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

NCT06657222 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2026-03-03

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Tubulis GmbH

    lead INDUSTRY

Principal Investigators

  • Yariv Houvras, MD, PhD · Tubulis GmbH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-13
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Romania
  • Spain

Study Locations

More Related Trials

Entities

Diseases

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 NCT06657222 on ClinicalTrials.gov