Ovarian Cancer study: TUB-040 vs Bevacizumab
Official title FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC
ClinicalTrials.gov ID: NCT06303505
What this study is testing
What is TUB-040?
TUB-040 is an investigational intravenous medicine being studied as a potential treatment for ovarian cancer.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to find out how safe TUB‑040 is, how it moves through the body, and if it shows early signs of helping people with ovarian or non‑small cell lung cancer.
- Who it's for
- It is looking for adults who have ovarian cancer or non‑small cell lung cancer and can receive an IV treatment.
- What's involved
- Participants will receive TUB‑040 by IV injection every 3 weeks. The study has three parts: first, doses are increased to find the highest safe dose; second, two doses are compared to pick the best one; third, the chosen dose is given to more people. Blood tests and other checks will be done to monitor safety and effectiveness.
- Time commitment
- The study lasts until the cancer gets worse or side effects stop the treatment, with visits every 3 weeks for the IV infusion and related tests.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Key (for all phases)
- Male or non-pregnant, non-breastfeeding female, age 18 years or older at the date of consent.
- Disease not amenable to curative intent treatment.
- Individuals have exhausted the standard of care treatment (SoC) with expected survival benefit and are not denied SoC with expected survival benefit...
- Individuals with previous systemic topoisomerase I inhibitor treatment (e.g., Topotecan) are allowed in the study.
You likely can't join if
- (for all phases)
- The individual 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.
- Individuals are not allowed to participate in treatment clinical studies either concurrently or within the previous 28 days or within 5 half-lives of...
- Individuals with spinal cord compression or active central nervous system disease, and/or carcinomatous meningitis.
- Prior radiotherapy \<2 weeks from trial inclusion.
See the full eligibility criteria
Who can join
- Key (for all phases)
- Male or non-pregnant, non-breastfeeding female, age 18 years or older at the date of consent.
- Disease not amenable to curative intent treatment.
- Individuals 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.
- Individuals with previous systemic topoisomerase I inhibitor treatment (e.g., Topotecan) are allowed in the study.
- Radiologically measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by the INV.
- 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.
- Individuals must be willing to sign an archival tissue release form for research purposes and determination of biomarker expression.
- Individuals must be willing to undergo a non-contrast high resolution computed tomography (HRCT) of the thorax scan and pulmonary function testing (PFT) at screening.
- Adequate organ function
- Resolution of all acute toxic effects of prior therapy or surgical procedures to ≤grade 1 (except alopecia, hyperpigmentation, or discoloration (incl.
- Individuals 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...
- In the opinion of the investigator, the individual must be able to understand, give written informed consent, and comply with all study-related procedures, medication use, and evaluations.
- The individual must not have a history of non-compliance with medical regimens or be considered potentially unreliable and/or uncooperative.
- The individual must be willing to sign and date the informed consent form (ICF) Key
What rules you out
- (for all phases)
- The individual 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.
- Individuals are not allowed to participate in treatment clinical studies either concurrently or within the previous 28 days or within 5 half-lives of any investigational pharmacologic agents or imaging materials...
- Individuals with spinal cord compression or active central nervous system disease, and/or carcinomatous meningitis.
- Prior radiotherapy \<2 weeks from trial inclusion.
- Major surgery within 21 days prior to signing the ICF, unless the individual is recovered at that time.
- Has a history of non-infectious interstitial lung disease/pneumonitis (ILD)/pneumonitis/radiation pneumonitis that required steroids or has current ILD/pneumonitis.
- Has an oxygen saturation of \<93% on room air at rest.
- Has a QTcF \>470 ms
- History of nephrotic syndrome
- Active corneal disease, or history of corneal disease within 12 months prior to enrollment.
- Active, uncontrolled or severe impairment of the urogenital, renal, hepatobiliary, cardiovascular, gastrointestinal, neurologic, or hematopoietic systems which, in the opinion of the investigator, would predispose the...
- History of another malignancy with ongoing treatment or not yet free from disease for 2 years, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or other malignancy with a...
- Documented other concurrent non-malignant comorbidities such as unstable or uncontrolled pectoral angina, myocardial infarction during the last 6 months, valvular heart disease that requires treatment, acute...
- Any anti-tumor chemotherapy, systemic anti-cancer therapy, radiotherapy (except for local radiation therapy of lesions that may cause imminent complications), hormonal therapy, immunotherapy, or corticoid therapy.
- Concurrent use of strong inhibitors or strong inducers of CYP3A4
- Live vaccines within 30 days prior to study entry.
- Individuals who are HBsAg positive are eligible if they have received Hepatitis B virus (HBV) anti-viral therapy for at least 4 weeks and have an undetectable HBV viral load prior to randomization.
- Individuals with a history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening.
- HIV infected individuals must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease
- Any other known unresolved and active bacterial, viral, fungal, mycobacterial, or other infection at screening.
- History of severe and recurrent infections per INV judgment.
- History of progressive multifocal leukoencephalopathy Note: Other protocol defined Inclusion/Exclusion criteria may apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- Atlanta, Georgia, United States
- Boston, Massachusetts, United States
- East Brunswick, New Jersey, United States
- New York, New York, United States
- Cincinnati, Ohio, United States
- Columbus, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Medford, Oregon, United States
- Fort Worth, Texas, United States
- Irving, Texas, United States
- West Valley City, Utah, United States
- Fairfax, Virginia, United States
- Leuven, Belgium
- Berlin, Germany
- Cologne, Germany
- Cluj-Napoca, Romania
- Madrid, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; Atlanta, Georgia, United States; Boston, Massachusetts, United States; East Brunswick, New Jersey, United States; New York, New York, United States; Cincinnati, Ohio, United States and 12 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.