First Human Study of TUB-030 for Patients with Advanced Solid Tumors

Sponsor: Tubulis GmbH

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06657222

Provider View

This clinical trial is testing a new drug, TUB-030, to see if it can help treat solid tumors in adults. The study will also check how safe the drug is and find the best dose for patients.

Patient Parameters

Program Overview

The purpose of this study is to find out if the new drug TUB-030 can effectively treat solid tumors in adults and to ensure it is safe to use. Researchers want to determine the safest dose of TUB-030 when given alone to patients with solid tumors. They will also compare how well TUB-030 works in two specific types of cancer: head and neck cancer, and non-small cell lung cancer, to find the best dose for these conditions. Participants in the study will receive the drug TUB-030 every three weeks, visit the clinic for checkups and tests, and complete questionnaires about their symptoms.

Eligibility Criteria

Inclusion Criteria

  • Must be a male or a non-pregnant, non-breastfeeding female aged 18 or older.
  • Must have good organ function.
  • If previously treated with anti-cancer therapies, the last dose must have been at least 4 weeks ago (or 6 weeks for certain drugs) before starting the study.
  • Any side effects from previous treatments must be mild or resolved.
  • If there are known brain metastases, they must be stable after radiation therapy before joining the study.
  • If radiation therapy was received to areas outside the brain, the last dose must have been given at least 28 days ago (or 14 days for smaller areas) before starting the study.
  • Must have measurable disease by specific criteria, even if it includes a lesion in a previously treated area that has shown progression.
  • Must have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Must have a life expectancy of more than 12 weeks.
  • Must be able to understand and sign an informed consent form.
  • Women of childbearing potential must use effective contraception and agree to continue using it during the study and for a specified time after the last dose.

Exclusion Criteria

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