A Study of Mevrometostat for Treatment of Relapsed/Refractory SCLC, Castration Resistant Prostate Cancer, and Follicular Lymphoma
RecruitingThe purpose of this study is to learn about the safety and effects of the study medicine (called Mevrometostat) for the possible treatment of Relapsed/ Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) and Follicular Lymphoma (FL). The study consists of 3 parts; Part 1 and 2 enrolled participants with SCLC, metastatic CRPC, and FL are closed for enrollment. Part 3, which is open for enrollment is seeking men who: * have Castration Resistant Prostate Cancer (CRPC) and * have previously received treatment for CRPC and have progressed from the last treatment All participants in Part 3 of this study will receive mevrometostat and/ or enzalutamide. Part 3 consists of 2 sub studies each has an assessment phase and a maintenance phase. The Part 3 DDI substudy consist of 2 cohorts, Cohort 1 (monotherapy cohort) and Cohort 2 (Combination cohort). In the assessment phase: * participants in the BE substudy will take 3 single doses of mevrometostat by mouth over 3 periods. * participants in the DDI substudy Cohort 1 (monotherapy cohort) will take mevrometostat 2 times a day and/or itraconazole 1 time a day based on a present schedule. * participants in the DDI substudy Cohort 2 (combination cohort) will take mevrometostat 2 times a day, enzalutamide 1 time a day, and/or itraconazole 1 time a day based on a present schedule. After completion of the assessment phase, participants will enter the maintenance phase where they will receive mevrometostat 2 times a day and enzalutamide 1 time a day by mouth until their cancer is no longer responding. The study will look at the experiences of participanrs receiving the study medicine. This will help see if the study medicine is safe and effective.
PhasePhase 1
TypeInterventional
Age18 Years
WhereTucson, Arizona, United States + 82 more
SponsorPfizer
▾Tap for detailsClick for full details — eligibility, all locations, contacts SW-682 in Advanced Solid Tumors
NCT06251310 · Advanced Solid Tumor, Mesothelioma, Malignant
RecruitingThis is a first-in-human (FIH), Phase 1a/1b open-label, multicenter, dose escalation and dose expansion study of SW-682 in adult participants with metastatic or unresectable advanced solid tumors with or without Hippo pathway alterations that are refractory to, or have progressed, during or after appropriate prior systemic anticancer therapy, including chemotherapy, immunotherapy, radiation therapy or targeted therapy, or for which no treatment is available, or prior standard of care (SOC) therapy was not tolerated and for which there is no further SOC treatment available. The study includes a Part 1 (Phase 1a) dose escalation phase and a Part 2 (Phase 1b) dose expansion to optimize the dose to be used for further development. All participants will self-administer SW-682 by mouth in 28-day cycles.
PhasePhase 1
TypeInterventional
Age18 Years
WhereScottsdale, Arizona, United States + 7 more
SponsorSpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Assess Adverse Events and How Intravenously (IV) Infused Telisotuzumab Vedotin (ABBV-399) Moves Through the Body as a Monotherapy in Adult Participants With Previously Treated Non-Squamous Non-Small Cell Lung Cancer (NSCLC)
RecruitingCancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. Non-small cell lung cancer (NSCLC) is a solid tumor, a disease in which cancer cells form in the tissues of the lung. The purpose of this study is to assess how safe telisotuzumab vedotin is in adult participants with NSCLC. Change in disease activity and adverse events will be assessed. Telisotuzumab vedotin is an investigational drug being developed for the treatment of NSCLC. Participants will be randomly assigned a treatment of telisotuzumab vedotin in 1 of 3 arms at an 1:1:1 ratio. Each group receives intravenous (IV) infusion of telisotuzumab vedotin at different doses. Approximately 150 adult participants with c-Met overexpressing NSCLC will be enrolled in the study at approximately 80 to 90 sites worldwide. Participants will receive IV telisotuzumab vedotin at 1 of 3 dose regimens as part of a 3 year study duration. 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. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
PhasePhase 2
TypeInterventional
Age18 Years
WhereChandler, Arizona, United States + 77 more
SponsorAbbVie
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study to Evaluate the Safety, Tolerability & Efficacy of TNG462 in Combination in PDAC & NSCLC Patients
NCT06922591 · PDAC, PDAC - Pancreatic Ductal Adenocarcinoma, NSCLC
RecruitingTNG462-C102 is a Phase 1/2, open-label, multicenter study designed to determine the safety, tolerability, PK, PD, and preliminary antineoplastic activity of oral TNG462 in combination with RMC-6236, RMC-9805, mFOLFIRINOX or gemcitabine/nab-paclitaxel. The study comprises a dose escalation phase and a dose expansion phase.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereScottsdale, Arizona, United States + 17 more
SponsorTango Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts JAB-2485 Activity in Adult Patients With Advanced Solid Tumors
RecruitingThis study is to evaluate the safety and tolerability of JAB-2485 monotherapy in adult participants with advanced solid tumors.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereDetroit, Michigan, United States + 7 more
SponsorJacobio Pharmaceuticals Co., Ltd.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Cobimetinib in Refractory Langerhans Cell Histiocytosis (LCH), and Other Histiocytic Disorders
NCT04079179 · Langerhan's Cell Histiocytosis, Juvenile Xanthogranuloma, Erdheim-Chester Disease
RecruitingThis is a research study of a drug called cobimetinib in children and adults diagnosed with Langerhans cell histiocytosis (LCH), and other histiocytic disorders that has returned or does not respond to treatment. Cobimetinib blocks activation of a protein called Mitogen-activated protein kinase (MEK) that is part of incorrect growth signals in histiocytosis cells. Four different groups of patients will be enrolled.
PhasePhase 2
TypeInterventional
AgeAny
WherePhoenix, Arizona, United States + 11 more
SponsorCarl Allen
▾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 Evaluate the safety and tolerability of RMC-6236 in adults with specific RAS mutant advanced solid tumors.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereOrange, California, United States + 20 more
SponsorRevolution Medicines, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts This phase III trial compares standard therapy given after surgery (adjuvant) to standard therapy given before and after surgery (perioperative) in treating patients with stage II-IIIB non-small cell lung cancer (NSCLC) that can be removed by surgery (resectable). The usual approach for patients with resectable NSCLC is chemotherapy and/or immunotherapy before surgery, after surgery, or both before and after surgery. This study is being done to find out which approach is better at treating patients with lung cancer. Treatment will be administered according to the current standard of care at the time of enrollment. Chemotherapy options may include cisplatin, carboplatin, pemetrexed, gemcitabine, docetaxel, and vinorelbine at standard doses according to the treating physician. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of tumor cells. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Pemetrexed is in a class of medications called antifolate antineoplastic agents. It works by stopping cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill tumor cells. Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Other chemotherapy drugs, such as vinorelbine, 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 . Immunotherapy with monoclonal antibodies, such as nivolumab, pembrolizumab, and atezolizumab, may help the body's immune system attack the tumor, and may interfere with the ability of tumor cells to grow and spread. Starting treatment with chemotherapy and immunotherapy prior to surgery and continuing treatment after surgery may be a more effective treatment option than adjuvant therapy alone in patients with stage II-IIIB resectable NSCLC.
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 381 more
SponsorAlliance for Clinical Trials in Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts Symbiotic-Lung-20: A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Different Anticancer Agents in Advanced Cancers
RecruitingThis study is being done to learn more about a new medicine called PF-08634404 and how it works when used with other cancer medicines in people who have advanced solid tumors. An advanced solid tumor is a type of cancer that has spread beyond its original location and cannot be removed by surgery or cured with standard treatments. To join in the study, participants must: * Be 18 years or older * Participants with advanced non-small cell lung cancer (NSCLC), a type of lung cancer that has spread The study will look at: * Whether PF-08634404 is safe to use with other cancer medicines. * What side effects may happen. A side effect is anything the medicine does to your body that is not part of treating your disease. * Whether the combination of PF-08634404 and other cancer medicines can help treat solid tumors. The study has different parts, each testing PF-08634404 with a different cancer medicine: * Part A will test PF-08634404 with a medicine called sigvotatug vedotin. * Part B of the study will look at how well the new medicine PF-08634404 works when used together with another medicine. Participants will receive the study medicines through an intravenous (IV) infusion (injected into the vein) at the study clinic. All treatments will take place at clinical trial sites, where trained medical staff will monitor participants during and after each visit.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereFayetteville, Arkansas, United States + 54 more
SponsorPfizer
▾Tap for detailsClick for full details — eligibility, all locations, contacts FiH Study to Investigate Safety, PK and Efficacy of the NaPi2b ADC TUB-040 in Patients With PROC or r/r Adenocarcinoma NSCLC
RecruitingThe purpose of this multicentric, open label trial (NAPISTAR 1-01) is to evaluate the safety/tolerability, pharmacokinetics and preliminary efficacy of TUB-040 and to find the best dose of TUB-040 in patients with ovarian cancer and Non Small Cell Lung Cancer. TUB-040 is an antibody-drug-conjugate which delivers a topoisomerase I inhibitor to tumor cells which overexpress the target NaPi2b. The study consists of two parts: In dose escalation, ovarian cancer patients and lung cancer patients receive increasing doses of TUB-040 until the maximal tolerated dose is found. In dose optimization, at least two doses are compared with each other to determine which dose is optimal for patients. TUB-040 is given IV every 3 weeks until the disease progresses or the patient has to stop due to side effects.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 14 more
SponsorTubulis GmbH
▾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 Study With ABBV-CLS-484 in Participants With Locally Advanced or Metastatic Tumors
NCT04777994 · Advanced Solid Tumor Cancer
RecruitingThe study will assess the safety, PK, PD, and preliminary efficacy of ABBV-CLS-484 as monotherapy and in combination with a PD-1 targeting agent or with a or a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI). The trial aims to establish a safe, tolerable, and efficacious dose of ABBV-CLS-484 as monotherapy and in combination. The study will be conducted in three parts. Part 1 Monotherapy Dose Escalation, Part 2 Combination Dose Escalation and Part 3 Dose Expansion (Monotherapy and Combination therapy). Part 1, ABBV-CLS-484 will be administered alone in escalating dose levels to eligible subjects who have advanced solid tumors. Part 2, ABBV-CLS-484 will be administered at escalating dose levels in combination with a PD-1 targeting agent or with a VEGFR TKI to eligible subjects who have advanced solid tumors. Part 3, ABBV-CLS-484 will be administered alone as a monotherapy at the determined recommended dose in subjects with locally advanced or metastatic, relapsed or refractory head and neck squamous cell carcinoma (HNSCC), relapsed or refractory non-small cell lung cancer (NSCLC), and advanced clear cell renal cell carcinoma (ccRCC). ABBV-CLS-484 will also be administered at the determined recommended dose in combination with a PD-1 targeting or with a VEGFR TKI agent in subjects with locally advanced or metastatic, HNSCC, NSCLC, MSI-H tumors refractory to PD-1/PD-L1, and advanced ccRCC.
PhasePhase 1
TypeInterventional
Age18 Years
WhereTucson, Arizona, United States + 29 more
SponsorCalico Life Sciences LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts ONC-392 Versus Docetaxel in Metastatic NSCLC That Progressed on PD-1/PD-L1 Inhibitors
RecruitingThe goal of this Phase 3 clinical trial is to study the safety and efficacy of the nextgen anti-CTLA-4 antibody, gotistobart (ONC-392/BNT316), in patients with metastatic non-small cell lung cancer who have disease progressed on anti-PD-1/PD-L1 antibody based therapy. The study will test whether gotistobart, in comparison with chemotherapy agent docetaxel, could prolong the life for NSCLC patients. Patients will be randomized to be treated with either gotistobart or docetaxel, IV infusion, once every 21 days, for up to 17 cycles in approximately one year.
PhasePhase 3
TypeInterventional
Age18 Years
WhereDothan, Alabama, United States + 151 more
SponsorOncoC4, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (DLLEVATE)
RecruitingThe purpose of this study is to evaluate the efficacy and safety of ZL-1310 compared to Investigator's Choice Therapy in participants with relapsed Small Cell Lung Cancer.
PhasePhase 3
TypeInterventional
Age18 Years
WhereLa Jolla, California, United States + 75 more
SponsorZai Lab (Shanghai) Co., Ltd.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Multiparametric Image Analysis and Correlation With Outcomes in Lung Cancer Screening and Early Stage Lung Cancer
NCT03563976 ·
Lung Cancer RecruitingDetermine whether CT-based multiparametric analytical models may improve prediction of biopsy and treatment outcome in patients undergoing screening CT scan and/or treatment for early stage lung cancer
Phase—
TypeObservational
Age18 Years – 99 Years
WhereDallas, Texas, United States
SponsorUniversity of Texas Southwestern Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Clinical Study to Investigate the Efficacy and Safety of an Investigational Combination Therapy With BNT324 and BNT327 in Patients With Advanced Lung Cancer
RecruitingThis study aims to investigate the combination of BNT324, a B7-H3 antibody-drug conjugate (ADC) with BNT327, a programmed death-ligand 1 (PD-L1) and vascular endothelial growth factor (VEGF) bispecific antibody, in participants with advanced/metastatic or relapsed/progressive small cell lung cancer (SCLC) and non small cell lung cancer (NSCLC).
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 87 more
SponsorBioNTech SE
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of XB010 in Subjects With Solid Tumors
NCT06545331 · Locally Advanced or Metastatic Solid Tumors, Esophageal Squamous Cell Cancer, Head and Neck Squamous Cell Cancer
RecruitingThis is a FIH study is to evaluate the safety, tolerability, PK, immunogenicity, and preliminary antitumor activity of XB010 as a single agent and in combination with pembrolizumab in subjects with locally advanced or metastatic solid tumors for whom alternative therapies do not exist or available therapies are intolerable or no longer effective.
PhasePhase 1
TypeInterventional
Age18 Years
WhereIrvine, California, United States + 19 more
SponsorExelixis
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of RAS(ON) Inhibitors in Patients With Advanced RAS-mutated NSCLC
RecruitingThe purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors as a monotherapy or combined with Standard(s) of Care (SOC) or with each other. The first four subprotocols include the following: Subprotocol A: RMC-6291 +/- RMC-6236 + SOC Subprotocol B: RMC-6236 + SOC Subprotocol C: RMC-9805 +/- RMC-6236 + SOC Subprotocol D: RMC-9805
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereGilbert, Arizona, United States + 92 more
SponsorRevolution Medicines, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adult Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
RecruitingThis study is being done to find out if a new medicine called PF-08634404, when given with chemotherapy, works better than the present standard treatment (pembrolizumab with chemotherapy) for adults with a type of lung cancer called non-small cell lung cancer (NSCLC) that is either locally advanced (spread to nearby tissues) or has spread to other parts of the body. To join the study, participants must meet the following conditions: * Be 18 years or older. * Have locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC. * Is not a candidate for complete surgical resection or curative chemoradiotherapy. * Do not have known actionable genomic alterations * Be treatment naïve for advanced or metastatic disease Participants in this study will be assigned to two different parts of the study depending on their type of tumor: participants with squamous NSCLC will be assigned to Part 1, while participants with non-squamous NSCLC will be assigned to Part 2. Each participant will be randomly assigned (like a flip of the coin) to one of two treatment groups in a blinded fashion: * Part 1 - Arm A or Part 2 - Arm C (Experimental Group): Will receive a new study medicine called PF-08634404 along with a kind of chemotherapy specific to the type of tumor. * Part 1 - Arm B or Part 2 - Arm D (Control Group): Will receive an approved medicine called pembrolizumab along with a kind of chemotherapy specific to the type of tumor. Participants will receive their assigned treatment through intravenous (IV) infusions, which means the medicine is given directly into a vein. The treatment will be given in cycles, participants will receive PF-08634404 or Pembrolizumab in combination with chemotherapy followed by maintenance with either PF-08634404 or Pembrolizumab monotherapy (Part 1) or PF-08634404 or Pembrolizumab in combination with a chemotherapeutic drug (Part 2). Participants will continue receiving treatment if it is helping and not experiencing serious side effects. The study will include regular visits for: * Treatment and health checks: while participant continues receiving treatment. * Tests to monitor how cancer responds: every 6 weeks during the first 48 weeks, then every 12 weeks thereafter.
PhasePhase 3
TypeInterventional
Age18 Years
WhereBullhead City, Arizona, United States + 372 more
SponsorPfizer
▾Tap for detailsClick for full details — eligibility, all locations, contacts