Table of contents
- Trial overview
- Who can join the studies
- What the trials measure
- Trial phases and study design
- Study sizes and status
- Why these trials matter
Trial overview
Two authorised clinical trials are investigating Tub-040 in people with certain hard-to-treat cancers.[1][2] One study is testing Tub-040 in platinum-resistant high-grade ovarian cancer and relapsed/refractory adenocarcinoma non-small cell lung cancer.[1] The other study is testing Tub-040 in women with high-grade epithelial serous or endometrioid epithelial ovarian cancer.[2]
Who can join the studies
The first study includes adults with ovarian cancer that is resistant to platinum treatment, or people with non-small cell lung cancer that has come back or has not responded to treatment.[1] The second study includes women with high-grade epithelial serous or endometrioid epithelial ovarian cancer.[2] These are patient groups with cancers that often need new treatment options.[1][2]
What the trials measure
The main safety measure in both trials is treatment-emergent adverse events (TEAEs), which means side effects that start or get worse after treatment begins.[1][2] The studies also measure dose-limiting toxicities (DLTs), which are serious side effects that may stop doctors from increasing the dose.[1][2] In the Phase 1/2 study, researchers also look at overall response rate (ORR), which shows how many patients have a tumor response based on central review.[1]
Trial phases and study design
The first trial is a Phase 1/2 interventional study, so it starts by checking safety and dose, then moves to early testing of activity.[1] Its Phase I part uses dose escalation, which means the dose is increased step by step to find the safest useful dose.[1] The study aims to find the maximum tolerated dose (MTD) or the identified dose for optimization, and later the recommended Phase 2 dose for future development.[1]
The second trial is a Phase 1 interventional study of Tub-040 given with standard chemotherapy.[2] Its goal is to check safety and tolerability and to find the MTD, if one is observed.[2] This means the study is mainly focused on finding a dose that can be studied further in future research.[2]
Study sizes and status
The Phase 1/2 study plans to enroll 250 participants and is listed as authorised.[1] The Phase 1 study plans to enroll 72 women and is also listed as authorised.[2] Both studies are still in the early research stage, where the main question is whether the treatment can be given safely and how the dose should be set.[1][2]
Why these trials matter
These trials are important because they focus on cancers that can be difficult to treat after standard therapy has stopped working.[1][2] For patients, the key questions are whether Tub-040 can be given safely, what side effects may appear, and whether it shows early signs of helping the cancer.[1][2] The results will help researchers decide whether Tub-040 should move into later studies.[1]
