ClinicaliQ Trial Snapshot
- FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC — Recruiting • Phase I • Oncology • NCT06303505.
- What is being tested: TUB-040, a novel NaPi2b antibody-drug conjugate (ADC), is being investigated in a first-in-human trial to establish safety, tolerability, pharmacokinetics, and preliminary efficacy across dose escalation in patients with platinum-resistant ovarian cancer and recurrent/refractory adenocarcinoma NSCLC.
- Patient eligibility overview: The trial enrolls patients with either platinum-resistant ovarian cancer or recurrent/refractory adenocarcinoma non-small cell lung cancer; this represents heavily pre-treated populations with limited standard treatment options and poor prognosis.
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What This Trial Is Studying
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…
Eligibility Snapshot
- (for all patients) 1. Male or non-pregnant, non-breastfeeding female, age 18 years or older at the date of consent. 2. Disease not amenable to curative intent treatment. 3. 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. 4. Radiologically measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1, that includes at least 1 lesion not previously irradiated. 5. Eastern Cooperative Oncology Group (ECOG) 0-1. 6. Have a life expectancy of more than 12 weeks for disease-related mortality, as evaluated by the INV. 7. Patients must be willing to sign an archival tissue release form for research purposes and determination of biomarker (eg NaPi2b) expression. 8. 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. 9. Adequate organ function 10. Resolution of all acute toxic effects of prior therapy or surgical procedures to ≤grade 1 (except alopecia, hyperpigmentation, or discoloration (incl. vitiligo) of the skin and nails, stable immune-related toxicity such as hypothyroidism on hormone replacement, adrenal insufficiency on ≤10 mg daily prednisone [or…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.