A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
NCT06270706 · Advanced or Metastatic Solid Tumor
RecruitingThis is a Phase 1a/1b, dose-escalation/expansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, PK, PD, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab (the study treatment regimen) in adult participants with advanced or metastatic solid tumors for which pembrolizumab is indicated but have documented disease progression (refractory \[primary resistance\]) or relapsed \[secondary resistance\]) after at least 3 months from the start of treatment with pembrolizumab. The study will consist of 2 main parts: * Part 1: Consecutive dose-escalation cohorts using a Bayesian optimal interval (BOIN) dose escalation design with accelerated titration * Part 2: Dose-expansion cohorts using Simon's 2-stage design
PhasePhase 1
TypeInterventional
Age18 Years
WhereNew Haven, Connecticut, United States + 11 more
SponsorPliant Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Azenosertib (ZN-c3) in Subjects With Platinum-Resistant High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer
NCT05128825 · High-Grade Serous Ovarian, Fallopian Tube or Primary Peritoneal Cancer
RecruitingThis is a multi-part Phase 2 study to evaluate the efficacy and safety of azenosertib (ZN-c3) in subjects with Platinum-Resistant, High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer. Part 2 of the study will be conducted in subjects whose tumors are Cyclin E1 positive as determined by central review using the Sponsor's investigational clinical trial assay.
PhasePhase 2
TypeInterventional
Age18 Years
WhereMobile, Alabama, United States + 91 more
SponsorK-Group, Beta, Inc., a wholly owned subsidiary of Zentalis Pharmaceuticals, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors
NCT05768139 ·
Breast Cancer, Solid Tumors, Adult
RecruitingStudy STX-478-101 (LY4064809) is a multipart, open-label, phase 1/2 study evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of STX-478 (LY4064809) in participants with advanced solid tumors with P13Ka mutations. Part 1 will evaluate STX-478 as monotherapy in participants with advanced solid tumors. Part 2 will evaluate STX-478 therapy as combination therapy with fulvestrant in participants with hormone receptor positive (HR+) breast cancer. Part 3 will evaluate STX-478 as combination therapy with endocrine therapy (aromatase inhibitors, fulvestrant, tamoxifen, or imlunestrant) and a CDK4/6 Inhibitor (either Ribociclib, Palbociclib or Abemaciclib) in participants with HR+ breast cancer. Each study part will include a 28-day screening period, followed by treatment with STX-478 monotherapy or combination therapy.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 64 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase 1/2a Study of DB-1311/BNT324 in Advanced/Metastatic Solid Tumors
NCT05914116 · Advanced Solid Tumors
RecruitingThis is a dose-escalation and dose-expansion Phase 1/2a trial to evaluate the safety and tolerability of DB-1311/BNT324 in subjects with advanced solid tumors.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereTucson, Arizona, United States + 106 more
SponsorDualityBio Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of ASP546C in Adults With Gastroesophageal Cancer, Pancreatic Cancer or Other Solid Tumors
NCT07488676 · Gastric or Gastro-esophageal Junction (GEJ) Adenocarcinoma, Pancreatic Adenocarcinoma
RecruitingThis study will help find the most suitable dose of ASP546C in people with gastric cancer, gastroesophageal junction (GEJ) cancer, pancreatic cancer, and other specific solid tumors. GEJ is where the food pipe (esophagus) joins the stomach. This study is in 2 parts. In both parts of the study, ASP546C will be given once in 3-week cycles. It will be given slowly through a tube into a vein. This is called an infusion. In Part 1, people with gastric cancer or GEJ cancer can take part. They will receive an infusion of either a higher dose or a lower dose of ASP546C. In Part 2, people with pancreatic cancer or who have one of the other solid tumors can take part. Part 2 doesn't include people with gastric cancer or GEJ cancer. All people in this part of the study will receive an infusion of the higher dose of ASP546C. People will visit the clinic on certain days to receive ASP546C and have health checks. The number of visits and checks done during the study will depend on the health of each person and whether they are still receiving infusions of ASP546C.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 16 more
SponsorAstellas Pharma Global Development, Inc.
▾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 Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
NCT06276491 ·
Ovarian Cancer, Endometrial Cancer, Germ Cell Tumor
RecruitingThe primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate the effect of XmAb541 on tumor outcomes.
PhasePhase 1
TypeInterventional
Age15 Years
WhereDuarte, California, United States + 21 more
SponsorXencor, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Repurposing Atovaquone for the Treatment of Platinum-Resistant Ovarian Cancer
NCT05998135 · Ovarian High Grade Serous Adenocarcinoma, Platinum-Resistant Ovarian Carcinoma
RecruitingThis phase II trial test tests how well repurposing atovaquone works in treating patients with platinum-resistant ovarian cancer. Atovaquone is used for the treatment or prevention of certain infections. Atovaquone is in a class of medications called antiprotozoal agents. It works by stopping the growth of certain types of protozoa that can cause pneumonia. Giving atovaquone may be effective in treating platinum-resistant ovarian cancer and result in improved outcomes compared to standard chemotherapy regimens.
PhasePhase 2
TypeInterventional
Age18 Years
WhereAtlanta, Georgia, United States
SponsorEmory University
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Sofe-M in Participants With Selected Advanced Solid Tumors
NCT06400472 · Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms
RecruitingThe purpose of this study is to find out whether the study drug, Sofetabart Mipitecan (LY4170156), is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in three parts - phase Ia (dose-escalation, dose-optimization), phase Ib (dose-expansion), and phase 2 (dose expansion). The study will last up to approximately 5 years.
PhasePhase 1
TypeInterventional
Age18 Years
WhereScottsdale, Arizona, United States + 23 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types
NCT04300556 · Solid Tumor
RecruitingThe primary objectives of the study are: (1) in the dose-escalation part: to evaluate safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of farletuzumab ecteribulin (MORAb-202) in participants with selected tumor types (ovarian cancer \[OC\], endometrial cancer \[EC\], non-small cell lung carcinoma \[NSCLC\], triple-negative breast cancer \[TNBC\]), and (2) in dose-confirmation part: to evaluate preliminary efficacy measured by objective response rate (ORR) of farletuzumab ecteribulin (MORAb-202) in participants with OC and EC at selected doses and to further evaluate the safety and tolerability of farletuzumab ecteribulin (MORAb-202) and (3) dose-optimization part. (divided in two parts: Part A \[OC and EC participants\] and Part B \[OC only\]): Part A: to evaluate other farletuzumab ecteribulin (MORAb-202) treatment regimens for safety, tolerability and preliminary efficacy in participants with OC and EC; to evaluate the addition of short course of oral corticosteroids following every dose of farletuzumab ecteribulin (MORAb-202) administered every 21 days; and to select treatment regimens with farletuzumab ecteribulin (MORAb-202) for further evaluation in Part B. Part B: to evaluate the safety and tolerability of different doses of farletuzumab ecteribulin (MORAb-202) as monotherapy and in combination with lenvatinib and to determine the recommended dose (RD) of farletuzumab ecteribulin (MORAb-202) as monotherapy and in combination with lenvatinib.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereTucson, Arizona, United States + 57 more
SponsorEisai Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Clinical Trial of Sac-TMT in People With Non-HRD Positive Advanced Ovarian Cancer (MK-2870-021)
NCT07318558 · Ovarian Neoplasms,
Ovarian Cancer RecruitingResearchers are looking for new ways to treat ovarian cancer (OC). Current treatment for OC may start with surgery to remove as much of the cancer as possible. After surgery, people may receive chemotherapy. After chemotherapy, standard care options may include: * Maintenance treatment, which is used after another therapy to keep the cancer from growing, spreading, or coming back. Bevacizumab is a targeted therapy used as standard maintenance treatment. Targeted therapy works to control how specific types of cancer cells grow and spread. * Observation, which is watching to see if cancer grows or worsens The study medicine, sacituzumab tirumotecan (also called sac-TMT), is a targeted therapy. The goal of this study is to learn if people who receive sac-TMT maintenance treatment with or without bevacizumab live longer without the cancer getting worse than people who receive standard care.
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 161 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
RecruitingThis study collects blood and tissue samples from patients with cancer and without cancer to evaluate tests for early cancer detection. Collecting and storing samples of blood and tissue from patients with and without cancer to study in the laboratory may help researchers develop tests for the early detection of cancers.
Phase—
TypeObservational
Age40 Years – 75 Years
WhereAnchorage, Alaska, United States + 744 more
SponsorAlliance for Clinical Trials in Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors
NCT04851119 · Colorectal Carcinoma, Endometrial Carcinoma,
Melanoma RecruitingThis phase I/II trial evaluates the highest safe dose, side effects, and possible benefits of tegavivint in treating patients with solid tumors that has come back (recurrent) or does not respond to treatment (refractory). Tegavivint interferes with the binding of beta-catenin to TBL1, which may help stop the growth of tumor cells by blocking the signals passed from one molecule to another inside a cell that tell a cell to grow.
PhasePhase 1 / Phase 2
TypeInterventional
Age12 Months – 30 Years
WhereBirmingham, Alabama, United States + 20 more
SponsorChildren's Oncology Group
▾Tap for detailsClick for full details — eligibility, all locations, contacts Clinical Pre-screening Protocol for Ovarian Cancer
NCT03877796 ·
Ovarian Cancer RecruitingThe patient's local archival tumor tissue (FFPE) from original tumor, or from the metastatic tissue, will be collected to potentially identify if they - at a later stage of their disease - will be likely to benefit from treatment with any of the investigational cancer drugs available to Allarity Therapeutics. Data from this study can further be used to explore in a retrospective fashion, sensitivity to other chemotherapeutic drugs previously used in the treatment of their ovarian cancer, to investigate whether or not the DRP® method can predict and confirm the obtained sensitivity to the prior given drugs as well as prospective analyses guiding the Investigators on future treatments.
Phase—
TypeObservational
Age18 Years
WhereTampa, Florida, United States + 8 more
SponsorAllarity Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)
NCT06824467 ·
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
RecruitingThe main goals of this study are to learn about the safety of sacituzumab tirumotecan with bevacizumab and if people tolerate it; and if people who take sacituzumab tirumotecan with or without bevacizumab live longer without the cancer getting worse than those who receive standard of care treatment.
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 195 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0505 in Adult Participants with Advanced Solid Tumors
PhasePhase 1
TypeInterventional
Age18 Years
WhereOrlando, Florida, United States + 16 more
SponsorNextCure, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts SYNERGY-AI: Artificial Intelligence Based Precision Oncology Clinical Trial Matching and Registry
NCT03452774 · Cancer, Metastatic,
Cancer, Cancer of Pancreas
RecruitingInternational registry for cancer patients evaluating the feasibility and clinical utility of an Artificial Intelligence-based precision oncology clinical trial matching tool, powered by a virtual tumor boards (VTB) program, and its clinical impact on pts with advanced cancer to facilitate clinical trial enrollment (CTE), as well as the financial impact, and potential outcomes of the intervention.
Phase—
TypeObservational
AgeAny
WhereBirmingham, Alabama, United States + 67 more
SponsorMassive Bio, 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 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 Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer
RecruitingThis study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.
PhasePhase 3
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 105 more
SponsorVerastem, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts