Genitourinary Cancer Trials
Every treatment that has ever made a difference in cancer care was once a part of a clinical trial. MUSC Hollings Cancer Center is committed to offering the best treatments available today while searching for even better ones for the future. Ask your doctor if a clinical trial is right for you.
STUDY22810
A Randomized Open-Label Phase 2/3 Study of BT8009 as Monotherapy or in Combination in Participants with Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2)
To evaluate the efficacy of BT8009 in combination with pembrolizumab, measured by progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1) assessed by blinded independent central review (BICR). To assess clinical activity by the objective response rate (ORR) per RECIST v1.1 assessed by BICR and by the Investigator.
Study InformationSTUDY23849
A Phase 1/2a, Multicenter, Open-Label, First in Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of DB-1311 in Subjects with Advanced/Metastatic Solid Tumors
This is a multicenter, open-label, multiple-dose, FIH Phase 1/2a study. Phase 1 adopts an accelerated titration at first dose level followed with classic "3+3" design to identify the MTD and/or RP2D. Phase 2a is a dose expansion phase to confirm the safety, tolerability and explore efficacy in selected malignant solid tumors treated with DB-1311 as monotherapy.
Study InformationSTUDY23966
A First-in-Human, Phase 1/2, Open-Label, Multi-Center, Dose Escalation, Dose-Optimization, and Dose-Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-Tumor Activity of PARP1 Selective Inhibitor, IMP1734, in Patients with Advanced Solid Tumors
To evaluate the safety and tolerability of IMP1734. To determine the MTD (or MAD) and RDE. To characterize the plasma PK profile of single and multiple doses of IMP1734. To assess preliminary anti-tumor activity of IMP1734.
Study InformationSTUDY23968
A Multicenter, Open-Label Phase 1/1B Dose-Finding, Safety, and Pharmacokinetic Study of MBRC-101, an Anti-EPHA5 Monomethyl Auristatin E (MMAE) Antibody Drug Conjugate, in Advanced Refractory Solid Tumors
To identify potential OBRD and dosing regimens of MBRC-101. To establish the MTD of MBRC-101 using 1 or more dosing regimens. To identify potential RP2Ds and regimens of MBRC-101. To evaluate the safety of MBRC-101 at potential OBRDs, RP2Ds, and dosing regimens. To evaluate preliminary clinical activity of MBRC-101.
Study InformationSTUDY24613
MODERN: An Integrated Phase 2/3 and Phase 3 Trial of MRD-Based Optimization of Adjuvant Therapy in Urothelial Cancer
To compare the ctDNA clearance proportion at 12 weeks in patient enrolled in Cohort A treated with adjuvant nivolumab versus nivolumab + relatimab (phase 2 portion). To compare overall survival in patients enrolled in Cohort A treated with adjuvant nivolumab + relatlimab
Study InformationSTUDY25269
A Phase I, First-in-human, Open-label, Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of BNT317 in Patients With Advanced Solid Tumors
To determine the safety profile, and tolerability of BNT317 in patients with advanced solid tumors. To determine the MTD or the RP2D of BNT317 in patients with advanced solid tumors.
Study InformationSTUDY25563
A Phase 1, Open-Label, Multicenter Study of Janx007 in Subjects with Metastatic Castration-Resistant Prostate Cancer
To assess safety and tolerability in subjects with mCRPC to determine the MTD-R or MAD and to assess potential Phase 2 dose regimens and determine a RP2D-R. To assess the safety and tolerability of JANX007 when administered with recombinant human albumin (rHA). To compare the safety and tolerability of 2 potential RP2D-Rs identified from Part 1 and Part 2. To assess the safety and tolerability in taxane naïve subjects with mCRPC.
Study InformationSTUDY25698
A Phase 3, Two-part, Randomized, Open-label, Adaptive Study Comparing BMS-986365 versus Investigator's Choice of Therapy Comprising Either Docetaxel or Second Androgen Receptor Pathway Inhibitor (ARPI), in Participants with Metastatic Castration-resistant Prostate Cancer (mCRPC) - rechARge
To compare the efficacy of BMS-986365 vs investigator s choice of therapy. To compare the efficacy of BMS-986365 vs investigator s choice of therapy. Part 1 only: to inform the dose of BMS-986365 to continue in part 2 of the study. To further assess the efficacy of BMS-986365 vs investigator s choice of therapy. To investigate the effect on PROs in this study population when treated with BMS-986365 vs investigator's choice of therapy.
Study InformationSTUDY25992
A Phase 3, Single-arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-104, a Novel Formulation of UGN-101, for the Treatment of Patients With Low-grade Upper Tract Urothelial Cancer (LG-UTUC)
To evaluate the tumor ablative effect of UGN-104, a novel formulation of UGN-101, in patients with LG-UTUC. To evaluate the durability of response with respect to DOR and DCR rate at scheduled disease assessment time points.
Study InformationSTUDY26175
A Randomized Phase III Clinical Trial For The Addition Of Docetaxel To Androgen Receptor Pathway Inhibitors In Patients With Metastatic Castration Sensitive Prostate Cancer And Suboptimal PSA Response (TRIPLE-SWITCH)
To compare overall survival in participants with mCSPC who are receiving standard of care ADT (between 6-12 months exposure) + ARPI and have suboptimal PSA response with those who recieve standard of care ADT + ARPI plus docetaxel chemotherapy.
Study Information