Phase 1 Study of OP-3136 in Advanced or Metastatic Solid Tumors
NCT06784193 · Advanced or Metastatic ER+ HER2- Breast Cancer (mBC), Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC), Advanced or Metastatic Castration-Resistant Prostate Cancer (mCRPC)
RecruitingThis is a first-in-human, open-label, multicenter phase 1 study to evaluate safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary efficacy of OP-3136, a lysine acetyltransferases 6A and 6B (KAT6A/B) inhibitor, as monotherapy and in combination with other anticancer agents in participants with advanced solid tumors. This study consists of 2 parts: a dose escalation part (Part 1) and dose expansion part (Part 2).
PhasePhase 1
TypeInterventional
Age18 Years
WhereSarasota, Florida, United States + 7 more
SponsorOlema Pharmaceuticals, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of RMC-5127 in Patients With Advanced KRAS G12V-Mutant Solid Tumors
NCT07349537 · Non-small Cell Lung Cancer (NSCLC), Colorectal Cancer (CRC), Pancreatic Adenocarcinoma
RecruitingThe purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of RMC-5127 as a monotherapy and in combination with either daraxonrasib or cetuximab in adults with KRAS G12V-mutant solid tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WhereGrand Rapids, Michigan, United States + 4 more
SponsorRevolution Medicines, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of WEF-001 as Monotherapy in Advanced KRAS-Mutant Solid Tumours.
NCT07148128 · Advanced or Metastatic KRAS-mutant Tumor in Pancreatic Adenocarcinoma, Advanced or Metastatic KRAS-mutant Tumor in Colorectal Cancer, Advanced or Metastatic KRAS-mutant Tumor in Non Small Cell Lung Cancer
RecruitingThis is a study designed to assess the safety, tolerability, pharmacokinetics and preliminary efficacy of WEF-001 as monotherapy in patients with Advanced KRAS-mutant solid tumours.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereDallas, Texas, United States + 3 more
SponsorAuricula Biosciences Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of ZW251 in Participants With Advanced Solid Tumors
NCT07164313 · Hepatocellular Carcinoma, Squamous Cell Non-Small Cell Lung Cancer, Germ Cell Tumor
RecruitingThe purpose of this study is to find out if ZW251, an antibody-drug conjugate targeting glypican-3 (GPC3), is safe and can treat participants with advanced cancers, including hepatocellular carcinoma (HCC), squamous cell non-small cell lung cancer (NSCLC), or germ cell tumors (GCT).
PhasePhase 1
TypeInterventional
Age18 Years
WhereSan Francisco, California, United States + 22 more
SponsorZymeworks BC Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate Pumitamig Versus Durvalumab Following Concurrent Chemoradiation Therapy in Participants With Unresectable Stage III Non-small Cell Lung Cancer (NSCLC) (ROSETTA Lung-201)
NCT07361497 · Non-small Cell Lung Cancer (NSCLC)
RecruitingA study to evaluate Pumitamig versus Durvalumab following concurrent chemoradiation therapy in participants with unresectable stage III Non-small Cell Lung Cancer (NSCLC)
PhasePhase 3
TypeInterventional
Age18 Years
WhereDaphne, Alabama, United States + 254 more
SponsorBristol-Myers Squibb
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of IDE034 in Adult Participants With Locally Advanced/Metastatic Solid Tumors Types
NCT07503808 · Esophageal Squamous Cell Carcinoma, High Grade Serous Ovarian Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingThis is a Phase 1a/1b, open-label, multicenter dose escalation and dose expansion clinical study to evaluate the safety, PK, immunogenicity and preliminary efficacy of IDE034 in participants with locally advanced/metastatic solid tumor types that express B7-H3 and PTK7.
PhasePhase 1
TypeInterventional
Age18 Years
WhereAustin, Texas, United States + 4 more
SponsorIDEAYA Biosciences
▾Tap for detailsClick for full details — eligibility, all locations, contacts Phase 1/2 Dose Finding, Safety and PK Study in Advanced Refractory Solid Tumors
NCT07145255 · Prostate Cancer Castration-resistant Prostate Cancer, Breast Cancer, Colo-rectal Cancer
RecruitingThis is a multicenter, open-label FIH, Phase 1a (dose escalation), Phase 1b (dose expansion) and Phase 2 study in patients with advanced metastatic solid tumors refractory to standard treatment.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereSan Francisco, California, United States + 6 more
SponsorMBrace 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 Thoracotomy Versus Thoracoscopic Management of Pulmonary Metastases in Patients With Osteosarcoma
NCT05235165 · Metastatic Malignant Neoplasm in the Lung, Metastatic Osteosarcoma, Osteosarcoma
RecruitingThis phase III trial compares the effect of open thoracic surgery (thoracotomy) to thoracoscopic surgery (video-assisted thoracoscopic surgery or VATS) in treating patients with osteosarcoma that has spread to the lung (pulmonary metastases). Open thoracic surgery is a type of surgery done through a single larger incision (like a large cut) that goes between the ribs, opens up the chest, and removes the cancer. Thoracoscopy is a type of chest surgery where the doctor makes several small incisions and uses a small camera to help with removing the cancer. This trial is being done evaluate the two different surgery methods for patients with osteosarcoma that has spread to the lung to find out which is better.
PhasePhase 3
TypeInterventional
Age50 Years
WhereBirmingham, Alabama, United States + 231 more
SponsorChildren's Oncology Group
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of Sacituzumab Govitecan Versus Standard of Care in Participants With Previously Treated Extensive Stage Small Cell Lung Cancer
NCT06801834 · Extensive Stage Small Cell Lung Cancer (ES-SCLC)
RecruitingThe goal of this clinical study is to learn more about the study drug sacituzumab govitecan (SG; Trodelvy®; GS-0132; IMMU 132), versus standard of care (SOC) in participants with previously treated extensive stage small cell lung cancer (ES-SCLC). The primary objectives of this study are to compare the effect of SG to SOC on objective response rate (ORR) as assessed by blinded independent central review (BICR) according to the Response Evaluation Criteria in Solid Tumors and to compare the effect of SG to SOC on overall survival (OS).
PhasePhase 3
TypeInterventional
Age18 Years
WhereAnaheim, California, United States + 204 more
SponsorGilead Sciences
▾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
NCT05671510 · Non Small Cell Lung Cancer
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 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 First-in-human Study to Learn How Safe BAY 3713372 is and How it Works in Participants With MTAP-deleted Solid Tumors
NCT06914128 · MTAP-deleted Solid Tumors
RecruitingThe study treatment, BAY 3713372, is under development to treat MTAP (methylthioadenosine phosphorylase)-deleted solid tumors. It is thought to work by blocking the protein arginine N-methyltransferase 5 (PRMT5). This may kill the MTAP-deleted cancer cells while sparing the normal cells. The main objective of this first-in-human study is to learn how safe BAY 3713372 is, how the body processes it, and how well it works in people with MTAP-deleted solid tumors. For this, the researchers will study and analyze: * the number of participants who have adverse events (AEs) after receiving different doses of BAY 3713372 and the AE's severity. * the number of participants who experience dose-limiting toxicities (DLTs) after receiving different doses of BAY 3713372, the DLT's severity and how often they happened. A DLT is a pre-defined medical problem caused by a specific dose of a drug that is too severe to continue using that dose. * the total amount of BAY 3713372 in participants' blood (also called AUC) over time after single and multiple doses. * the highest level of BAY 3713372 in participants' blood (also called Cmax) after single and multiple doses. Other than the main objective, researchers will also check for the number of participants who show a response to treatment and how long they live without the cancer getting worse. The study participants will take part in one of the seven distinct groups or "intervention cohorts" of the study. The study will start with a dose escalation phase where distinct groups of participants will receive different doses of BAY 3713372 alone to find the dose that is deemed safe and works best for the participants. When this dose has been found, a larger number of participants will receive BAY 3713372 alone or with other treatments in a dose expansion phase. Participants may take the study treatment as long as they benefit from the treatment without any severe medical problems. Participants will visit the study site: * at least twice before the treatment starts * multiple times when they start taking the treatment * once after 30 days of receiving the last dose and every 9 weeks after that until the cancer worsens, or the participant stops for any other reason During the study, the doctors and their study team will: * check participants' health by performing tests such as blood and urine tests, and checking heart health using an electrocardiogram * check if the participants' cancer has grown and/or spread using computed tomography (CT) or magnetic resonance imaging (MRI) and, if needed, bone scan * take tumor samples The study doctors and their team will contact the participants every 3 months until 2 years after the last participant's last dose or the end of the study to learn about the participant's health.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 59 more
SponsorBayer
▾Tap for detailsClick for full details — eligibility, all locations, contacts Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]
NCT06422143 · Non-small Cell Lung Cancer, NSCLC
RecruitingThis is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).
PhasePhase 3
TypeInterventional
Age18 Years
WhereLittle Rock, Arkansas, United States + 204 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Patient-derived Organoid Model and Circulating Tumor Cells for Treatment Response of Lung Cancer
NCT03655015 · Lung Neoplasm
RecruitingCreate a living biobank of PDOs from Stage I-III lung cancer patients.
Phase—
TypeObservational
Age18 Years
WhereSan Antonio, Texas, United States
SponsorThe University of Texas Health Science Center at San Antonio
▾Tap for detailsClick for full details — eligibility, all locations, contacts Clinical Study of Ivonescimab for First-line Treatment of Metastatic NSCLC Patients
NCT05899608 · Non-Small Cell Lung Cancer
RecruitingThis is a Phase 3 Randomized, double-blind, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer. The primary endpoint is overall survival and progression free survival assessed by investigator. The key secondary endpoints include response and safety.
PhasePhase 3
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 243 more
SponsorSummit Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase 1 Study of LNCB74 in Advanced Solid Tumors
NCT06774963 · Ovarian Cancer, Breast Cancer, Endometrial Cancer
RecruitingThis is an open-label, phase 1, dose escalation and dose expansion study to determine safety and tolerability, and to determine the maximum tolerated dose and / or recommended phase 2 dose of LNCB74 in participants with advanced solid tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WhereNewport Beach, California, United States + 13 more
SponsorNextCure, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of PT0511 in Participants With KRAS Mutated or Amplified Advanced Solid Tumors
NCT07300150 · Colorectal Cancer, Pancreatic Cancer, Non-Small Cell Lung Cancer
RecruitingThe primary purpose of this study is to evaluate the safety and tolerability, determine the maximally tolerated dose (MTD) and/or recommended Phase 2 dose(s) (RP2D) of PT0511 in adult participants with solid tumors as monotherapy and in combination with cetuximab in participants with colorectal cancer (CRC).
PhasePhase 1
TypeInterventional
Age18 Years
WhereBoston, Massachusetts, United States + 4 more
SponsorPAQ Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Amivantamab in Combination With Lazertinib, or Amivantamab in Combination With Platinum-Based Chemotherapy, for Common Epidermal Growth Factor Receptor (EGFR)-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
NCT06667076 · Carcinoma, Non-Small-Cell Lung
RecruitingThe primary purpose of the study is to assess how well amivantamab in combination with lazertinib or in combination with chemotherapy works (antitumor activity) in participants with epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC; that is one of the major types of lung cancer).
PhasePhase 2
TypeInterventional
Age18 Years
WhereDaphne, Alabama, United States + 195 more
SponsorJanssen Research & Development, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Phase I Study of SYS6043 in Patients With Advanced/Metastatic Solid Tumors
NCT07424547 · Cancer, Solid Tumor Cancer, Advanced Metastatic Cancer
RecruitingThe goal of this clinical trial is to learn if investigational drug called SYS6043 works in adults with advanced or metastatic solid tumors that have spread or cannot be treated with standard therapies. The main goals of the study are to understand how safe SYS6043 is, what side effects it may cause, and what dose can be given safely. Researchers will also study how the drug moves through the body and whether the immune system reacts to it. In addition, the study will look for early signs that SYS6043 may help slow or shrink tumors and explore whether the amount of a tumor protein called B7-H3 is related to how well the treatment works. Participants will: * Provide written informed consent * Undergo screening tests to ensure they are eligible for study treatment * Attend all required study visits and receive SYS6043 by intravenous infusion once every 3 weeks (Q3W), with 21 days as one treatment cycle until the study doctor determines that study treatment should be stopped based on how well a participant is doing on treatment. * Have safety follow-up (SFU), and long-term follow-up. * Be followed until progression.
PhasePhase 1
TypeInterventional
Age18 Years
WherePlantation, Florida, United States + 4 more
SponsorConjupro Biotherapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts