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 Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
NCT05232916 · Breast Cancer
RecruitingThis is a prospective, randomized, double-blinded, placebo-controlled, multi-center, Phase 3 study of GLSI-100 immunotherapy in HLA-A\*02 positive and HER2/neu positive subjects who are at high risk for disease recurrence and have completed both neoadjuvant and postoperative adjuvant standard of care therapy. Treatment consists of 6 intradermal injections, Primary Immunization Series (PIS), over the first 6 months of treatment and 5 booster intradermal injections spaced 6 months apart. A third open-label arm will explore GLSI-100 immunotherapy in non-HLA-A\*02 positive and HER2/neu positive subjects.
PhasePhase 3
TypeInterventional
Age18 Years – 100 Years
WhereGoodyear, Arizona, United States + 165 more
SponsorGreenwich LifeSciences, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts CD40 Agonist, Flt3 Ligand, and Chemotherapy in HER2 Negative Breast Cancer
NCT05029999 · HER2-negative Breast Cancer, Metastatic Breast Cancer
RecruitingThis research study is being done to find out if the immunotherapy drugs called CDX-301 and CDX-1140 in combination with the standard chemotherapy treatment pegylated liposomal doxorubicin (PLD, Doxil) are safe and effective at controlling the cancer in patients with metastatic triple Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer, and to determine a safe dose and treatment schedule of the three drugs. This research study will also test how your immune system responds to these treatments alone and in combination.
PhasePhase 1
TypeInterventional
Age18 Years – 99 Years
WhereChicago, Illinois, United States + 6 more
SponsorUniversity of Texas Southwestern Medical Center
▾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 Study of Abemaciclib and Elacestrant in Participants With Brain Metastasis Due to ER+/HER-2- Breast Cancer
NCT05386108 · Breast Neoplasms, Brain Neoplasms, Neoplasms by Site
RecruitingThis is a multi-site, global, open-label study that includes a phase 1b evaluation of elacestrant in combination with abemaciclib in women and men with brain metastases from estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER-2) negative breast cancer. Phase 1b was designed to select the recommended phase 2 dose (RP2D) and is followed by an ongoing phase 2 evaluation of elacestrant in combination with abemaciclib in participants with active brain metastases from ER-positive, HER-2 negative breast cancer.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereFullerton, California, United States + 85 more
SponsorStemline Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
NCT07318805 · Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-), Colorectal Cancer
RecruitingThe purpose of this study is to learn about the safety and effects of the study medicine when given alone or together with other anti-cancer therapies. Anti-cancer therapy is a type of treatment to stop the growth of cancer. This study also aims to find the best amount of study medication. This study is seeking participants that have advanced or metastatic breast cancer (BC), or advanced or metastatic colorectal cancer (CRC). All participants in this study will take the study medication (PF-08032562) as pill by mouth. This will be repeated for 28-day cycles. Depending on which part of the study participants are enrolled into, they will receive the study medication PF-08032562 alone or in combination with other anti-cancer medications. The study medication (PF-08032562) will be taken by mouth (PO) in combination with other anti-cancer medications given in the study clinic by intramuscular (IM) injection into the muscle or intravenous (IV) infusion that is directly injected into the veins at different times (depending on the treatment) during the 28-day cycle. The study may also test different schedules.
PhasePhase 1
TypeInterventional
Age18 Years
WhereGrand Rapids, Michigan, United States + 2 more
SponsorPfizer
▾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 Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXd) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02)
NCT06330064 · Recurrent or Metastatic Solid Tumors
RecruitingThis study is designed to assess the efficacy and safety of ifinatamab deruxtecan (I-DXD) in the following tumor types: endometrial cancer (EC); head and neck squamous cell carcinoma (HNSCC); pancreatic ductal adenocarcinoma (PDAC); colorectal cancer (CRC); hepatocellular carcinoma (HCC); adenocarcinoma of esophagus, gastroesophageal junction, and stomach (Ad-Eso/GEJ/gastric); urothelial carcinoma (UC); ovarian cancer (OVC); cervical cancer (CC); biliary tract cancer (BTC); human epidermal growth factor 2 (HER2)-low breast cancer (BC); HER2 immunohistochemistry (IHC) 0 BC; and cutaneous melanoma.
PhasePhase 2
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 118 more
SponsorDaiichi Sankyo
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Sacituzumab Tirumotecan (MK-2870) as a Single Agent and in Combination With Pembrolizumab (MK-3475) Versus Treatment of Physician's Choice in Participants With HR+/HER2- Unresectable Locally Advanced or Metastatic Breast Cancer (MK-2870-010)
NCT06312176 · Breast Neoplasms
RecruitingThe purpose of this study is to compare sacituzumab tirumotecan as a single agent, and in combination with pembrolizumab, versus Treatment of Physician's Choice (TPC) in participants with hormone receptor positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) unresectable locally advanced, or metastatic, breast cancer. The primary hypotheses are that sacituzumab tirumotecan as a single agent and sacituzumab tirumotecan plus pembrolizumab are superior to TPC with respect to progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) by blinded independent central review (BICR) in all participants.
PhasePhase 3
TypeInterventional
Age18 Years
WhereChandler, Arizona, United States + 257 more
SponsorMerck Sharp & Dohme LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Invikafusp Alfa (STAR0602), a Selective T Cell Receptor (TCR)-Targeting, Bifunctional Antibody-fusion Molecule, in Combination With Sacituzumab Govitecan in Participants With Advanced Solid Tumors
NCT06827613 · Triple Negative Locally Advanced Non-resectable Breast Cancer, HR+, HER2-, Advanced Breast Cancer
RecruitingThis is a Phase 1b/2, Open-label Study to Investigate the Safety and Efficacy of Invikafusp alfa (STAR0602), a Selective T Cell Receptor (TCR)-targeting, Bifunctional Antibody-fusion Molecule, in Combination with Sacituzumab Govitecan in Participants with Unresectable, Locally Advanced, or Metastatic Solid Tumors.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 7 more
SponsorMarengo Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts First in Human Study of TUB-030 in Patients With Advanced Solid Tumors
NCT06657222 · Advanced Solid Tumors, HNSCC, SCLC
RecruitingThe goal of this clinical trial is to learn if the drug TUB-030 works to treat solid cancer in adults. The study will also explore the safety of TUB-030. The main questions it aims to answer are: To determine the safety and tolerability of TUB-030 To determine the maximum tolerated dose of TUB-030 as a single drug given to patients with solid cancer Researchers will also compare doses of TUB-030 in two specific cancer types, in patients with head and neck cancer and patients with non-small cell lung cancer, to see if TUB-030 works to treat these two solid cancer types and to determine the best dose. Participants will: Receive drug TUB-030 every 3 weeks Visit the clinic once every 3 weeks for checkups and tests Answer patient reported outcome questionnaires about their symptoms
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereNew Haven, Connecticut, United States + 15 more
SponsorTubulis GmbH
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4/6 Inhibitor and Letrozole vs Placebo + CDK4/6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer
NCT06790693 · Breast Cancer
RecruitingThis study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4/6i) and letrozole versus placebo plus a CDK4/6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).
PhasePhase 3
TypeInterventional
Age18 Years
WhereBurbank, California, United States + 218 more
SponsorHoffmann-La Roche
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
NCT07174336 · Breast Neoplasms, Neoplasm Metastasis
RecruitingThe purpose of the study is to assess the efficacy and safety of the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.
PhasePhase 3
TypeInterventional
Age18 Years
WhereAnchorage, Alaska, United States + 316 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts De-Escalation of Breast Radiation Trial for Hormone Sensitive, HER-2 Negative, Oncotype Recurrence Score Less Than or Equal to 18 Breast Cancer (DEBRA)
NCT04852887 · Stage I Breast Cancer
RecruitingThis Phase III Trial evaluates whether breast conservation surgery and endocrine therapy results in a non-inferior rate of invasive or non-invasive ipsilateral breast tumor recurrence (IBTR) compared to breast conservation with breast radiation and endocrine therapy.
PhasePhase 3
TypeInterventional
Age50 Years – 70 Years
WhereBirmingham, Alabama, United States + 831 more
SponsorNRG Oncology
▾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 SLV-154 Treatment of Metastatic Solid Tumors
NCT06771219 · Squamous Cell Cancer of Head and Neck (SCCHN), NSCLC, SCLC
RecruitingThis is a Phase 1 dose-escalation study evaluating the safety, pharmacokinetics, pharmacodynamics, immunogenicity, and efficacy of SLV-154 across a range of dose levels when administered to subjects with metastatic solid tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WhereNewport Beach, California, United States + 8 more
SponsorSolve Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study With NKT5097 for Adults With Advanced/Metastatic Solid Tumors
NCT07029399 · HR+ Breast Cancer, Triple Negative Breast Cancer (TNBC), CCNE1 Amplified Advanced Solid Tumors
RecruitingThe goal of this open-label dose escalation and expansion study is to evaluate the safety and tolerability of NKT5097 in adults with advanced/metastatic tumors (emphasis on breast cancer and solid tumors with CCNE1 amplification). Main questions to answer include: * What is the recommended dose for expansion and/or Phase 2 * What medical issues/symptoms do participants experience when taking NKT5097
PhasePhase 1
TypeInterventional
Age18 Years
WhereLa Jolla, California, United States + 13 more
SponsorNiKang Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Shortening Adjuvant Photon and Proton Irradiation (SAPPHIRe-II): A 4 Cohort, Randomized, Phase II Multi-center Trial Evaluating Shorter Schedules of Adjuvant Regional Nodal Irradiation Among Women and Men With Node-positive and High-risk Node-negative Invasive Breast Cancer
NCT07076485 · Breast Cancer
RecruitingTo learn about the effects of shorter RNI regimens in patients with breast cance who have had a lumpectomy or mastectomy and who are at higher risk for lower risk for the disease returning.
PhasePhase 2
TypeInterventional
Age18 Years
WhereVoorhees Township, New Jersey, United States + 2 more
SponsorM.D. Anderson Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts S1501 Dual Observational and Randomized Cohort Study of Patients With Metastatic HER-2+ Breast Cancer at Risk of Cardiac Toxicity
NCT03418961 · Cardiotoxicity, HER2/Neu Positive, Metastatic Malignant Neoplasm in the Brain
RecruitingThis trial has two cohorts of patients with human epidermal growth factor receptor (HER)-2-positive breast cancer that has spread to other places in the body. All patients must be receiving trastuzumab-based treatment. Both cohorts are being observed for cardiac toxicity. The largest cohort (currently open to accrual) is observational, and contains patients who are taking a beta blocker, ACE inhibitor, or ARB as well as their trastuzumab-based treatment. The goal is to understand how common cardiac problems are in this group of patients at high risk. The smaller cohort (currently closed to accrual) is randomized. Patients in this second cohort are randomized to either carvedilol or no treatment, with the goal of seeing whether carvedilol (used to treat heart failure and high blood pressure) may prevent the heart from side effects of chemotherapy.
PhasePhase 3
TypeInterventional
Age18 Years
WhereAnchorage, Alaska, United States + 589 more
SponsorSWOG Cancer Research Network
▾Tap for detailsClick for full details — eligibility, all locations, contacts