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 A Clinical Study of Calderasib (MK-1084) With Targeted Therapy and Chemotherapy in People With Colorectal Cancer (MK-1084-012/KANDLELIT-012)
NCT06997497 · Colon Adenocarcinoma, Rectal Adenocarcinoma
RecruitingResearchers are looking for other ways to treat locally advanced or metastatic colorectal cancer (mCRC) that is unresectable and has a gene mutation called KRAS G12C. Standard (or usual) treatments for this type of colorectal cancer may include mFOLFOX6 with or without bevacizumab. Researchers want to learn if adding calderasib (the study medicine) and cetuximab to mFOLFOX6 can treat locally advanced or mCRC with the KRAS G12C mutation. Calderasib and cetuximab are targeted therapies. The goals of this study are to learn: * About the safety of calderasib with cetuximab and mFOLFOX6 and if people tolerate the treatments * If people who receive calderasib with cetuximab and mFOLFOX6 live longer without mCRC growing or spreading compared to people who receive mFOLFOX6 with or without bevacizumab.
PhasePhase 3
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 235 more
SponsorMerck Sharp & Dohme LLC
▾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 Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays
NCT07283939 · Ampulla of Vater Carcinoma, Appendix Carcinoma, Carcinoma of Unknown Primary With Gastrointestinal Profile
RecruitingThis study seeks to learn whether using the PAGODA algorithm to guide chemotherapy dosing will lower the chance of unplanned delays during chemotherapy for cancer in the gastrointestinal system compared to usual care.
PhaseNA
TypeInterventional
Age18 Years
WhereFairbanks, Alaska, United States + 363 more
SponsorAlliance for Clinical Trials in Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts Immune Checkpoint Inhibitor Response in Solid Tumors Using a Live Tumor Diagnostic Platform
NCT06349642 · Early Stage Triple-Negative Breast Carcinoma, Metastatic Bladder Urothelial Carcinoma, Metastatic Cervical Carcinoma
RecruitingThis study is being done to collect tissue samples to test how accurately a tumor response platform, Elephas, can predict clinical response across multiple types of immunotherapies, chemoimmunotherapy and tumor types.
Phase—
TypeObservational
Age18 Years
WherePhoenix, Arizona, United States + 2 more
SponsorMayo Clinic
▾Tap for detailsClick for full details — eligibility, all locations, contacts An Investigational Drug (TPST-1495) in Patients With Familial Adenomatous Polyposis
NCT06557733 · Colorectal Carcinoma, Familial Adenomatous Polyposis
RecruitingThis open-label phase II trial tests how well TPST-1495 works in reducing the number of polyps in the small bowel and colon in patients with familial adenomatous polyposis (FAP). FAP is an inherited condition in which numerous polyps (growths that protrude from mucous membranes) form on the inside walls of the colon and rectum. It increases the risk for colon cancer. TPST-1495 binds to specific prostaglandin receptors. TPST-1495 is a dual antagonist of the prostaglandin E2 (PGE2) receptor subtypes EP2 and EP4, while sparing the immune-stimulating EP1 and EP3 receptors. TPST-1495 may help reduce the number of polyps in the small bowel and colon in patients with FAP.
PhasePhase 2
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 3 more
SponsorNational Cancer Institute (NCI)
▾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 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 A Study to Investigate ALE.P03 as Monotherapy in Adult Patients With Selected Advanced or Metastatic CLDN1+ Solid Tumors
RecruitingThe purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic, preliminary anti-tumor activity, and to determine the recommended Phase II dose (RP2D) of the ALE.P03 monotherapy in adult patients with selected squamous solid tumors.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 40 more
SponsorAlentis Therapeutics AG
▾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 KO-2806 Monotherapy and Combination Therapies in Advanced Solid Tumors
RecruitingThis first-in-human (FIH) dose-escalation and dose-validation/expansion study will assess KO-2806, a farnesyltransferase inhibitor (FTI), as a monotherapy and in combination, in adult patients with advanced solid tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 37 more
SponsorKura Oncology, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Testing the Addition of Total Ablative Therapy to Usual Systemic Therapy Treatment for Limited Metastatic Colorectal Cancer, ERASur Trial
NCT05673148 · Metastatic Colorectal Adenocarcinoma,
Stage IV Colorectal Cancer AJCC v8, Oligometastatic Colorectal Carcinoma
RecruitingThis phase III trial compares the addition of total ablative therapy to the usual systemic therapy versus the usual systemic therapy alone in treating patients with advanced colorectal cancer that has spread to up to 4 body sites (limited metastatic). The usual approach for patients who are not participating in a study is treatment with intravenous (through a vein) and/or oral medications (systemic therapy) to help stop the cancer sites from getting larger and the spread of the cancer to additional body sites. The ablative local therapy will consist of any combination of very focused, intensive radiotherapy called stereotactic ablative radiotherapy (SABR), surgical resection, or microwave ablation, which is a procedure where a needle is temporarily inserted in the tumor and heat is used to destroy the cancer cells. The addition of ablative local therapy to the usual approach of systemic therapy could be more effective than usual chemotherapy alone by increasing the life of patients with limited metastatic colorectal cancer.
PhasePhase 2
TypeInterventional
Age18 Years
WhereKingman, Arizona, United States + 186 more
SponsorAlliance for Clinical Trials in Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Activity of CBI-1214 T Cell Engager in Participants With Advanced or Metastatic MSS/MSI-L Colorectal Cancer
NCT07321106 ·
Colorectal Cancer,
Colorectal Cancer (CRC), Colorectal (Colon or Rectal) Cancer
RecruitingThis study will investigate the safety, tolerability, pharmacokinetics, and anti-tumor activity of CBI-1214 in participants with advanced or metastatic Microsatellite Stable (MSS)/Microsatellite Instability Low (MSI-L) Colorectal Cancer
PhasePhase 1
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 9 more
SponsorCartography Biosciences
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of XmAb®819 in Subjects With Advanced Clear Cell Renal Cell Carcinoma
NCT05433142 · Clear Cell Renal Cell Carcinoma
RecruitingThe purpose of this study is to assess the safety and tolerability of XmAb®819 administered intravenous (IV) or subcutaneous (SC) in subjects with relapsed or refractory clear cell renal cell carcinoma and to identify the minimum safe and biologically active dose and the recommended dose (RD).
PhasePhase 1
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 25 more
SponsorXencor, Inc.
▾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 This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), preliminary antitumor activity, and effect of biomarkers of zanzalintinib administered alone, and in combination with nivolumab (doublet), nivolumab + ipilimumab (triplet) and nivolumab + relatlimab (triplet) and in combination with docetaxel and prednisone in participants with advanced solid tumors. In addition, the study will evaluate the effect of multiple dose administration of zanzalintinib on the single-dose pharmacokinetics of sensitive CYP3A4, CYP2C9, CYP2C19, or CYP1A2 substrates in participants with advanced solid tumors. In the Expansion Stage, the safety and efficacy of zanzalintinib as monotherapy and in combination therapy will be further evaluated in tumor-specific Expansion Cohorts.
PhasePhase 1
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 121 more
SponsorExelixis
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of Orally Administered MOMA-341 in Participants With Advanced or Metastatic Solid Tumors
NCT06974110 · Advanced Solid Tumor, Metastatic Solid Tumor, Endometrial Cancer
RecruitingThis Phase 1, multi-center, open-label, dose escalation and dose optimization study is designed to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and preliminary clinical activity of MOMA-341 administered orally as a single agent or combination therapy in patients with microsatellite instability high (MSI-H) or DNA mismatch repair deficiency (dMMR) solid tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 14 more
SponsorMOMA Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
RecruitingThis Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.
PhasePhase 2 / Phase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 1076 more
SponsorNRG Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
RecruitingObjective: To collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment. Design: This is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.
Phase—
TypeObservational
Age18 Years
WhereGilbert, Arizona, United States + 15 more
SponsorA2 Biotherapeutics Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts