A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer
NCT07213804 · Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms
RecruitingThis is a clinical study that has three parts. It is testing a potential new medicine called Sofetabart Mipitecan (Sofe-M) for people with certain types of ovarian, peritoneal, and fallopian tube cancers. Part A enrolls participants with platinum-resistant cancer, meaning their disease progressed during or within six months of platinum-based chemotherapy. Parts B and C enroll participants with platinum-sensitive cancer, whose disease responded and remained controlled for at least six months after completing platinum treatment. The researchers want to find out if Sofe-M works better than the standard treatments that doctors use now and to better understand how safe it is. Each participant's time in the study will depend on how they respond to the treatment.
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 266 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
NCT06760819 · Advanced Solid Tumors, HER2 Mutation
RecruitingResearchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works. In this trial, the researchers want to learn how well BAY2927088 (sevabertinib) works in people with different types of solid tumors with HER2 mutations. These include tumors in the colon or rectum, the uterus and the cervix (lower part of the uterus), the breast, the bladder, and the biliary tract (includes gall bladder and bile ducts) as well as other types of solid tumors with the exception of people with advanced non-small cell lung cancer (NSCLC). Solid tumors may have specific changes or mutations to a gene called human epidermal growth receptor-2 (HER2). This leads to the formation of an abnormal form of HER2 protein in the cancer cells, resulting in increased cell growth. The study treatment, BAY2927088, is expected to block the abnormal HER2 protein which may stop the spread of cancer. The trial will include about 111 participants who are at least 18 years old. All the participants will take 20 mg of BAY2927088 as tablets by mouth. The participants will take treatments in 3-week periods called cycles. These 3-week cycles will be repeated throughout the trial. The participants can take BAY2927088 until their cancer gets worse, until they have medical problems, or until they leave the trial. During the trial, the doctors will take imaging scans of different parts of the body to study the spread of cancer and will check heart health using echocardiogram or cardiac magnetic resonance imaging (MRI) and electrocardiogram (ECG). The doctors will also take blood and urine samples and do physical examinations to check the participants' health. They will ask questions about how the participants are feeling and if they have any medical problems.
PhasePhase 2
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 53 more
SponsorBayer
▾Tap for detailsClick for full details — eligibility, all locations, contacts Uterine Lavage to Detect Ovarian Cancer Risk
NCT07772869 · BRCA Hereditary Ovarian Carcinoma, Fallopian Tube High Grade Serous Adenocarcinoma, Ovarian High Grade Serous Adenocarcinoma
RecruitingThis clinical trial develops a non-surgical approach using uterine lavage samples to screen for progression to ovarian cancer in high-risk patients carrying BRCA mutations. Women with inherited mutations in the BRCA1 and BRCA2 genes (BRCA carriers) have a much higher lifetime risk of developing ovarian cancer. Currently there are no effective ovarian cancer screening or early detection tests for BRCA carriers. Uterine lavage is a procedure that uses saline to rinse and collect cells from the fallopian tube. Molecular analysis of these samples may help proactively detect genetic alterations that are indicative of progression to ovarian cancer in women with BRCA mutations.
PhaseNA
TypeInterventional
Age18 Years
WhereSeattle, Washington, United States
SponsorUniversity of Washington
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies
NCT06395519 · Advanced or Metastatic Solid Tumors,
Breast Cancer,
Ovarian Cancer RecruitingThis is a two-part, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and anti- tumor activity of ETX-19477, a novel reversible small molecule inhibitor of PARG.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 13 more
Sponsor858 Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors
RecruitingThe objective of this study is to evaluate the safety, tolerability, and efficacy of BL-B01D1 in patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WhereBeverly Hills, California, United States + 38 more
SponsorSystImmune Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Triptorelin for the Prevention of Ovarian Damage in Adolescents and Young Adults With Cancer
NCT06513962 · Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
RecruitingThis phase III trial compares the effect of giving triptorelin vs no triptorelin in preventing ovarian damage in adolescents and young adults (AYAs) with cancer receiving chemotherapy with alkylating agents. Alkylating agents are part of standard chemotherapy, but may cause damage to the ovaries. If the ovaries are not working well or completely shut down, then it will be difficult or impossible to get pregnant in the future. Triptorelin works by blocking certain hormones and causing the ovaries to slow down or pause normal activity. The triptorelin used in this study stays active in the body for 24 weeks or about 6 months after a dose is given. After triptorelin is cleared from the body, the ovaries resume normal activities. Adding triptorelin before the start of chemotherapy treatment may reduce the chances of damage to the ovaries.
PhasePhase 3
TypeInterventional
Age39 Years
WhereBirmingham, Alabama, United States + 205 more
SponsorChildren's Oncology Group
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
NCT04251052 · Ovarian Carcinoma
RecruitingThis clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations.
PhaseNA
TypeInterventional
Age35 Years – 50 Years
WhereBirmingham, Alabama, United States + 573 more
SponsorNRG Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of NX-1607 in Adults With Advanced Malignancies
NCT05107674 ·
Ovarian Cancer, Epithelial, Gastric Cancer, GastroEsophageal Junction (GEJ) Cancer
RecruitingThis is a first-in-human Phase 1a/1b multicenter, open-label oncology study designed to evaluate the safety and anti-cancer activity of NX-1607 in patients with advanced malignancies.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 16 more
SponsorNurix Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25
NCT05879926 ·
Breast Cancer RecruitingThis Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).
PhasePhase 3
TypeInterventional
Age18 Years – 60 Years
WhereBirmingham, Alabama, United States + 1260 more
SponsorNRG Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
NCT06778863 · Advanced Solid Tumor, Unresectable Solid Tumor, Metastatic Solid Tumor
RecruitingPhase 1 dose escalation and expansion study of CLSP-1025, a first-in-class HLA-A\*02:01 specific T cell engager (TCE) targeting solid tumors that harbor the p53 R175H mutation.
PhasePhase 1
TypeInterventional
Age18 Years
WhereScottsdale, Arizona, United States + 20 more
SponsorClasp Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Risk Reducing Salpingectomy With Delayed Oophorectomy as an Alternative to Risk- Reducing Salpingo-oophorectomy in High Risk-Women to Assess the Safety of Prevention - US Cohort Study
NCT05287451 ·
Ovarian Cancer, Fallopian Tube Cancer
RecruitingThis is a prospective preference study that will evaluate non-inferiority of the innovative treatment (RRS with delayed RRO) as compared to the standard treatment (RRSO) with respect to high grade serous (ovarian) cancer incidence
PhaseNA
TypeInterventional
Age18 Years
WhereBoston, Massachusetts, United States + 8 more
SponsorM.D. Anderson Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors
RecruitingA Study of Emi-Le in Participants with Solid Tumors
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 25 more
SponsorDay One Biopharmaceuticals, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention
NCT04294927 · BRCA1 Gene Mutation, BRCA2 Gene Mutation, RAD51C Gene Mutation
RecruitingThe aim of the project is to evaluate the risk-reducing salpingectomy with delayed oophorectomy as an alternative for risk-reducing salpingo-oophorectomy in high risk women with respect to ovarian cancer incidence.
PhaseNA
TypeInterventional
Age25 Years – 50 Years
WhereChicago, Illinois, United States + 65 more
SponsorUniversity Medical Center Nijmegen
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
NCT06172478 · Advanced Solid Tumor,
Melanoma, Head and Neck Cancer
RecruitingThis is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced unresectable or metastatic solid tumors. The study is enrolling cohorts of participants with melanoma \[cutaneous/acral\], squamous cell carcinomas of the head and neck (SCCHN), HER2-negative gastric cancer ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, second-line gastric cancer, lung cancer, and breast cancer.
PhasePhase 2
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 89 more
SponsorDaiichi Sankyo
▾Tap for detailsClick for full details — eligibility, all locations, contacts Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
RecruitingObjective: To collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment. Design: This is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.
Phase—
TypeObservational
Age18 Years
WhereGilbert, Arizona, United States + 15 more
SponsorA2 Biotherapeutics Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study to Evaluate INCB123667 Versus Investigator's Choice of Chemotherapy in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
NCT07214779 ·
Ovarian Cancer RecruitingThe purpose of this study is to evaluate INCB123667 versus investigator's choice of chemotherapy in participants with platinum-resistant ovarian cancer with cyclin E1 overexpression.
PhasePhase 3
TypeInterventional
Age18 Years
WhereAnchorage, Alaska, United States + 191 more
SponsorIncyte Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression
NCT06051695 · Solid Tumor, Adult,
Colorectal Cancer, NSCLC
RecruitingThe goal of this study is to test autologous logic-gated Tmod™ CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\*02 expression. The main questions this study aims to answer are: Phase 1: What is the recommended dose that is safe for patients Phase 2: Does the recommended dose kill solid tumor cells and protect the patient's healthy cells Participants will be required to perform study procedures and assessments, and will also receive the following study treatments: Enrollment and Apheresis in BASECAMP-1 (NCT04981119) Preconditioning Lymphodepletion (PCLD) Regimen Tmod CAR T cells at the assigned dose
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereGilbert, Arizona, United States + 11 more
SponsorA2 Biotherapeutics Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts SMP-3124LP in Adults With Advanced Solid Tumors
NCT06526819 · Solid Tumor
RecruitingAn Open-label, Phase I Dose Escalation and Phase 2 Dose Expansion Study to Assess Safety, Tolerability, Preliminary Antitumor Activity of SMP 3124LP in Adults with Advanced Solid Tumors
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 11 more
SponsorSumitomo Pharma America, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Find Out How Safe REGN5668 is and How Well it Works In Adult Women When Given With Either Cemiplimab, or Cemiplimab + Fianlimab, or Ubamatamab
NCT04590326 ·
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
RecruitingThis study is researching an investigational drug called REGN5668 : * alone or, * combined with cemiplimab (also known as REGN2810) or, * combined with both cemiplimab and fianlimab (also known as REGN3767), or * combined with ubamatamab (also known as REGN4018), with or without sarilumab. The main purposes of this study are to: * Learn about the safety and profile of any side effects from the study drugs and to determine the highest, safe dose that can be given to participants with ovarian cancer or cancer of the uterus * Look for signs that the study drugs can treat ovarian cancer or cancer of the uterus This study has 2 parts. The purpose of Part 1 (Escalation) is to find the highest, safe dose of the study drug(s). The purpose of Part 2 (Expansion) is to use the doses chosen in Part 1. Participants with cancer of the uterus will only participate in Part 2. The study is looking at several other research questions, including: * Side effects that may be experienced by participants taking REGN5668 alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab * How REGN5668 works in the body either alone and/or in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab * How much of the study drugs (REGN5668, cemiplimab, fianlimab, ubamatamab) are in the blood * To see if REGN5668 in combination with cemiplimab, cemiplimab and fianlimab, or ubamatamab works to treat cancer
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 27 more
SponsorRegeneron Pharmaceuticals
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Raludotatug Deruxtecan (R-DXd) in Subjects With Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
NCT06161025 · Solid Cancer
RecruitingThis study will evaluate the safety and efficacy of R-DXd therapy in participants with ovarian, peritoneal, or fallopian tube cancer.
PhasePhase 2 / Phase 3
TypeInterventional
Age18 Years
WhereAnchorage, Alaska, United States + 163 more
SponsorDaiichi Sankyo
▾Tap for detailsClick for full details — eligibility, all locations, contacts