FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTubulis GmbH
About this trial
The purpose of this multicentric, open label trial (NAPISTAR 1-01) is to evaluate the safety/tolerability, pharmacokinetics and preliminary efficacy of TUB-040 and to find the best dose of TUB-040 in patients with ovarian cancer and Non Small Cell Lung Cancer. TUB-040 is an antibody-drug-conjugate which delivers a topoisomerase I inhibitor to tumor cells which overexpress the target NaPi2b. The study consists of two parts: In dose escalation, ovarian cancer patients and lung cancer patients receive increasing doses of TUB-040 until the maximal tolerated dose is found. In dose optimization, at least two doses are compared with each other to determine which dose is optimal for patients.
TUB-040 is given IV every 3 weeks until the disease progresses or the patient has to stop due to side effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or non-pregnant, non-breastfeeding female, age 18 years or older at the date of consent.
Disease not amenable to curative intent treatment.
Patients have exhausted the standard of care treatment (SoC) with expected survival benefit and are not denied SoC with expected survival benefit by participating in the trial.
Radiologically measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, that includes at least 1 lesion not previously irradiated.
Disqualifiers
The patient is pregnant, lactating or breastfeeding or has a positive serum pregnancy test during the screening period.
History of hypersensitivity to exatecan or excipients of the TUB-040 formulation, including ADCs with deruxtecan, exatecan or camptothecan as a payload.
Disease that is refractory to topoisomerase-I inhibitors, defined as progression during or within 6 months of the last infusion.
Patients are not allowed to participate in interventional clinical studies either concurrently or within the previous 28 days or within 5 half-lives of any investigational pharmacologic agents or imaging materials, including dyes, investigational surgical techniques, or devices.
Trial design
Design model
Sequential
Treatments tested in this trial
TUB-040
DrugA complete treatment cycle is defined as 21 calendar days. TUB-040 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle
Treatment groups
250 Participants
are divided into 3 treatment groupsGroup A: Platinum resistant ovarian cancerExperimental treatment 1 intervention
Group B: Non small cell lung cancer-adenocarcinomaExperimental treatment 1 intervention
Group C: Platinum resistant ovarian cancer in combination with BevacizumabExperimental 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
Maximum plasma/serum concentration (Cmax)
The concentration of TUB-040 (conjugated ADC), total mAb, and free payload (Cmax will be derived).
Time frame
From enrollment until 30 days after last study drug2
Through plasma/serum concentration (Cmin)
The concentration of TUB-040 (conjugated ADC), total mAb, and free payload (Cmin will be derived).
Time frame
From enrollment until 30 days after last study drug3
The time taken to reach the maximum concentration (Tmax)
The concentration of TUB-040 (conjugated ADC), total mAb, and free payload (Tmax will be derived).
Time frame
From enrollment until 30 days after last study drug4
Area Under Curve (AUC)
The concentration of TUB-040 (conjugated ADC), total mAb, and free payload (AUC will be derived).
Time frame
From enrollment until 30 days after last study drugSponsors and contacts
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Source ClinicalTrials.gov