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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
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
Yale Cancer Center
New Haven, Connecticut, United States
RECRUITINGUniversity of Miami
Miami, Florida, United States
RECRUITINGMassachusetts General Hospital
Boston, Massachusetts, United States
RECRUITINGDana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGMayo Clinic
Rochester, Minnesota, United States
RECRUITINGWashington University
St Louis, Missouri, United States
RECRUITINGMount Sinai
New York, New York, United States
RECRUITINGCleveland Clinic
Cleveland, Ohio, United States
RECRUITINGOhio State University
Columbus, Ohio, United States
RECRUITINGNEXT Oncology Austin
Austin, Texas, United States
RECRUITING...and 10 more locations
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
Time frame: From enrollment until 30 days after last study drug
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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: From enrollment until 30 days after last study drug
Area Under Curve (AUC)
PK endpoint
Time frame: From enrollment until 30 days after last study drug
Half life (T1/2)
PK endpoint
Time frame: From enrollment until 30 days after last study drug
Determination of immunogenicity
Number and percentage of patients developing anti-TUB-030 antibodies
Time frame: From enrollment until 30 days after last study drug
Determination of efficacy
ORR by investigator assest Recist 1.1
Time frame: From enrolment until 30 days after last study drug.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.