Gynecologic 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.
STUDY17022
First in Human, Phase 1/1b, Open label, Multicenter Study of Bifunctional EGFR/TGF ß Fusion Protein BCA101 Monotherapy and in Combination Therapy in Patients with EGFR Driven Advanced Solid Tumors
The investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.
Study InformationSTUDY21108
A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec followed by Platinum-doublet Chemotherapy and Bevacizumab Compared with Platinum-doublet Chemotherapy and Bevacizumab in Women with Platinum-Resistant/Refractory Ovarian Cancer (OnPrime/GOG-3076 Study)
The primary objective is to determine Progression-free Survival (PFS) by RECIST 1.1. To determine Objective Response Rate (ORR) and Duration of Response (DOR) by RECIST 1.1, PFS by RECIST 1.1 (in modified population), PFS by iRECIST, Overall Survival (OS), and safety.
Study InformationSTUDY21844
A PHASE II/III STUDY OF PACLITAXEL/CARBOPLATIN ALONE OR COMBINED WITH EITHER TRASTUZUMAB AND HYALURONIDASE-OYSK (HERCEPTIN HYLECTA) OR PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF (PHESGO) IN HER2 POSITIVE, STAGE I-IV ENDOMETRIAL SEROUS CARCINOMA OR CARCINOSARCOMA
This phase II/III trial tests whether adding trastuzumab and hyaluronidase-oysk (Herceptin HylectaTM) or pertuzumab, trastuzumab and hyaluronidase-zzxf (PhesgoTM) to the usual chemotherapy (paclitaxel and carboplatin) works to shrink tumors in patients with HER2 positive endometrial serous carcinoma or carcinosarcoma.
Study InformationSTUDY23164
3068/217908 A Phase III Randomized Trial of Heated Intraperitoneal Chemotherapy (HIPEC) with Cisplatin versus no HIPEC at the Time of Optimal Interval Cytoreductive Surgery followed by Niraparib Maintenance in Patients with Newly Diagnosed Stage III and IV Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
To determine if a single treatment with intraoperative HIPEC with cisplatin at the time of iCRS will result in improved PFS as compared to iCRS alone in patients with stage III or IV EOC who are treated with neoadjuvant IV platinum-based chemotherapy followed by niraparib maintenance.
Study InformationSTUDY23197
Autophagy Maintenance (AUTOMAIN) Therapy in High-Grade Serous Ovarian Cancer: A Phase II Randomized Trial
To assess the safety of HCQ + NFV in combination with standard- of-care maintenance bevacizumab in patients with high-grade serous ovarian cancer. Evaluate the anti-tumor activity of HCQ + NFV in combination with standard-of-care maintenance bevacizumab in patients with high- grade serous ovarian cancer. To assess changes in CA125 in patients treated with HCQ + NFV in combination with standard-of-care maintenance bevacizumab. To assess changes in Quality of Life (QOL) in patients treated with HCQ + NFV in combination with standard-of-care maintenance bevacizumab.
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 InformationSTUDY24416
A Phase 2/3, Multicenter, Randomized Study of Raludotatug Deruxtecan (R-DXd), a CDH6-directed Antibody-drug Conjugate, in Subjects with Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
To evaluate BICR- assessed ORR at each dose level of R-DXd. To evaluate investigator assessed ORR at each dose level of R-DXd. To evaluate the DoR at each dose level of R-DXd.
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 Information