updated: 2026-03-03

Locations

16 sites across 4 countries: United States, Canada, Romania, Spain

Regulatory

• FDA-regulated drug study