Clinical trial NCT06657222: First in Human Study of TUB-030 in Patients With Advanced Solid Tumors
Official title: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Advanced Solid Tumors
HNSCC
SCLC
NSCLC
TNBC - Triple-Negative Breast Cancer
CRC
Keywords: Advanced Solid Tumors
NSCLC
Head and Neck Cancer
Lead sponsor: Tubulis GmbH
Sponsor class: INDUSTRY
First posted: 2024-10-24
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


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:

-

Primary outcomes:
measure: Determination of MTD
timeFrame: From enrollment until 30 days after last study drug
Secondary outcomes:
measure: Number of patients with Adverse Events (AE)
timeFrame: From enrollment until 30 days after last study drug
measure: Maximum concentration (Cmax)
timeFrame: From enrollment until 30 days after last study drug
measure: Trough concentration (Cmin)
timeFrame: From enrollment until 30 days after last study drug
measure: The time taken to reach the maximum concentration (Tmax)
timeFrame: From enrollment until 30 days after last study drug
measure: Area Under Curve (AUC)
timeFrame: From enrollment until 30 days after last study drug
measure: Half life (T1/2)
timeFrame: From enrollment until 30 days after last study drug
measure: Determination of immunogenicity
timeFrame: From enrollment until 30 days after last study drug
measure: Determination of efficacy
timeFrame: From enrolment until 30 days after last study drug.
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: St. Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Mount Sinai
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Austin
country: United States
facility: NEXT Oncology Austin
state: Texas
city: Irving
country: United States
facility: NEXT Oncology - Dallas
state: Texas
city: San Antonio
country: United States
facility: NEXT Oncology - San Antonio
state: Texas
city: Toronto
country: Canada
facility: Princess Margaret
Study officials:
affiliation: Tubulis GmbH
name: Gunter Fingerle-Rowson, MD, PhD
role: STUDY_DIRECTOR
References: