A Study to Learn More About How Well Treatment With Sevabertinib (BAY 2927088) Tablets Works and How Safe it is in Participants Who Have a Solid Tumor With Mutations of the Human Epidermal Growth Factor Receptor 2 (HER2)
NCT06760819 · Advanced Solid Tumors, HER2 Mutation
RecruitingResearchers are looking for a better way to treat people who have solid tumors with HER2-activating mutations. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works. In this trial, the researchers want to learn how well BAY2927088 (sevabertinib) works in people with different types of solid tumors with HER2 mutations. These include tumors in the colon or rectum, the uterus and the cervix (lower part of the uterus), the breast, the bladder, and the biliary tract (includes gall bladder and bile ducts) as well as other types of solid tumors with the exception of people with advanced non-small cell lung cancer (NSCLC). Solid tumors may have specific changes or mutations to a gene called human epidermal growth receptor-2 (HER2). This leads to the formation of an abnormal form of HER2 protein in the cancer cells, resulting in increased cell growth. The study treatment, BAY2927088, is expected to block the abnormal HER2 protein which may stop the spread of cancer. The trial will include about 111 participants who are at least 18 years old. All the participants will take 20 mg of BAY2927088 as tablets by mouth. The participants will take treatments in 3-week periods called cycles. These 3-week cycles will be repeated throughout the trial. The participants can take BAY2927088 until their cancer gets worse, until they have medical problems, or until they leave the trial. During the trial, the doctors will take imaging scans of different parts of the body to study the spread of cancer and will check heart health using echocardiogram or cardiac magnetic resonance imaging (MRI) and electrocardiogram (ECG). The doctors will also take blood and urine samples and do physical examinations to check the participants' health. They will ask questions about how the participants are feeling and if they have any medical problems.
PhasePhase 2
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 53 more
SponsorBayer
▾Tap for detailsClick for full details — eligibility, all locations, contacts Samuraciclib for the Treatment of Patients With Resectable, Borderline Resectable, or Locally Advanced Basal Pancreatic Cancer
NCT07645651 · Resectable Pancreatic Ductal Adenocarcinoma, Borderline Resectable Pancreatic Ductal Adenocarcinoma, Locally Advanced Pancreatic Ductal Adenocarcinoma
RecruitingThe purpose of this study is to evaluate the safety and efficacy of samuraciclib in patients with localized pancreatic cancer.
PhasePhase 1
TypeInterventional
Age18 Years
WhereSeattle, Washington, United States
SponsorUniversity of Washington
▾Tap for detailsClick for full details — eligibility, all locations, contacts Testing the Use of Chemotherapy After Surgery for High-Risk Pancreatic Neuroendocrine Tumors
NCT05040360 · Metastatic Malignant Neoplasm in the Liver, Pancreatic Neuroendocrine Tumor, Stage I Pancreatic Neuroendocrine Tumor AJCC v8
RecruitingThis phase II trial studies the effect of capecitabine and temozolomide after surgery in treating patients with high-risk well-differentiated pancreatic neuroendocrine tumors. Chemotherapy drugs, such as capecitabine and temozolomide, 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. Giving capecitabine and temozolomide after surgery could prevent or delay the return of cancer in patients with high-risk well-differentiated pancreatic neuroendocrine tumors.
PhasePhase 2
TypeInterventional
Age18 Years
WhereAnchorage, Alaska, United States + 447 more
SponsorSWOG Cancer Research Network
▾Tap for detailsClick for full details — eligibility, all locations, contacts BBO-11818 in Adult Subjects With KRAS Mutant Cancer
NCT06917079 ·
Non-Small Cell Lung Cancer, NSCLC, PDAC - Pancreatic Ductal Adenocarcinoma
RecruitingA first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 16 more
SponsorTheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
▾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 + 20 more
SponsorArriVent BioPharma, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of BMS-986504 Monotherapy and in Combination With Other Agents in Participants With Advanced and/or Metastatic Solid Tumors With Homozygous MTAP Deletion (MountainTAP-5)
NCT07492680 · Solid Tumors
RecruitingThis is an open-label, multicenter Phase 2 study evaluating BMS-986504 in participants with advanced and/or metastatic solid tumors that have MTAP deletion. The study includes a monotherapy component and a combination component in which BMS-986504 is given with other anti-cancer agents. The trial will assess the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary anti-tumor activity of BMS-986504 alone and in combination regimens.
PhasePhase 2
TypeInterventional
Age18 Years
WhereSan Francisco, California, United States + 56 more
SponsorBristol-Myers Squibb
▾Tap for detailsClick for full details — eligibility, all locations, contacts Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
NCT06943755 · Pancreatic Neuroendocrine Tumor (pNET), Extra-Pancreatic Neuroendocrine Tumor (epNET)
RecruitingThe primary purpose of this study is to assess the effectiveness of zanzalintinib compared to everolimus in participants with previously treated, unresectable, locally advanced or metastatic neuroendocrine tumors.
PhasePhase 2 / Phase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 125 more
SponsorExelixis
▾Tap for detailsClick for full details — eligibility, all locations, contacts Phase 1 Study of MRTX1719 in Solid Tumors With MTAP Deletion
NCT05245500 · Mesothelioma,
Non Small Cell Lung Cancer, Malignant Peripheral Nerve Sheath Tumors
RecruitingThis is a Phase 1, open-label, multicenter, study of the safety, tolerability, PK, PD, and anti-tumor activity of MRTX1719 patients with advanced, unresectable or metastatic solid tumor malignancy with homozygous deletion of the MTAP gene.
PhasePhase 1
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 24 more
SponsorBristol-Myers Squibb
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of RYZ101 Compared With SOC in Pts w Inoperable SSTR+ Well-differentiated GEP-NET That Has Progressed Following 177Lu-SSA Therapy
NCT05477576 · GEP-NET, Gastroenteropancreatic Neuroendocrine Tumor, Gastroenteropancreatic Neuroendocrine Tumor Disease
RecruitingThis study aims to determine the safety, pharmacokinetics (PK) and recommended Phase 3 dose (RP3D) of RYZ101 in Part 1, and the safety, efficacy, and PK of RYZ101 compared with investigator-selected standard of care (SoC) therapy in Part 2 in subjects with inoperable, advanced, well-differentiated, somatostatin receptor expressing (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that have progressed following treatment with Lutetium 177-labelled somatostatin analogue (177Lu-SSA) therapy, such as 177Lu-DOTATATE or 177Lu-DOTATOC (177Lu-DOTATATE/TOC), or 177Lu-high affinity \[HA\]-DOTATATE.
PhasePhase 3
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 53 more
SponsorRayzeBio, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase II Nationwide, Fully Decentralized, Telemedicine Study of Pemigatinib in Adult Patients With Advanced or Metastatic Pancreatic Cancer With FGFR Genetic Alterations
NCT06906562 · Advanced Pancreatic Carcinoma, Metastatic Pancreatic Carcinoma,
Stage II Pancreatic Cancer AJCC v8 RecruitingThis phase II study evaluates how well pemigatinib works for the treatment of adult patients with pancreatic cancer that has spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced) or has spread from where it first started to other places in the body (metastatic) and that have abnormal changes (alterations) in the fibroblast growth factor receptor (FGFR) gene. FGFR genes are genes that, when altered, can lead to and promote the growth of cancer in patients. Researchers want to test if using pemigatinib can block the function of these abnormal FGFR genes and prevent the tumor from growing and whether treatment can help improve overall quality of life.
PhasePhase 2
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 108 more
SponsorSameek Roychowdhury
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of Daraxonrasib and Daraxonrasib + GnP as First-line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
RecruitingThe purpose of this study is to evaluate the safety and efficacy of an investigational RAS(ON) inhibitor administered as monotherapy or in combination with chemotherapy, compared with standard of care (SOC) chemotherapy alone.
PhasePhase 3
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 48 more
SponsorRevolution Medicines, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of CLSP-1025 in Adult Patients With Solid Tumors That Harbor the p53 R175H Mutation
NCT06778863 · Advanced Solid Tumor, Unresectable Solid Tumor, Metastatic Solid Tumor
RecruitingPhase 1 dose escalation and expansion study of CLSP-1025, a first-in-class HLA-A\*02:01 specific T cell engager (TCE) targeting solid tumors that harbor the p53 R175H mutation.
PhasePhase 1
TypeInterventional
Age18 Years
WhereScottsdale, Arizona, United States + 20 more
SponsorClasp Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase 2 Study of VS-7375 in Patients With KRAS G12D-Mutated Pancreatic Cancer
NCT07644559 · Pancreatic Ductal Adenocarcinoma (PDAC), G12D Mutated KRAS
RecruitingThis study will assess the safety and efficacy of VS-7375 alone and in combination with cetuximab in patients with metastatic KRAS G12D - mutated Pancreatic Cancer
PhasePhase 2
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 28 more
SponsorVerastem, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts 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 Study of HER3-DXd in Subjects With Locally Advanced or Metastatic Solid Tumors
NCT06172478 · Advanced Solid Tumor,
Melanoma, Head and Neck Cancer
RecruitingThis is a proof-of-concept study designed to investigate HER3-DXd monotherapy in locally advanced unresectable or metastatic solid tumors. The study is enrolling cohorts of participants with melanoma \[cutaneous/acral\], squamous cell carcinomas of the head and neck (SCCHN), HER2-negative gastric cancer ovarian carcinoma, cervical cancer, endometrial cancer, bladder cancer, esophageal carcinoma, pancreatic carcinoma, prostate cancer, second-line gastric cancer, lung cancer, and breast cancer.
PhasePhase 2
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 89 more
SponsorDaiichi Sankyo
▾Tap for detailsClick for full details — eligibility, all locations, contacts This study will assess the safety and efficacy of VS-7375 alone and in combination in patients with advanced solid tumors harboring a KRAS G12D-mutation.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 13 more
SponsorVerastem, Inc.
▾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 Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
RecruitingThe purpose of this study is to evaluate the safety and efficacy of atebimetinib in combination with modified GnP compared with SOC GnP alone.
PhasePhase 3
TypeInterventional
Age18 Years
WhereHuntsville, Alabama, United States + 44 more
SponsorImmuneering Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Safety and Efficacy of Mesothelin-Targeting Logic-gated CAR T, in Participants With Solid Tumors That Express MSLN and Have Lost HLA-A*02 Expression
NCT06051695 · Solid Tumor, Adult,
Colorectal Cancer, NSCLC
RecruitingThe goal of this study is to test autologous logic-gated Tmod™ CAR T-cell products in subjects with solid tumors including colorectal cancer (CRC), pancreatic cancer (PANC), non-small cell lung cancer (NSCLC), ovarian cancer (OVCA), mesothelioma (MESO), and other solid tumors that express mesothelin (MSLN) and have lost HLA-A\*02 expression. The main questions this study aims to answer are: Phase 1: What is the recommended dose that is safe for patients Phase 2: Does the recommended dose kill solid tumor cells and protect the patient's healthy cells Participants will be required to perform study procedures and assessments, and will also receive the following study treatments: Enrollment and Apheresis in BASECAMP-1 (NCT04981119) Preconditioning Lymphodepletion (PCLD) Regimen Tmod CAR T cells at the assigned dose
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereGilbert, Arizona, United States + 11 more
SponsorA2 Biotherapeutics Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts PTM-101 in Pancreatic Ductal Adenocarcinoma (PDAC)
NCT06673017 · Pancreatic Ductal Adenocarcinoma, Borderline Resectable Pancreatic Adenocarcinoma, Locally Advanced Pancreatic Adenocarcinoma
RecruitingThis is a multi-center, non-randomized, single-arm, open-label, phase Ib, dose escalation/dose expansion study of PTM-101 when combined with neoadjuvant chemotherapy for the treatment of treatment-naïve subjects with borderline resectable and locally advanced pancreatic ductal adenocarcinoma (PDAC).
PhasePhase 1
TypeInterventional
Age18 Years
WhereNewport Beach, California, United States + 7 more
SponsorPanTher Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts