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

Description

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

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Study Overview

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Study Details

Study overview

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

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)

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

Condition
Advanced Solid Tumors
Intervention / Treatment

-

Contacts and Locations

Austin

NEXT Oncology Austin, Austin, Texas, United States, 78758

Irving

NEXT Oncology - Dallas, Irving, Texas, United States, 75039

San Antonio

NEXT Oncology - San Antonio, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Male or non-pregnant, non-breastfeeding female aged 18 years or older
  • 2. Adequate organ function
  • 3. Patients who received anti-cancer treatment including chemotherapy, biological therapy, endocrine therapy, PARP inhibitor, or other oral or investigational drugs must have had their last dose at least 4 weeks (6 weeks for nitrosourea, mitomycin-C) or 5 half-lives, whichever is shorter, before C1D1
  • 4. AEs related to prior therapy, radiotherapy or surgical procedures must resolve to ≤grade 1.
  • 5. For patients with known brain metastases, evidence of clinically stable disease post radiation therapy is required prior to enrollment.
  • 6. For patients who underwent radiotherapy (≥ 30% of the bone marrow or wide field) to sites outside the brain, the final dose of radiation must have been administered ≥ 28 days prior to C1D1. For patients who underwent palliative radiotherapy (≤ 30% of the bone marrow or wide field) the final dose of radiation must have been administered ≥14 days prior to C1D1.
  • 7. Radiologically measurable disease by RECIST v1.1, 4 weeks before C1D1, that can include a lesion in an irradiated field that shows progression according to RECIST v1.1 after irradiation.
  • 8. Eastern Cooperative Oncology Group (ECOG) 0-1.
  • 9. Have a life expectancy of \>12 weeks for disease-related mortality, as evaluated by the INV.
  • 10. In the opinion of the INV, the patient must be able and willing to understand and give signed informed consent
  • 11. Women of childbearing potential (WOCBP) who are sexually active with a non-sterilized partner must use at least 1 highly effective method of contraception (with a failure rate of 1% per year) from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of patients of childbearing potential Patients must agree to continue a highly effective contraceptive method, refrain from egg cell donation and breastfeeding while on study treatment and for 5 half-lives plus 6 months after the last dose of study treatment.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Tubulis GmbH,

Gunter Fingerle-Rowson, MD, PhD, STUDY_DIRECTOR, Tubulis GmbH

Study Record Dates

2028-12