DBC-664 in Adult Patients With Solid Tumors
NCT07705035 · Malignant Germ Cell Tumor, Lung Adenocarcinoma, Gastric/Esophageal/Gastroesophageal Junction (GEJ) Adenocarcinoma
RecruitingDBC-664-ONC-101 is a first-in-human Phase 1a/1b open-label, multicenter study to evaluate the safety, tolerability, PK, pharmacodynamic, and preliminary anti-tumor activity of DBC-664 in patients with endometrial cancer, ovarian cancer, and other advanced solid tumors . This study is divided into 2 parts: Phase-1a Dose Escalation (Part 1), and Phase-1b Dose Expansion (Part 2). In each part, patients who meet specific eligibility criteria will be enrolled.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDenver, Colorado, United States + 4 more
SponsorDuboce Biopharmaceuticals, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of MGC026 in Participants With Advanced Solid Tumors
NCT06242470 · Advanced Solid Tumor, Advanced Cancer, Metastatic Cancer
RecruitingThe study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study. Participants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.
PhasePhase 1
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 11 more
SponsorMacroGenics
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors
RecruitingA Study of Emi-Le in Participants with Solid Tumors
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 25 more
SponsorDay One Biopharmaceuticals, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of PHST001 in Advanced Solid Tumors
NCT06840886 · Advanced Solid Tumors,
Ovarian Cancer, Endometrial Cancer
RecruitingThis is a multi-center, first-in-human (FIH), open-label, Phase 1a/1b dose escalation and dose expansion study to assess the safety, PK, pharmacodynamics, and antitumor activity of PHST001 monotherapy (Phase 1a) or in combination with chemotherapy (Phase 1b) in adult participants with advanced relapsed and/or refractory solid tumors (including but not limited to CNS tumors in Phase 1a only). In Phase 1b cohort expansions, the study will focus on participants with advanced relapsed and/or refractory ovarian cancer, endometrial cancer, and cholangiocarcinoma. The study's primary objective is to evaluate the safety and tolerability of PHST001 and determine the RP2D (Recommended Phase 2 dose) of PHST001 monotherapy and in combination with chemotherapy as well as assess the anti-tumor activity of PHST001 and chemotherapy in Phase 1b.
PhasePhase 1
TypeInterventional
Age18 Years
WhereBeverly Hills, California, United States + 19 more
SponsorPheast Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase 1 Study of PLN-101095 in Adults With Advanced or Metastatic Solid Tumors
NCT06270706 · Advanced or Metastatic Solid Tumor
RecruitingThis is a Phase 1a/1b, dose-escalation/expansion, consecutive-cohort, open-label study to evaluate the safety, tolerability, PK, PD, and preliminary evidence of antitumor activity of PLN-101095 in combination with pembrolizumab (the study treatment regimen) in adult participants with advanced or metastatic solid tumors for which pembrolizumab is indicated but have documented disease progression (refractory \[primary resistance\]) or relapsed \[secondary resistance\]) after at least 3 months from the start of treatment with pembrolizumab. The study will consist of 2 main parts: * Part 1: Consecutive dose-escalation cohorts using a Bayesian optimal interval (BOIN) dose escalation design with accelerated titration * Part 2: Dose-expansion cohorts using Simon's 2-stage design
PhasePhase 1
TypeInterventional
Age18 Years
WhereNew Haven, Connecticut, United States + 11 more
SponsorPliant Therapeutics, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Safety, PK and Efficacy of QXL138AM in Patients With Solid Tumors and Multiple Myeloma
NCT06582017 ·
Ovarian Cancer, Pancreas Cancer, Urothelial Carcinoma
RecruitingStudy QXL138AM-001 is a Phase 1a/1b study to investigate the safety, pharmacokinetics, and preliminary activity of QXL138AM in subjects with locally advanced un-resectable and/or metastatic solid tumors and multiple myeloma. The study is an open-label, multicenter, first in human study to be conducted in two major parts which are further organized into two sub-parts. Part A Dose Escalation is a modified 3+3 with the first two cohorts consisting of one subject each based on the low clinical starting dose. Dose escalation in solid tumors (Part A1) will be followed by dose finding in multiple myeloma (Part A2). Part B consists of dose expansion in solid tumors (Part B1) and multiple myeloma (Part B2) using the recommended dose for expansion from Part A
PhasePhase 1
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 9 more
SponsorNammi Therapeutics Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression Plus Endocrine Therapy in Premenopausal Patients With pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score Less Than or Equal to 25
NCT05879926 ·
Breast Cancer RecruitingThis Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).
PhasePhase 3
TypeInterventional
Age18 Years – 60 Years
WhereBirmingham, Alabama, United States + 1260 more
SponsorNRG Oncology
▾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
WhereDenver, Colorado, United States + 14 more
SponsorIDEAYA Biosciences
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Trial to Evaluate Ovarian Suppression Following Subcutaneous ZOLADEX 10.8 mg in Premenopausal Women With Early-stage and Advanced HR+ Breast Cancer
RecruitingThe primary objective of this trial is to evaluate ovarian suppression following treatment with ZOLADEX 10.8 mg by luteinizing hormone (LH) within each cohort.
PhasePhase 1
TypeInterventional
Age18 Years – 55 Years
WhereHot Springs, Arkansas, United States + 22 more
SponsorTerSera Therapeutics LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Sigvotatug Vedotin in Advanced Solid Tumors
NCT04389632 · Carcinoma, Non-Small Cell Lung, Squamous Cell Carcinoma of Head and Neck, HER2 Negative Breast Neoplasms
RecruitingThis trial will look at a drug called sigvotatug vedotin (SGN-B6A) alone and with pembrolizumab, with or without chemotherapy, to find out whether it is safe for people who have solid tumors. It will study sigvotatug vedotin to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study whether sigvotatug vedotin works to treat solid tumors. The study will have four parts. * Part A of the study will find out how much sigvotatug vedotin should be given to participants. * Part B will use the dose found in Part A to find out how safe sigvotatug vedotin is and if it works to treat solid tumors. * Part C of the study will find out how safe sigvotatug vedotin is in combination with these other drugs. * Part D will include people who have not received treatment. This part of the study will find out how safe sigvotatug vedotin is in combination with these other drugs and if these combinations work to treat solid tumors. * In Parts C and D, participants will receive sigvotatug vedotin with either: * Pembrolizumab or, * Pembrolizumab and carboplatin, or * Pembrolizumab and cisplatin.
PhasePhase 1
TypeInterventional
Age18 Years
WhereAnchorage, Alaska, United States + 157 more
SponsorSeagen, a wholly owned subsidiary of Pfizer
▾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 + 16 more
SponsorAstellas Pharma Global Development, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer With Cyclin E1 Overexpression
NCT07023627 ·
Ovarian Cancer RecruitingThis study will evaluate the safety and efficacy of INCB123667 in Participants With Platinum-Resistant Ovarian Cancer (PROC) With Cyclin E1 Overexpression.
PhasePhase 2
TypeInterventional
Age18 Years – 99 Years
WhereMobile, Alabama, United States + 73 more
SponsorIncyte Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts Serum Biomarkers to Characterize the Effects of Therapy on Ovarian Reserve in Premenopausal Women With Early-stage Breast Cancer or BRCA Mutations
NCT00823654 ·
Breast Cancer RecruitingThe purpose of this study is to learn more about the effects of your BRCA mutation on the ovaries. The BRCA gene can make it hard to conceive a child in the future. It may also bring on early menopause. The researchers will check blood levels of hormones that the ovaries produce. The hormones that researchers will check are anti-Mullerian hormone (AMH), estradiol and follicle stimulating hormone (FSH). The researchers will do this before, during, and after cancer treatment. The researchers will also ask you to fill out questionnaires about your menstrual cycle (your periods) and information about your health and pregnancies. This may help us learn which women will be more likely to have early menopause.
Phase—
TypeObservational
Age18 Years – 44 Years
WhereBasking Ridge, New Jersey, United States + 7 more
SponsorMemorial Sloan Kettering Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Testing Olaparib for One or Two Years, With or Without Bevacizumab, to Treat Ovarian Cancer
NCT06580314 · Fallopian Tube Endometrioid Adenocarcinoma, Fallopian Tube High Grade Serous Adenocarcinoma, Fallopian Tube Malignant Mixed Mesodermal (Mullerian) Tumor
RecruitingThis phase III trial compares the effect of olaparib for one year versus two years, with or without bevacizumab, for the treatment of BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer. Olaparib is a polyadenosine 5'-diphosphoribose polymerase (PARP) enzyme inhibitor and may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Giving olaparib for one year with or without bevacizumab may be effective in treating patients with BRCA 1/2 mutated or homologous recombination deficient stage III or IV ovarian cancer, when compared to two years of olaparib.
PhasePhase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 694 more
SponsorNRG Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors
NCT04657068 · Advanced Cancer, Metastatic Cancer,
Ovarian Cancer RecruitingThis clinical trial is evaluating a drug called ART0380 in participants with advanced or metastatic solid tumors. The main goals of this study are to: * Find the recommended dose of ART0380 that can be given safely to participants alone and in combination with gemcitabine or irinotecan * Learn more about the side effects of ART0380 alone and in combination with gemcitabine or irinotecan * Learn more about the effectiveness of ART0380 alone and in combination with gemcitabine or irinotecan
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 81 more
SponsorArtios Pharma Ltd
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400
NCT06084481 · Hepatocellular Carcinoma, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancers
RecruitingCancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors. ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called cohorts. Cohorts 1-8 receive ABBV-400 alone (monotherapy), cohort 9 receives ABBV-400 with a strong CYP3A3 inhibitor (ITZ), and cohort 10 receives ABBV-400 with bevacizumab. All cohorts are followed by a safety follow-up period. Approximately 325 adult participants with hepatocellular carcinoma (HCC), pancreatic ductal adenocarcinoma (PDAC), biliary tract cancers (BTC), esophageal squamous cell carcinoma (ESCC), triple negative breast cancer (TNBC), hormone receptor+/human epidermal growth factor receptor 2 negative (HER2-) breast cancer (hormone receptor-positive \[HR+\]/HER2-breast cancer \[BC\]), head and neck squamous-cell-carcinoma (HNSCC), Platinum Resistant High Grade Epithelial Ovarian Cancer (PROC)/primary peritoneal/fallopian tube cancer, or advanced solid tumors, will be enrolled in the study in approximately 54 sites worldwide. In cohorts 1-8, participants with the following advanced solid tumor indications: HCC, PDAC, BTC, ESCC, TNBC, HR+/HER2-BC, HNSCC, and PROC/primary peritoneal/fallopian tube cancer will receive intravenous (IV) ABBV-400 monotherapy, in cohort 9 participants will receive IV ABBV-400 and an oral solution of ITZ, and in cohort 10 participants will receive IV ABBV-400 and IV bevacizumab, for up to 3 years during and up to the treatment period with an additional safety follow-up period of up to 2 years. 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 53 more
SponsorAbbVie
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Sofe-M in Participants With Selected Advanced Solid Tumors
NCT06400472 · Ovarian Neoplasms, Endometrial Neoplasms, Uterine Cervical Neoplasms
RecruitingThe purpose of this study is to find out whether the study drug, Sofetabart Mipitecan (LY4170156), is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in three parts - phase Ia (dose-escalation, dose-optimization), phase Ib (dose-expansion), and phase 2 (dose expansion). The study will last up to approximately 5 years.
PhasePhase 1
TypeInterventional
Age18 Years
WhereScottsdale, Arizona, United States + 23 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts NYSCF Scientific Discovery Biobank
RecruitingThe New York Stem Cell Foundation (NYSCF) Research Institute is performing this research to accelerate diverse disease research using cells from the body (such as skin or blood cells) to make stem cells and other types of cells, conduct research on the samples, perform genetic testing, and store the samples for future use. Through this research, researchers hope to identify future treatments or even cures for the major diseases of our time.
Phase—
TypeObservational
Age30 Days
WhereNew York, New York, United States
SponsorNew York Stem Cell Foundation Research Institute
▾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 The Evaluation of PC14586 in Patients With Advanced Solid Tumors Harboring a TP53 Y220C Mutation (PYNNACLE)
NCT04585750 · Advanced Solid Tumor, Advanced Malignant Neoplasm, Metastatic Cancer
RecruitingThe Phase 2 monotherapy portion of this study is currently enrolling and will evaluate the efficacy and safety of PC14586 (INN rezatapopt) in participants with locally advanced or metastatic solid tumors harboring a TP53 Y220C mutation. The Phase 1 portion of the study will assess the safety, tolerability and preliminary efficacy of multiple dose levels of rezatapopt as monotherapy and in Phase 1b in combination with pembrolizumab.
PhasePhase 1 / Phase 2
TypeInterventional
Age12 Years
WhereIrvine, California, United States + 76 more
SponsorPMV Pharmaceuticals, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts