A Phase 1/2 Trial of TER-2013 in Patients With Solid Tumors Harboring AKT/PI3K/PTEN Pathway Alterations
NCT07109726 ·
Breast Cancer, Endometrial Cancer,
Ovarian Cancer RecruitingThis is a Phase 1/2, open-label, multicenter study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of TER-2013 in patients with advanced solid tumors harboring AKT/PI3K/PTEN pathway alterations.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 17 more
SponsorTerremoto Biosciences Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts 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 Testing Different Amounts of the Combination of Drugs M1774 and ZEN-3694 for the Treatment of Recurrent Ovarian and Endometrial Cancer
NCT05950464 · Recurrent Endometrial Carcinoma, Recurrent Endometrial Clear Cell Adenocarcinoma, Recurrent Endometrial Endometrioid Adenocarcinoma
RecruitingThis phase Ib trial tests the safety, side effects, and best dose of M1774 when given with ZEN-3694 in treating patients with ovarian and endometrial cancer that has come back (recurrent). M1774 and ZEN-3694 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. M1774 and ZEN-3694 combined together has demonstrated to be better than either drug alone in killing ovarian tumor cells.
PhasePhase 1
TypeInterventional
Age18 Years
WhereAugusta, Georgia, United States + 13 more
SponsorNational Cancer Institute (NCI)
▾Tap for detailsClick for full details — eligibility, all locations, contacts CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.
NCT06690775 ·
Epithelial Ovarian Cancer, Primary Peritoneal, Fallopian Tube Cancer
RecruitingA Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer.
PhasePhase 2
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 65 more
SponsorTORL Biotherapeutics, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
NCT05051722 · Endometrial Cancer, Cervical Cancer, Atypical Endometrial Hyperplasia
RecruitingThe overarching objective of this project is to develop a pan-gynecologic cancer detection test using gynecologic (unique endometrial, cervical, and ovarian cancer) cancer-specific methylated DNA markers and high-risk human papilloma virus (HR-HPV) detected in vaginal fluid and/or plasma. This proposal defines Phase II MDM-based cancer detection studies in endometrial cancer (EC) and endometrial hyperplasia with atypia (AEH) in vaginal fluid and 2) ovarian cancer (OC) in plasma and vaginal fluid. Additionally, it defines necessary Phase I MDM-based cancer detection and exploratory aims to test novel cervical cancer (CC) MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.er detection and exploratory aims to test novel cervical cancer MDMs and test the specificity of cancer-specific MDMs among various common benign gynecologic pathologies.
Phase—
TypeObservational
Age18 Years
WherePhoenix, Arizona, United States + 23 more
SponsorMayo Clinic
▾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 An Evaluation of Maintenance Therapy Combination Mirvetuximab Soravtansine and Olaparib
NCT05887609 · Ovary Cancer, Peritoneal Cancer, Fallopian Tube Cancer
RecruitingThe Principal Investigator hypothesizes the combination of MIRV and Olaparib is an effective, and tolerable, maintenance therapy strategy in platinum sensitive recurrent ovarian cancer.
PhasePhase 2
TypeInterventional
Age18 Years – 100 Years
WhereIrvine, California, United States + 5 more
SponsorUniversity of Colorado, Denver
▾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 A Clinical Trial to Evaluate the Safety and Efficacy of COM701 in Relapsed Platinum Sensitive Ovarian Cancer
RecruitingThe goal of this clinical trial is to learn if the experimental antibody COM701 delays the progression of ovarian cancer in participants with Relapsed Platinum Sensitive Ovarian Cancer. It will also learn about the safety of COM701. The main questions the trial aims to answer are: * Does COM701, when used as a maintenance treatment, stop or slow the progression of ovarian cancer? * Does COM701 delay the time to needing a new anti-cancer treatment? * What side effects do participants have when taking COM701? Participants will: * Visit the clinic once every 3 weeks during which the study treatment will be administered intravenously * Undergo various tests and procedures to monitor general health throughout the trial including physical examinations, vital sign measurements (heart rate, blood pressure, breathing, and body temperature), weight measurements, electrocardiography (ECG), blood and urine tests and pregnancy tests if relevant. * Undergo various tests and procedures to assess disease response throughout the trial including tumor imaging by CT scans or MRI to assess the tumor, its location, and size, and the testing of a sample of tumor tissue (from a prior biopsy or a fresh biopsy if feasible, to evaluate tumor response to treatment and to measure levels of tumor markers,
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereAugusta, Georgia, United States + 27 more
SponsorCompugen Ltd
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400
NCT06084481 · Hepatocellular Carcinoma, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancers
RecruitingCancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors. ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called cohorts. Cohorts 1-8 receive ABBV-400 alone (monotherapy), cohort 9 receives ABBV-400 with a strong CYP3A3 inhibitor (ITZ), and cohort 10 receives ABBV-400 with bevacizumab. All cohorts are followed by a safety follow-up period. Approximately 325 adult participants with hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), esophageal squamous cell carcinoma (ESCC), triple negative breast cancer (TNBC), hormone receptor+/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (hormone receptor-positive \[HR+\]/HER2-breast cancer \[BC\]), head and neck squamous-cell-carcinoma (HNSCC), Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer, or advanced solid tumors, will be enrolled in the study in approximately 54 sites worldwide. In cohorts 1-8, participants with the following advanced solid tumor indications: HCC, PDAC, BTC, ESCC, TNBC, HR+/HER2-BC, HNSCC, and PROC/primary peritoneal/fallopian tube cancer will receive intravenous (IV) ABBV-400 monotherapy, in cohort 9 participants will receive IV ABBV-400 and an oral solution of ITZ, and in cohort 10 participants will receive IV ABBV-400 and IV bevacizumab, for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 53 more
SponsorAbbVie
▾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 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 Physical Activity Intervention Among Older Women With Gynecologic Cancers (Fit4Treatment)
NCT05743517 · Ovary Cancer, Endometrial Cancer, Uterine Cancer
RecruitingThe primary purpose of the study is to determine which of four components (symptom-burden tailored app, exercise partner, oncology provider engagement, coaching) added to a core intervention of a wearable activity tracker and commercially available app, will improve physical activity. The findings will generate meaningful knowledge about how to best increase physical activity in older gynecologic cancer patients receiving systemic cancer therapies to improve quality of life and cancer-specific survival.
PhaseNA
TypeInterventional
Age60 Years
WhereChicago, Illinois, United States
SponsorNorthwestern University
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of PHST001 in Advanced Solid Tumors
NCT06840886 · Advanced Solid Tumors,
Ovarian Cancer, Endometrial Cancer
RecruitingThis is a multi-center, first-in-human (FIH), open-label, Phase 1a/1b dose escalation and dose expansion study to assess the safety, PK, pharmacodynamics, and antitumor activity of PHST001 monotherapy (Phase 1a) or in combination with chemotherapy (Phase 1b) in adult participants with advanced relapsed and/or refractory solid tumors (including but not limited to CNS tumors in Phase 1a only). In Phase 1b cohort expansions, the study will focus on participants with advanced relapsed and/or refractory ovarian cancer, endometrial cancer, and cholangiocarcinoma. The study's primary objective is to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001 monotherapy and in combination with chemotherapy as well as assess the anti-tumor activity of PHST001 and chemotherapy in Phase 1b.
PhasePhase 1
TypeInterventional
Age18 Years
WhereBeverly Hills, California, United States + 19 more
SponsorPheast Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts