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

Tubulis

Status and phase

Enrolling

Phase 2

Phase 1

Conditions

TNBC - Triple-Negative Breast Cancer

Advanced Solid Tumors

HNSCC

CRC

SCLC

NSCLC

Treatments

Drug: TUB-030

Study type

Interventional

Funder types

Industry

Identifiers

NCT06657222

5-STAR 1-01

Details and patient eligibility

About

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

Enrollment

130 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

130 participants in 2 patient groups

Phase 1: dose escalation

Experimental group

Description:

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

Treatment:

Drug: TUB-030

Phase 2: dose optimization in NSCLC and HNSCC

Experimental group

Description:

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

Treatment:

Drug: TUB-030

Trial contacts and locations

Central trial contact

Tubulis Clinical Trial Inquiries

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trials Trials by location

Research sites

Find research sites Learn about CTV for professionals

Resources

Contact CTV support

Legal

Privacy Notice Terms