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

NCT06657222 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 5-STAR 1-01
• Study Type: interventional
• Target: 250
• Locations: 4 countries
• Sites: 16

Brief 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

Keywords

Advanced Solid Tumors; NSCLC; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Determination of MTD

  The highest dose is defined at which no more than 1 of 3 patients have had a Dose Limiting Toxicity (DLT) according to NCI CTCAE V5.0 criteria

  From enrollment until 30 days after last study drug

Secondary Outcomes (8)

• Number of patients with Adverse Events (AE)

  From enrollment until 30 days after last study drug

• Maximum concentration (Cmax)

  From enrollment until 30 days after last study drug

• Trough concentration (Cmin)

  From enrollment until 30 days after last study drug

• The time taken to reach the maximum concentration (Tmax)

  From enrollment until 30 days after last study drug

• Area Under Curve (AUC)

  From enrollment until 30 days after last study drug

Study Arms (2)

Phase 1: dose escalation

EXPERIMENTAL

Drug TUB-030, administered by intravenous (IV) infusion

Drug: TUB-030

Phase 2: dose optimization in NSCLC and HNSCC

EXPERIMENTAL

Drug TUB-030, administered by intravenous (IV) infusion NSCLC Cohort: Patients will be randomized to receive one of two doses administered by IV infusion HNSCC Cohort: Patients will be randomized to receive one of two doses administered by IV infusion

Drug: TUB-030

Interventions

TUB-030 DRUG

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

Phase 1: dose escalation; Phase 2: dose optimization in NSCLC and HNSCC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant, non-breastfeeding female aged 18 years or older
• Adequate organ function
• 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
• AEs related to prior therapy, radiotherapy or surgical procedures must resolve to ≤grade 1.
• For patients with known brain metastases, evidence of clinically stable disease post radiation therapy is required prior to enrollment.
• 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.
• 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.
• Eastern Cooperative Oncology Group (ECOG) 0-1.
• Have a life expectancy of \>12 weeks for disease-related mortality, as evaluated by the INV.
• In the opinion of the INV, the patient must be able and willing to understand and give signed informed consent
• 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.
• Males must use an effective barrier method of contraception without interruption if the patient is sexually active with an WOCBP until the end of exposure, 5 half-lives plus 6 months add-on after the end of treatment. In addition, their female partners who are WOCBP should agree to use 1 highly effective barrier method of contraception at the same time. Male patients should refrain from donating sperm during study participation and for 6 months after the last dose of the study drug.

Sponsors & Collaborators

• Tubulis GmbH: lead

Study Sites (16)

Yale Cancer Center

New Haven, Connecticut, 06510, United States

RECRUITING

University of Miami

Miami, Florida, 33136, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Mayo Clinic

Rochester, Minnesota, 55905, United States

RECRUITING

Washington University

St Louis, Missouri, 63130, United States

RECRUITING

Mount Sinai

New York, New York, 11766, United States

RECRUITING

Cleveland Clinic

Cleveland, Ohio, 44195, United States

RECRUITING

Ohio State University

Columbus, Ohio, 43210, United States

RECRUITING

NEXT Oncology Austin

Austin, Texas, 78758, United States

RECRUITING

NEXT Oncology - Dallas

Irving, Texas, 75039, United States

RECRUITING

NEXT Oncology - San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, 98109, United States

RECRUITING

Princess Margaret

Toronto, Canada

RECRUITING

Arensia Exploratory Medicine

Bucharest, Romania

RECRUITING

Arensia Exploratory Medicine

Cluj-Napoca, Romania

RECRUITING

Clinica Uni de Navara

Madrid, Spain

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Triple Negative Breast Neoplasms; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Breast Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yariv Houvras, MD, PhD

  Tubulis GmbH

  STUDY DIRECTOR

Central Study Contacts

Tubulis Clinical Trial Inquiries

CONTACT

+491758005594; ct-inquiries@tubulis.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: October 24, 2024
• Study Start: December 13, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (12); CA (1); RO (2); ES (1)