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

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

NCT ID: NCT06657222

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

Conditions: Official terms:
Triple Negative Breast Neoplasms

Conditions: Keywords:
Advanced Solid Tumors
NSCLC
Head and Neck Cancer

Study type: Interventional

Study phase: Phase 1/Phase 2

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Sequential Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: TUB-030
Description: 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
Arm group label: Phase 1: dose escalation
Arm group label: Phase 2: dose optimization in NSCLC and HNSCC

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

Criteria for eligibility:
Criteria:
Inclusion 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. Exclusion Criteria: -

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: NEXT Oncology Austin

Address:
City: Austin
Zip: 78758
Country: United States

Facility:
Name: NEXT Oncology - Dallas

Address:
City: Irving
Zip: 75039
Country: United States

Facility:
Name: NEXT Oncology - San Antonio

Address:
City: San Antonio
Zip: 78229
Country: United States

Start date: December 2024

Completion date: December 2028

Lead sponsor:
Agency: Tubulis GmbH
Agency class: Industry

Source: Tubulis GmbH

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06657222