cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
NCT05366881 · Brain Cancer,
Breast Cancer, Bladder Cancer
RecruitingThis is an observational case-control study to train and validate a genome-wide methylome enrichment platform to detect multiple cancer types and to differentiate amongst cancer types. The cancers included in this study are brain, breast, bladder, cervical, colorectal, endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia, lung, lymphoma, multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and thyroid. These cancers were selected based on their prevalence and mortality to maximize impact on clinical care. Additionally, the ability of the whole-genome methylome enrichment platform to detect minimal residual disease after completion of cancer treatment and to detect relapse prior to clinical presentation will be evaluated in lung cancer. This cancer was selected based on the existing clinical landscape and treatment availability.
Phase—
TypeObservational
Age40 Years
WhereDuarte, California, United States + 16 more
SponsorAdela, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors
NCT04429542 · Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of Anal Canal,
Colorectal Cancer RecruitingThe 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.
PhasePhase 1
TypeInterventional
Age18 Years
WhereLa Jolla, California, United States + 19 more
SponsorBicara Therapeutics
▾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 + 265 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
NCT04585750 · Advanced Solid Tumor, Advanced Malignant Neoplasm, Metastatic Cancer
RecruitingThe Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.
PhasePhase 1 / Phase 2
TypeInterventional
Age12 Years
WhereIrvine, California, United States + 76 more
SponsorPMV Pharmaceuticals, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types
NCT07503808 · Esophageal Squamous Cell Carcinoma,
High Grade Serous Ovarian Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingThis is a Phase 1a/1b, open-label, multicenter dose escalation and dose expansion clinical study to evaluate the safety, PK, immunogenicity and preliminary efficacy of IDE034 in participants with locally advanced/metastatic solid tumor types that express B7-H3 and PTK7.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDenver, Colorado, United States + 14 more
SponsorIDEAYA Biosciences
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Assess Change in Disease Activity and Adverse Events in Adult Participants With Gynecologic Cancers Receiving Intravenous Infusion of IMGN151 as Monotherapy or in Combination With Other Therapies
NCT07024784 · Gynecologic Cancers,
Platinum-Sensitive Ovarian Cancer, Fallopian Tube Cancer
RecruitingCancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess safety and tolerability of IMGN151 when given as monotherapy and in combination with other anti-cancer therapies in adult participants with gynecologic cancers. IMGN151 is an investigational drug being developed for the treatment of gynecologic cancers. Participants are placed in 1 of 4 groups, called treatment arms. Each group receives a different treatment. Around 377 participants with gynecologic cancers will be enrolled in the study at approximately 50 sites worldwide. Participants will receive intravenous infusions of IMGN151 as monotherapy or in combination with anti-cancer therapies according to their assigned study arm. In Arm A, participants will receive IMGN151 in combination with carboplatin on Day 1 of each cycle. In Arm B, participants will receive IMGN151 in combination with olaparib, twice a day (BID) on Day 1 of each cycle. In Arm C, participants will receive IMGN151 in combination with bevacizumab on Day 1 of each cycle. In Arm D, participants will receive IMGN151 as monotherapy on Day 1 of each cycle. In Arm E, participants will receive IMGN151 as monotherapy on Day 1 of each cycle. In Arm F, participants will receive IMGN151 as monotherapy on Day 1 of each cycle. The total study duration will be approximately 3 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 a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
PhasePhase 2
TypeInterventional
Age18 Years
WhereTeaneck, New Jersey, United States + 15 more
SponsorAbbVie
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of MGC026 in Participants With Advanced Solid Tumors
NCT06242470 · Advanced Solid Tumor, Advanced Cancer, Metastatic Cancer
RecruitingThe study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study. Participants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.
PhasePhase 1
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 11 more
SponsorMacroGenics
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study With NKT3964 for Adults With Advanced/Metastatic Solid Tumors
NCT06586957 · Solid Tumor, Advanced Solid Tumor, Solid Tumor, Adult
RecruitingThe goal of the Dose Escalation phase of the study is to evaluate the safety, tolerability, pharmacokinetics (PK) and preliminary anti-tumor activity to determine the preliminary recommended dose for expansion (RDE) of NKT3964 in adults with advanced or metastatic solid tumors. The goal of the Expansion phase of the study is to evaluate the preliminary anti-tumor activity of NKT3964 at the RDE based on objective response rate (ORR) and determine the preliminary recommended Phase 2 dose (RP2D).
PhasePhase 1
TypeInterventional
Age18 Years
WhereLittle Rock, Arkansas, United States + 18 more
SponsorNiKang Therapeutics, Inc.
▾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 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 + 182 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Patients will be registered prior to, during or at the completion of neoadjuvant chemotherapy given per standard institutional guidelines +/- bevacizumab on Day 1 every 21 days for 3-4 cycles. Registered patients who progress during neoadjuvant chemotherapy will not be eligible for iCRS and will be removed from the study. Following completion of neoadjuvant chemotherapy, interval cytoreductive surgery (iCRS) will be performed in the usual fashion in both arms. Patients will be randomized at the time of iCRS (iCRS must achieve no gross residual disease or no disease \>1.0 cm in largest diameter) to receive HIPEC or no HIPEC. Patients randomized to HIPEC Arm will receive a single dose of cisplatin (100mg/m2 IP over 90 minutes at 42 C) as HIPEC. After postoperative recovery patients will receive standard post-operative platinum-based combination chemotherapy. Patients randomized to surgery only (No HIPEC Arm) will receive postoperative standard chemotherapy after recovery from surgery. Both groups will receive an additional 2-3 cycles of platinum-based combination chemotherapy per standard institutional guidelines +/- bevacizumab for a maximum total of 6 cycles of chemotherapy (neoadjuvant plus post-operative cycles) followed by niraparib individualized dosing +/- bevacizumab until progression or 36 months (if no evidence of disease).
PhasePhase 3
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 58 more
SponsorGOG Foundation
▾Tap for detailsClick for full details — eligibility, all locations, contacts 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 + 5 more
SponsorPliant Therapeutics, 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 + 13 more
SponsorAstellas Pharma Global Development, Inc.
▾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 This is a Phase 1 Trial of ZM008, an Anti-LLT1 Antibody, Used as Single Agent Followed by Combination Treatment With Toripalimab in Patients With Advanced Solid Tumors
NCT06451497 ·
Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Pancreas Adenocarcinoma
RecruitingThis is a phase 1 dose escalation trial of ZM008, an anti-LLT1 antibody as a single agent followed by combination with Toripalimab in patients with advanced solid tumors who have exhausted all standard therapy available or are intolerant of the same.
PhasePhase 1
TypeInterventional
Age18 Years
WhereBoston, Massachusetts, United States + 2 more
SponsorZumutor Biologics Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of DR-0202 in Patients With Locally Advanced or Metastatic, Relapsed or Refractory Carcinomas
RecruitingA phase 1a/1b, multicenter, open-label, dose escalation/expansion, multiple-dose study to evaluate the safety and activity of DR-0202 in patients with locally advanced or metastatic, relapsed or refractory carcinomas
PhasePhase 1
TypeInterventional
Age18 Years
WhereDenver, Colorado, United States + 9 more
SponsorDren Bio
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult Participants With Ovarian Cancer
NCT07059845 ·
Ovarian Cancer RecruitingOvarian cancer is a lethal disease with an estimated 310,000 new cases and 200,000 deaths experienced worldwide in 2020. The purpose of this study is to assess the adverse events and change in disease activity of mirvetuximab soravtansine with carboplatin, or bevacizumab (Bev), or bev alone in participants with ovarian cancer (OC). Participants must have confirmation of folate receptor alpha (FRa) positivity by the Ventana folate receptor 1 (FOLR1) Assay. Mirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC. Participants will be assigned to 1 of 3 substudies and further into groups called treatment arms. In substudy 1, arms A-C, participants will receive 1 of 2 doses of MIRV with Bev, or Bev alone. In substudy 2, arms D and E, participants will receive 1 of 2 doses of MIRV with carboplatin, followed by MIRV alone. In substudy 3, arms F and G, participants will receive one of two doses of MIRV with BEV and carboplatin, followed by MIRV with BEV. Approximately 400 participants will be enrolled in the study at 100 sites around the world. Participants will receive intravenously (IV) infused MIRV with IV infused carboplatin, or IV infused Bev, or IV infused carboplatin and Bev, or IV infused Bev alone. The total study duration will be approximately 40 months. 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 a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
PhasePhase 2
TypeInterventional
Age18 Years
WhereLa Jolla, California, United States + 77 more
SponsorAbbVie
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
NCT04657068 · Advanced Cancer, Metastatic Cancer,
Ovarian Cancer RecruitingThis clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to: * Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan * Learn more about the side effects of ART0380 alone and in combination with gemcitabine or irinotecan * Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or irinotecan
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 78 more
SponsorArtios Pharma Ltd
▾Tap for detailsClick for full details — eligibility, all locations, contacts Sample Collection for Ongoing Research and Product Evaluation Study
NCT07318051 ·
Breast Cancer,
Lung Cancer, Muscle Invasive Bladder Cancer
RecruitingThe SCORE study is a prospective, multi-site clinical trial designed to collect blood and tissue samples, along with relevant clinical data, from participants diagnosed with various solid tumors. The collected specimens and information will be used to evaluate the clinical performance of Natera's molecular residual disease (MRD) testing across multiple cancer types. The study aims to assess the ability of Natera's assays to detect circulating tumor DNA (ctDNA) as a marker for disease recurrence and treatment response.
Phase—
TypeObservational
Age18 Years
WhereAustin, Texas, United States
SponsorNatera, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
NCT05932862 · Advanced Solid Tumor
RecruitingThis is a first-in-human (FIH), multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as pharmacokinetics (PK) and pharmacodynamics of XL309 (previously ISM3091) administered alone or in combination with olaparib in participants with advanced solid tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WhereFountain Valley, California, United States + 15 more
SponsorExelixis
▾Tap for detailsClick for full details — eligibility, all locations, contacts