Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors
NCT06445062 ·
Colorectal Cancer, CRC, Pancreatic Ductal Adenocarcinoma
RecruitingThe purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents. The current subprotocols include the following: Subprotocol A: RMC-6236 + 5-fluorouracil-based regimens Subprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel Subprotocol D: RMC-9805 with or without RMC-6236 + 5-fluorouracil-based regimens Subprotocol E: RMC-9805 with or without RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol F: RMC-9805 with or without RMC-6236 + gemcitabine + nab-paclitaxel
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereChandler, Arizona, United States + 31 more
SponsorRevolution Medicines, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts AMG 410 Alone and in Combination With Other Agents in Participants With KRAS Altered Advanced or Metastatic Solid Tumors
NCT07094113 · KRAS Altered Advanced or Metastatic Solid Tumors
RecruitingThe purpose of this first-in-human study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of AMG 410 when administered alone or in combination with other agents in participants with advanced or metastatic solid tumors harboring KRAS alterations. This is a dose-escalation study in which participants will be assigned to multiple dose levels (DLs) of AMG 410, either as monotherapy or in combination with other agents, followed by expansion cohorts. The goal is to determine the Maximum Tolerated Dose (MTD)-the highest dose with acceptable safety and manageable side effects-or the Recommended Phase 2 Dose (RP2D) of AMG 410 in adult participants with KRAS-altered advanced or metastatic solid tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 38 more
SponsorAmgen
▾Tap for detailsClick for full details — eligibility, all locations, contacts Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years
NCT04373564 · Motor Function, Cognitive Function, Contrast Media
RecruitingThis study is a postmarketing requirement jointly carried out by four NDA holders (Bayer AG, Bracco, GE Healthcare and Guerbet) and the CRO IQVIA. The study aims to create detailed images of the organs and tissue of the human body during x-ray, CT-scan or MRI investigations, doctors are using contrast media (a kind of dye) which can be given to patients by injection into a blood vessel or by mouth. In this study researchers want to find out whether so called gadolinium-based contrast agents (GBCAs) have an effect on body movement and mental skills when given to participants multiple times within 5 years. The study plans to enroll about 2076 participants suffering from a condition for which they are likely to have at least annually a MRI or another imaging examinations. Only adults up to 65 years will be considered to join this study. During the study duration of 5 years participants will receive annually a MRI or other imaging tests (such as CT-scan, x-ray) and will visit the study doctor at least 7 times for physical examinations, laboratory investigations and tests on body movement and mental skills.
PhasePhase 4
TypeInterventional
Age18 Years – 64 Years
WhereScottsdale, Arizona, United States + 50 more
SponsorGuerbet
▾Tap for detailsClick for full details — eligibility, all locations, contacts Phase 1 Study to Investigate TCRTs KRAS Mutation in Unresectable, Advanced, and/or Metastatic Solid Tumors
NCT06218914 ·
Non-small Cell Lung Cancer, Colorectal Carcinoma, Pancreatic Ductal Adenocarcinoma
RecruitingPhase I Study, a master protocol to investigate TCR-Engineered T cells recognizing KRAS mutations in adult subjects with Unresectable, Advanced, and/or Metastatic Solid Tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 17 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors
NCT06244771 · Advanced Solid Tumors With KRAS G12C Mutations, Solid Tumor, Adult, Unresectable Solid Tumor
RecruitingThe goal of this clinical trial is to evaluate FMC-376 in participants with advanced solid tumors with KRAS G12C mutations. This clinical trial will be conducted in 3 parts: Phase 1A (Dose Escalation), Phase 1B (Dose Expansion), and Phase 2 (Cohort Expansion). Multiple dose levels in participants with advanced solid tumors will be evaluated.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereLa Jolla, California, United States + 25 more
SponsorFrontier Medicines Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Assess Adverse Events and Change in Disease Activity in Adult Participants Receiving Intravenously Infused Telisotuzumab Adizutecan Alone or With Standard of Care in Participants With Post Adjuvant Circulating Tumor DNA Positive Colorectal Cancer and No Radiographic Evidence of Disease
RecruitingColorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess change in disease activity when telisotuzumab adizutecan is given alone compared to standard of care (SOC) given alone. Telisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. This study will be divided into two groups called treatment arms. In arm 1 participants will receive telisotuzumab adizutecan alone. In arm 2 participants will receive SOC alone. Approximately 140 adult participants with CRC will be enrolled in the study in 45 sites worldwide. In arm 1, participants will receive intravenous (IV) doses of telisotuzumab adizutecan alone. In arm 2 Participants will receive SOC alone. The study will run for a duration of approximately 51 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 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 2
TypeInterventional
Age18 Years
WhereHuntsville, Alabama, United States + 47 more
SponsorAbbVie
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of LY4337713 in Participants With FAP-Positive Solid Tumors
NCT07213791 · Ovarian Neoplasms, Breast Neoplasms, Pancreatic Intraductal Neoplasms
RecruitingThis is a study of LY4337713 in participants with certain types of cancer that is advanced or has spread. Participants must have cancer with high levels of a protein called fibroblast activation protein (FAP). The purpose of this study is to evaluate safety, side effects, and efficacy of LY4337713. In addition, this study will evaluate how much LY4337713 gets into the bloodstream, how it is broken down, and how long it takes the body to get rid of it. For each participant, the study will last about 5 years.
PhasePhase 1
TypeInterventional
Age18 Years
WhereNewport Beach, California, United States + 29 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts Testing Pump Chemotherapy in Addition to Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone for Patients With Unresectable Colorectal Liver Metastases: The PUMP Trial
NCT05863195 · Metastatic Colorectal Carcinoma, Metastatic Malignant Neoplasm in the Liver,
Stage IV Colorectal Cancer AJCC v8 RecruitingThis phase III trial compares hepatic arterial infusion (HAI) (pump chemotherapy) in addition to standard of care chemotherapy versus standard of care chemotherapy alone in treating patients with colorectal cancer that has spread to the liver (liver metastases) and cannot be removed by surgery (unresectable). HAI uses a catheter to carry a tumor-killing chemotherapy drug called floxuridine directly into the liver. HAI is already approved by the Food and Drug Administration (FDA) for use in metastatic colorectal cancer to the liver, but it is only available at a small number of hospitals, and most of the time it is not used until standard chemotherapy stops working. Standard chemotherapy drugs work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding HAI to standard chemotherapy may be effective in shrinking or stabilizing unresectable colorectal liver metastases.
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 61 more
SponsorECOG-ACRIN Cancer Research Group
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Novel Study Interventions and Combinations in Participants With Colorectal Cancer
RecruitingThe main purpose of this study is to evaluate the safety and efficacy of novel study interventions and combinations in participants with Colorectal Cancer (CRC).
PhasePhase 2
TypeInterventional
Age18 Years – 130 Years
WhereScottsdale, Arizona, United States + 75 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of CP-383 in Patients With Advanced or Metastatic Solid Tumors
NCT07030257 · Solid Tumor Malignancies, Colorectal Carcinoma,
Small Cell Lung Cancer ( SCLC ) RecruitingThe goal of this clinical trial is to learn if an investigational drug CP-383 works to treat advanced cancer. It will also learn about the safety of CP-383. The main questions if aims to answer are: * Does CP-383 slow or stop the growth of cancer in patients with advanced cancer * What medical problems do participants have when taking CP-383 Researchers will test CP-383 in all kinds of cancers at various dose levels to determine what the best dose is to study further. Researchers will also see if certain cancers that have gene mutations respond better to CP-383 Participants will: * Take CP-383 every day by mouth until the researcher learns whether CP-383 is helping slow or reduce the cancer growth * Visit the clinic weekly for the first 6 weeks for checkups and tests * Visit the clinic every 3 weeks thereafter for checkups and tests
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereDenver, Colorado, United States + 12 more
SponsorTasca Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Investigate the Safety and Efficacy of KQB365 as Monotherapy and in Combination in Participants With Advanced Solid Malignancies
NCT06720987 · KRAS G12C Mutation, KRAS G12S Mutation, Solid Tumor Malignancies
RecruitingThe goal of this clinical trial is to learn if KQB365 works to treat advanced solid tumor cancer in adults. It will also learn about the safety of KQB365. The main questions it aims to answer are: * What is the safe dose of KQB365 by itself, in combination with cetuximab, or in combination with KQB198? * Does KQB365 alone, in combination with cetuximab, or in combination with KQB198 decrease the size of the tumor? * What happens to KQB365 in the body? Participants will: * Receive KQB365 infusion weekly alone, in combination with cetuximab, or in combination with oral KQB198. * Visit the clinic about 9 times in the first 6 weeks, and then once every week after that.
PhasePhase 1
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 10 more
SponsorKumquat Biosciences Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Safety and Efficacy of Two Dose Levels of ONO-4578 With Opdivo®, in Combination With mFOLFOX6 and Bevacizumab Versus Standard of Care in Participants With Non-MSI-H/dMMR, PD-L1 Positive Advanced Colorectal Cancer
RecruitingThe purpose of this study is to evaluate the safety and efficacy of two dose levels of ONO-4578 with Opdivo® when added to mFOLFOX6 and bevacizumab versus SOC as first-line treatment for advanced CRC.
PhasePhase 2
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 38 more
SponsorOno Pharmaceutical Co., Ltd.
▾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 The Cancer of the Pancreas Screening-5 CAPS5)Study
NCT02000089 · Pancreas Cancer, Peutz-Jeghers Syndrome (PJS), Gene Mutation
RecruitingJohns Hopkins clinical research office quality assurance group will monitor and audit this study at Johns Hopkins. The Sub Investigator at each site will be responsible for internal monitoring at their site.
PhasePhase 3
TypeInterventional
Age18 Years
WhereNew Haven, Connecticut, United States + 8 more
SponsorJohns Hopkins University
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populations With Advanced, Previously Treated Colorectal Cancer
RecruitingHigh blood pressure (hypertension) is a known side effect of the treatment with fruquintinib. Current research does not provide a clear answer whether minority groups such as Black/African American and/or Hispanic/Latino with refractory metastatic colorectal cancer (mCRC) have a bigger risk of higher blood pressure after treatment with fruquintinib. The main aim of this study is to learn how often adults of a minority group experience hypertension after they have been treated with fruquintinib for refractory mCRC. Other aims are to learn how safe fruquintinib is and how well it is tolerated by participants. Participants will receive fruquintinib in 4-week treatment cycles until their condition worsens, they do no longer tolerate the treatment or stop the treatment for other reasons. After the last treatment, participants will be checked upon every 3 months until study completion.
PhasePhase 4
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 44 more
SponsorTakeda
▾Tap for detailsClick for full details — eligibility, all locations, contacts Phase III Study of Ivonescimab or Bevacizumab Combined With FOLFOX in Patients With Metastatic Colorectal Cancer
RecruitingA Randomized, Active-Controlled, Double-blind, Multicenter, Phase 3 Clinical Study of Ivonescimab in Combination with mFOLFOX6 (Oxaliplatin, Leucovorin and 5-Fluorouracil) versus Bevacizumab in Combination with FOLFOX for the First-line Treatment of Metastatic Colorectal Cancer(HARMONi-GI3)
PhasePhase 3
TypeInterventional
Age18 Years
WhereMobile, Alabama, United States + 212 more
SponsorSummit Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase 1/2 Study to Evaluate CHM-2101, an Autologous Cadherin 17 Chimeric Antigen Receptor (CAR) T Cell Therapy
NCT06055439 · Neuroendocrine Tumors,
Colorectal Cancer, Gastric Cancer
RecruitingThe goal of this clinical trial is to evaluate CHM-2101, an autologous CDH17 CAR T-cell therapy for the treatment of advanced gastrointestinal (GI) cancers that are relapsed or refractory to at least 1 standard treatment regimen in the metastatic or locally advanced setting.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years – 85 Years
WhereAtlanta, Georgia, United States + 3 more
SponsorChimeric Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
NCT03659448 · Colorectal Neoplasms
RecruitingThe performance of SGM-101, an intraoperative imaging agent, will be compared to that of standard "white light" visualization during surgical resections of colorectal cancer.
PhasePhase 3
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 10 more
SponsorSurgimab
▾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 The goal of this clinical trial is to determine if FOG-001 is safe and effective in participants with locally advanced or metastatic solid tumors or in participants with familial adenomatous polyposis (FAP).
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 32 more
SponsorParabilis Medicines, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts