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

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)

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

Study Overview

• Status: Recruiting
• Conditions: NSCLC; Advanced Solid Tumors; SCLC; CRC; HNSCC; TNBC - Triple-Negative Breast Cancer
• Intervention / Treatment: Drug: TUB-030

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Tubulis Clinical Trial Inquiries; Phone Number: +491758005594; Email: ct-inquiries@tubulis.com

Study Locations

• Canada
  • Toronto, Canada
    • Recruiting
    • Princess Margaret
• France
  • Paris, France, 75005
    • Recruiting
    • Institut Curie
  • Villejuif, France, 94805
    • Not yet recruiting
    • Institut Gustave Roussy
• Romania
  • Bucharest, Romania
    • Recruiting
    • ARENSIA Exploratory Medicine
  • Cluj-Napoca, Romania
    • Recruiting
    • ARENSIA Exploratory Medicine
• Spain
  • Barcelona, Spain
    • Recruiting
    • Hospital Clinic Barcelona
  • Madrid, Spain
    • Recruiting
    • Clinica Uni de Navara
• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Recruiting
      • Yale Cancer Center
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • University of Miami
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana Farber Cancer Institute
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Recruiting
      • Mayo Clinic
  • Missouri
    • St Louis, Missouri, United States, 63130
      • Recruiting
      • Washington University
  • New York
    • New York, New York, United States, 11766
      • Recruiting
      • Mount Sinai
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Recruiting
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University
  • Texas
    • Austin, Texas, United States, 78758
      • Recruiting
      • NEXT Oncology Austin
    • Irving, Texas, United States, 75039
      • Recruiting
      • NEXT Oncology - Dallas
    • San Antonio, Texas, United States, 78229
      • Recruiting
      • NEXT Oncology - San Antonio
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutchinson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.
12. 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.

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1: dose escalation; Drug TUB-030, administered by intravenous (IV) infusion	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
Experimental: Phase 2: dose optimization in NSCLC and HNSCC; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients with Adverse Events (AE)	Any medical event in a participant which may or may not have a causal relationship with this treatment.	From enrollment until 30 days after last study drug
Maximum concentration (Cmax)	The concentration of TUB-030 (conjugated ADC), total mAb, and free payload (Cmax will be derived).	From enrollment until 30 days after last study drug
Trough concentration (Cmin)	The concentration of TUB-030 (conjugated ADC), total mAb, and free payload (Cmin will be derived).	From enrollment until 30 days after last study drug
The time taken to reach the maximum concentration (Tmax)	The concentration of TUB-030 (conjugated ADC), total mAb, and free payload (Tmax will be derived).	From enrollment until 30 days after last study drug
Area Under Curve (AUC)	PK endpoint	From enrollment until 30 days after last study drug
Half life (T1/2)	PK endpoint	From enrollment until 30 days after last study drug
Determination of immunogenicity	Number and percentage of patients developing anti-TUB-030 antibodies	From enrollment until 30 days after last study drug
Determination of efficacy	ORR by investigator assest Recist 1.1	From enrolment until 30 days after last study drug.

Collaborators and Investigators

• Sponsor: Tubulis GmbH
• Investigators: Study Director: Yariv Houvras, MD, PhD, Tubulis GmbH

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): September 11, 2026
• Last Update Submitted That Met QC Criteria: September 10, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Head and Neck Cancer; NSCLC; Advanced Solid Tumors
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Skin Diseases; Breast Diseases; Carcinoma; Carcinoma, Squamous Cell; Breast Neoplasms; Skin and Connective Tissue Diseases; Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms; Triple Negative Breast Neoplasms
• Other Study ID Numbers: 5-STAR 1-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: we first want to evaluate the ICMJE Guidelines

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No