CT-95 in Advanced Cancers Associated With Mesothelin Expression
NCT06756035 · Mesothelin-Expressing Tumors, Epithelial Ovarian Cancer, Malignant Pleural Mesothelioma, Advanced
RecruitingThis is a Phase 1a/1b open-label, dose escalation study to evaluate the safety and efficacy of CT-95 (study drug), a humanized T cell engaging bispecific antibody targeting Mesothelin, in subjects with advanced solid tumors associated with Mesothelin expression.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDenver, Colorado, United States + 7 more
SponsorContext Therapeutics Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Fruquintinib Plus FOLFIRI as Second-Line Treatment for Participants With Metastatic Colorectal Cancer (mCRC)
NCT07011576 · Colon Cancer, Rectal Cancer, Colorectal Cancer
RecruitingThis is an open-label multicenter, single-arm Phase II study of Fruquintinib in combination with FOLFIRI (leucovorin calcium (folinic acid), fluorouracil, and irinotecan) in participants with metastatic colorectal cancer (mCRC). The main goals of this study are to: * Evaluate the efficacy of the combination of fruquintinib + FOLFIRI in the 2nd-line mCRC setting * Evaluate the safety of the combination of fruquintinib + FOLFIRI
PhasePhase 2
TypeInterventional
Age18 Years
WhereDenver, Colorado, United States + 13 more
SponsorSCRI Development Innovations, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of IDE196 in Patients With Solid Tumors Harboring GNAQ/11 Mutations or PRKC Fusions
NCT03947385 · Metastatic Uveal Melanoma, Cutaneous Melanoma, Colorectal Cancer
RecruitingThis is a Phase 1/2, multi-center, open-label basket study designed to evaluate the safety and anti-tumor activity of IDE196 in patients with solid tumors harboring GNAQ or GNA11 (GNAQ/11) mutations or PRKC fusions, including metastatic uveal melanoma (MUM), cutaneous melanoma, colorectal cancer, and other solid tumors. Phase 1 (dose escalation - monotherapy) will assess safety, tolerability and pharmacokinetics of IDE196 via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Phase 1 (dose escalation - binimetib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and binimetinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Phase 1 (dose escalation - crizotinib combination) will assess safety, tolerability and pharmacokinetics of IDE196 and crizotinib via standard dose escalation scheme and determine the recommended Phase 2 dose. Safety and anti-tumor activity will be assessed in the Phase 2 (dose expansion) part of the study. Evaluation of safety and efficacy across multiple doses may be explored in the dose optimization part of the study. Crizotinib monotherapy with crossover to combination cohort may be assessed for safety and to show the contribution of each study drug to anti-tumor activity. As of Protocol Amendment 10, Phase 1, Phase 2 dose expansion in IDE196 monotherapy, and Phase 2 dose expansion of IDE196 in combination with binimetinib have been fully enrolled. There were no patients enrolled in the crizotinib monotherapy cohorts.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 14 more
SponsorIDEAYA Biosciences
▾Tap for detailsClick for full details — eligibility, all locations, contacts Pre- and Post-operative TEG Indices in Patients With or Without Adenocarcinoma Undergoing Surgical Resection
NCT05517811 · Liver Cancer, Esophageal Cancer, Colorectal Cancer
RecruitingThe investigators hypothesize that abnormalities in thromboelastography (TEG) parameters in patients with liver, pancreas, biliary, esophageal, colorectal, and lung adenocarcinoma can serve as biomarkers for oncologic disease burden, cancer recurrence and overall survival as well as thrombotic and hemorrhagic post-operative complications. The investigators further hypothesize that there is histologic pathology correlates to pre-operative TEG abnormalities, and that it identifies patients with virulent tumor biology.
Phase—
TypeObservational
Age18 Years – 99 Years
WhereAurora, Colorado, United States
SponsorUniversity of Colorado, Denver
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase 1-2 of ST316 With Selected Advanced Unresectable and Metastatic Solid Tumors
NCT05848739 · Colon Cancer, Metastatic Colon Cancer
RecruitingThis is an open-label, two-part, phase 1-2 study designed to determine the safety, tolerability, PK, pharmacodynamics (PD), and proof-of-concept efficacy of ST316 administered IV in subjects with selected advanced solid tumors likely to harbor abnormalities of the WNT/β-catenin signaling pathway. The study consists of two phases: a phase 1 dose escalation/regimen exploration phase and a phase 2 expansion phase.
PhasePhase 1
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 10 more
SponsorSapience Therapeutics
▾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
NCT05334069 · Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Ann Arbor Stage I Lymphoma
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 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 or in combination with cetuximab? * Does KQB365 alone or in combination with cetuximab decrease the size of the tumor? * What happens to KQB365 in the body? Participants will: * Receive KQB365 infusion weekly alone or in combination with cetuximab * 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 + 8 more
SponsorKumquat Biosciences Inc.
▾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 Exogenous and Endogenous Risk Factors for Early-onset Colorectal Cancer
NCT05732623 · Colorectal Cancer, Early Onset Colorectal Cancer, Diet Habit
RecruitingAn increase in early-onset colorectal cancers (eoCRC), defined as a CRC before 50 years, is confirmed globally. CRC pathogenesis has been associated with several risk factors (family history, germline pathogenic variants, obesity, alcohol, physical activity, red meat, and a Western diet). Design: an international, multicenter, retrospective case-control study of prospectively enrolled patients; low-risk intervention study as it will perform a fecal occult blood test Endpoint: predictive power of a semi-quantitative food frequency questionnaire (SQFFQ) developed for eoCRC. Cases: Patients with a recent diagnosis of eoCRC (within 2 years from enrollment). Controls: matched by age (matching range ± 5 years) and sex. Healthy volunteers will be mainly enrolled among workers within the participating hospital center. The enrolled healthy volunteers will perform a fecal occult blood test. Variables of interest: age, sex, ethnicity, BMI at the time of eoCRC diagnosis and at 18 years old, country, tobacco smoking at the time of eoCRC diagnosis and at 18 years old, sitting time, TV-viewing time, moderate-to-vigorous physical activity (MVPA), waist circumference (cm), home blood pressure levels (mmHg), fasting blood glucose (mg/dl), regular consumption of aspirin/NSAID, calcium and folate supplements, oral contraceptive agents, post-menopausal hormones and years of consumptions, if the filled questionnaire reflects diet for the last 5-10 years before. Cases only: date of eoCRC diagnosis, symptoms at diagnosis, eoCRC localization, eoCRC stage, histological diagnosis, type of surgery, and date (if performed), chemotherapy and radiotherapy (if performed), vital status and duration of follow-up, family history of CRC and other cancers (uterus, ovary, stomach, small intestine, urinary tract/bladder/kidney, bile ducts, brain, pancreas, skin tumors), type of germline pathogenetic variant (if performed). Before the case-control study, three non-consecutive 24-hour Dietary Recalls (24hDRs) will validate the SQFFQ. The SQFFQ will be administered to the validation study group during three non-consecutive calls, including one non-weekday (30-minute 24-h-recall computer-aided personal interview). Primary Objective To measure the relative risk of specific dietary and lifestyle factors (smoking habit, alcohol intake, physical activity) for early-onset colorectal cancer in countries where eoCRC incidence is increasing versus stable/decreasing
Phase—
TypeObservational
Age18 Years – 49 Years
WhereDenver, Colorado, United States + 7 more
SponsorSan Raffaele University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors
NCT06239194 · Biliary Tract Cancer, Breast Cancer, Cervical Cancer
RecruitingThis study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereDenver, Colorado, United States + 5 more
SponsorModeX Therapeutics, An OPKO Health Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
NCT05253651 · Colorectal Neoplasms
RecruitingThis study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable). Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either: * mFOLFOX6 alone, * mFOLFOX6 with bevacizumab, or * mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.
PhasePhase 3
TypeInterventional
Age18 Years
WhereGlendale, Arizona, United States + 381 more
SponsorSeagen, a wholly owned subsidiary of Pfizer
▾Tap for detailsClick for full details — eligibility, all locations, contacts Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
NCT05080673 · Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
RecruitingThis trial examines colorectal cancer incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.
PhaseNA
TypeInterventional
Age45 Years – 70 Years
WhereFairbanks, Alaska, United States + 479 more
SponsorNRG Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors
NCT06586515 · Pancreatic Ductal Adenocarcinoma, Non-small Cell Lung Cancer, Colorectal Cancer
RecruitingThe main purpose of this study is to assess safety \& tolerability and antitumor activity of LY3962673 as monotherapy and in combination with other chemotherapy agents in participants with KRAS G12D-mutant advanced solid tumor types. The study is expected to last approximately 5 years.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 51 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of JNJ-89402638 for Metastatic Colorectal and Gastric Cancers
NCT06663319 · Colorectal Neoplasms, Gastrointestinal Neoplasms
RecruitingThe purpose of this study is to determine the putative recommended phase 2 dose(s) (RP2Ds) of JNJ-89402638 and to determine the safety of JNJ-89402638 at the RP2D(s) in participants with metastatic colorectal cancer (mCRC) and metastatic gastric cancer (mGAC) and to determine the safety and tolerability of JNJ-89402638 in combination with bevacizumab or biosimilar with or without chemotherapy in participants with mCRC.
PhasePhase 1
TypeInterventional
Age18 Years
WhereAurora, Colorado, United States + 9 more
SponsorJanssen Research & Development, LLC
▾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 Evaluate INCB161734 in Participants With Advanced or Metastatic Solid Tumors With KRAS G12D Mutation
NCT06179160 · Solid Tumors
RecruitingThis study is conducted to determine the safety and tolerability of INCB161734 as a single agent or in combination with other anticancer therapies.
PhasePhase 1
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 33 more
SponsorIncyte Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of STRO-004 in Adults With Refractory/Recurrent Metastatic Cancer
NCT07227168 · Head and Neck Squamous Cell Carcinoma HNSCC, Non-Small Cell Lung Cancer NSCLC, Esophageal Cancer
RecruitingThis is a study to evaluate the safety and preliminary anti-tumor activity of STRO-004 in adults with metastatic cancer. This study includes 3 parts: * Part 1A is a dose escalation study of STRO-004 monotherapy in selected tumor types known to commonly express Tissue Factor (TF). * Part 1B is a cohort expansion in 1 or more types of cancer to further evaluate a STRO-004 monotherapy dose, determine the best dose for use in later phases, and examine anti-tumor activity. * Part 1C is a dose escalation of STRO-004 combined with pembrolizumab to determine tolerability and preliminary anti-tumor activity of both drugs used together.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDenver, Colorado, United States + 5 more
SponsorSutro Biopharma, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of MRG007 (ARR-217) in Patients With Advanced Solid Tumors
NCT07066657 · Locally Advanced or Metastatic Solid Tumors, Colorectal Cancer, Gastric Cancer
RecruitingThis is an open-label, multi-center, phase I study to evaluate the safety, tolerability, efficacy, and pharmacokinetics of MRG007 (ARR-217) in patients with unresectable locally advanced or metastatic solid tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 14 more
SponsorArriVent BioPharma, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts LOTUS-CC: An Observational Research Study to Uncover Subtypes of Cancer Cachexia
NCT06073431 · Advanced Colorectal Carcinoma, Advanced Lung Non-Small Cell Carcinoma, Advanced Pancreatic Adenocarcinoma
RecruitingThis study evaluates cancer-related weight and muscle mass loss, symptoms, and physical function (cachexia) in patients undergoing treatment for colorectal, lung, or pancreatic cancer that cannot be removed by surgery (unresectable) or is stage IV. Patients with these cancer types are at risk for developing cancer cachexia (CC), which is defined as weight loss, muscle loss, and fat loss due to cancer. CC has been associated with reduced physical performance, impaired quality of life, and poorer survival. Many studies that have evaluated treatments for cancer-related weight and muscle loss have aimed to treat all patients with weight loss exactly the same and, unfortunately, have not been successful. Like different cancer types, weight and muscle loss related to cancer may have different causes in different individuals and the best treatment strategy for this condition may not be a one-size-fits-all approach. Information gathered from this study may help researchers develop new diagnostic criteria for CC and design better treatments and clinical trials for cancer-related weight and muscle loss in the future to improve the quality of life in patients with advanced colorectal, lung, or pancreatic cancer.
Phase—
TypeObservational
Age18 Years
WhereFort Smith, Arkansas, United States + 224 more
SponsorUniversity of Rochester
▾Tap for detailsClick for full details — eligibility, all locations, contacts Improving Adolescent and Young Adult Self-Reported Data in ECOG-ACRIN Trials
NCT05108298 · Breast Cancer, NOS, CNS Primary Tumor, NOS, Cervical Cancer, NOS
RecruitingThe purpose of this study is to evaluate feasibility and acceptability of completing PROs among AYAs randomized to Choice PRO vs Fixed PRO.
PhaseNA
TypeInterventional
Age18 Years – 39 Years
WhereFairbanks, Alaska, United States + 346 more
SponsorEastern Cooperative Oncology Group
▾Tap for detailsClick for full details — eligibility, all locations, contacts