A Phase 1/2a Pilot Study of Intravesical TSD-001 for Treatment of Low-Grade, Stage Ta, Non Muscle Invasive Bladder Cancer
TesoRx subsidiary, LIPAC Oncology, has commenced enrollment of Part 1 of a Phase 1/2a study in the 1st quarter of 2018 to establish the maximum tolerable dose for TSD-001 in patients with low grade non-muscle invasive bladder cancer. Part 2 will follow thereafter to establish responder rates by administering the maximum tolerated dose established in Part 1 in a marker legion study in similar patients.
Part 1 of the study will enroll 6 subjects (3 per cohort) with low-grade, stage Ta transitional cell carcinoma (TCC) of the bladder who will receive escalating doses of paclitaxel formulated as TSD-001 every 2 weeks for 6 treatments until Dose Limiting Toxicity (or until the Maximum Deliverable Dose) is observed (Maximum Tolerated Dose established).
Part 2 of the study will enroll an additional 10 subjects with low-grade, stage Ta (multifocal) TCC of the bladder who will receive weekly TSD-001 for 6 weeks at the highest nontoxic dose (i.e., MTD) established in part 1 of the study.
Read more about the TSD-001 Trial.