FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC

Inclusion Criteria

• •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 \[or equivalent\], chronic grade 2 peripheral sensory neuropathy after prior taxane therapy).
• •11. Patients of childbearing potential (FCBP) who are sexually active with a non-sterilized partner must use at least one highly effective method of contraception from the time of screening and must agree to continue using such precautions until the end of exposure, plus 5 half-lives and 6 months add-on in the case of patients assigned female at birth. Abstinence is acceptable only as true abstinence when this is in line with the preferred and usual lifestyle of the patient for the duration of the study treatment and the above-referred period after the end of the exposure. Periodic abstinence (e.g., calendar ovulation, symptothermal, post-ovulation methods), the rhythm method, and the withdrawal method are not acceptable methods of contraception.
• •12. In the opinion of the investigator, the patient must be able to understand, give written informed consent, and comply with all study-related procedures, medication use, and evaluations.
• •13. The patient must not have a history of non-compliance with medical regimens or be considered potentially unreliable and/or uncooperative.
• •14. The patient must be willing to sign and date the informed consent form (ICF)
• •3. HIV infected patients must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease
• •4. Any other known unresolved and active bacterial, viral, fungal, mycobacterial, or other infection at screening.
• •5. History of severe and recurrent infections per INV judgment.
• •6. History of progressive multifocal leukoencephalopathy