First in Human Study of TUB-030 in Patients With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTubulis GmbH
About this trial
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
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial design
Design model
Sequential
Treatments tested in this trial
TUB-030
DrugA 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
Treatment groups
250 Participants
are divided into 2 treatment groupsGroup A: Phase 1: dose escalationExperimental treatment 1 intervention
Group B: Phase 2: dose optimization in NSCLC and HNSCCExperimental treatment 1 intervention
Trial outcomes
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
Time frame
From enrollment until 30 days after last study drugSecondary outcomes
1
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 drug2
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 drug3
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 drug4
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 drugSponsors and contacts
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Source ClinicalTrials.gov