FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC … (NCT06303505) | Clinical Trial Compass
RecruitingPhase 1/2
FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC
United States250 participantsStarted 2024-06-12
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Eastern Cooperative Oncology Group (ECOG) 0-1.
✓. Have a life expectancy of more than 12 weeks for disease-related mortality, as evaluated by the INV.
✓. Patients must be willing to sign an archival tissue release form for research purposes and determination of biomarker (eg NaPi2b) expression.
✓. Patients must be willing to undergo a non-contrast high resolution computed tomography (HRCT) of the thorax scan and pulmonary function testing (PFT) at screening.
Exclusion criteria
What they're measuring
1
Determination of MTD
Timeframe: From enrollment until 30 days after last study drug
✕. 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.
✕. Patients with spinal cord compression or active central nervous system disease.
✕. Prior radiotherapy \<2 weeks from trial inclusion.
✕. Major surgery within 21 days prior to signing the ICF, unless the patient is recovered at that time.
✕. Has a history of non-infectious ILD/pneumonitis/radiation pneumonitis that required steroids or has current ILD/pneumonitis.