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 cfDNA Assay Prospective Observational Validation for Early Cancer Detection and Minimal Residual Disease
NCT05366881 · Brain Cancer,
Breast Cancer, Bladder Cancer
RecruitingThis is an observational case-control study to train and validate a genome-wide methylome enrichment platform to detect multiple cancer types and to differentiate amongst cancer types. The cancers included in this study are brain, breast, bladder, cervical, colorectal, endometrial, esophageal, gastric, head and neck, hepatobiliary, leukemia, lung, lymphoma, multiple myeloma, ovarian, pancreatic, prostate, renal, sarcoma, and thyroid. These cancers were selected based on their prevalence and mortality to maximize impact on clinical care. Additionally, the ability of the whole-genome methylome enrichment platform to detect minimal residual disease after completion of cancer treatment and to detect relapse prior to clinical presentation will be evaluated in lung cancer. This cancer was selected based on the existing clinical landscape and treatment availability.
Phase—
TypeObservational
Age40 Years
WhereDuarte, California, United States + 16 more
SponsorAdela, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts Tegavivint for the Treatment of Recurrent or Refractory Solid Tumors, Including Lymphomas and Desmoid Tumors
NCT04851119 · Colorectal Carcinoma, Endometrial Carcinoma,
Melanoma RecruitingThis phase I/II trial evaluates the highest safe dose, side effects, and possible benefits of tegavivint in treating patients with solid tumors that has come back (recurrent) or does not respond to treatment (refractory). Tegavivint interferes with the binding of beta-catenin to TBL1, which may help stop the growth of tumor cells by blocking the signals passed from one molecule to another inside a cell that tell a cell to grow.
PhasePhase 1 / Phase 2
TypeInterventional
Age12 Months – 30 Years
WhereBirmingham, Alabama, United States + 20 more
SponsorChildren's Oncology Group
▾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 FT836 With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors
RecruitingThis is a phase 1 study of FT836 administered in participants with advanced solid tumors. The primary objectives of the study are to evaluate the safety and tolerability of FT836 with or without paclitaxel and/or trastuzumab or cetuximab, and to determine the recommended phase 2 dose (RP2D) of FT836 in combination with trastuzumab or cetuximab; each objective will be assessed with or without paclitaxel chemotherapy.
PhasePhase 1
TypeInterventional
Age18 Years
WhereLa Jolla, California, United States + 4 more
SponsorFate Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts The goal of this study is to comprehensively measure ongoing concerns and unmet needs of individuals living with ovarian cancer. To accomplish this, the UNderstanding The experience of Ovarian cancer - Life after Diagnosis (UNTOLD) study will be conducted using a mixed-methods approach. Ovarian cancer survivors will be enrolled to participate in UNTOLD to complete a one-time survey regarding their experiences. Up to 40 survivors will be subsequently identified to complete a follow-up interview. To ensure these sample sizes, along with a representative sample, a combined recruitment strategy will be employed using the California Cancer Registry (population-based) and recruitment through ovarian cancer advocacy groups.
Phase—
TypeObservational
Age18 Years
WhereMinneapolis, Minnesota, United States
SponsorMasonic Cancer Center, University of Minnesota
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase 1 Study of NRM-823 in Participants With Locally Advanced or Metastatic Refractory Solid Tumors
NCT07182149 · HNSCC, ESCC, Esophageal Adenocarcinoma
RecruitingThis study is being done to find out of NRM-823 is safe and can treat participants with locally advanced or metastatic solid tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDenver, Colorado, United States + 8 more
SponsorNormunity AccelCo, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
NCT04251052 · Ovarian Carcinoma
RecruitingThis clinical trial evaluates how well two surgical procedures (bilateral salpingectomy and bilateral salpingo-oophorectomy) work in reducing the risk of ovarian cancer for individuals with BRCA1 mutations. Bilateral salpingectomy involves the surgical removal of fallopian tubes, and bilateral salpingo-oophorectomy involves the surgical removal of both the fallopian tubes and ovaries. This study may help doctors determine if the two surgical procedures are nearly the same for ovarian cancer risk reduction for women with BRCA1 mutations.
PhaseNA
TypeInterventional
Age35 Years – 50 Years
WhereBirmingham, Alabama, United States + 548 more
SponsorNRG Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of Carboplatin and Mirvetuximab Soravtansine in First-Line Treatment of Patients Receiving Neoadjuvant Chemotherapy With Advanced-Stage Ovarian, Fallopian Tube or Primary Peritoneal Cancer
NCT04606914 ·
Ovarian Cancer, Fallopian Tube, Primary Peritoneal Cancer
RecruitingThe proposed study design is a single arm Phase II trial to document the feasibility of carboplatin-mirvetuximab - in patients with advanced-stage EOC. Patients with biopsy confirmed, newly diagnosed, advanced-stage serous EOC deemed appropriate for NACT will have their tumors evaluated for FRα receptor over-expression via a centralized immunohistochemical assay (IHC) and identified as appropriate for study participation if IHC staining is PS2+ in \>75% of cells (40% of all serous patients). Eligible patients will receive NACT with one cycle of carboplatin, followed by mirvetuximab + carboplatin (if FRα +) every 21 days for three cycles prior to interval cytoreductive surgery (iCRS). A total of 70 will be included in the study. Following completion of 4 cycles total of NACT and after allowing for appropriate recovery of cycle # 4, patients eligible for surgery, will undergo an iCRS. Patients will then complete 3 more cycles of mirvetuximab + carboplatin for a total of 7 intended cycles of treatment. It is up to the treating physician if they want to add bevacizumab to the last 2 cycles or use any type of maintenance therapy. The decision to add bevacizumab or use maintenance therapy does not need to be made upfront. Patients will sign a screening consent form prior to tissue biopsy. If a patient is found to be FRα negative, their treating physician can select the treatment they deem appropriate and the patient will be declared a screen failure. Patients with BRCA mutations are not excluded from this trial and are allowed to receive standard of care maintenance therapy including bevacizumab and/or PARP inhibitors.
PhasePhase 2
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 8 more
SponsorUniversity of Alabama at Birmingham
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Safety and Efficacy of OPB-101 in Platinum-resistant Ovarian Cancer
RecruitingThe goal of this clinical trial is to learn if OPB-101 is safe in platinum resistant ovarian cancer participants and also to find the optimal dose of OPB-101. Participants will have their own T cells modified in a laboratory and given back to them as OPB-101 in this one-time treatment. Participants will be in the hospital when they receive OPB-101 and then be checked at the clinical site frequently for the first few months.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDetroit, Michigan, United States + 3 more
SponsorOutpace Bio, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Phase 1, Safety and Tolerability Study of XmAb541 in Advanced Solid Tumors
NCT06276491 ·
Ovarian Cancer, Endometrial Cancer, Germ Cell Tumor
RecruitingThe primary purpose of this study is to determine whether the investigational drug XmAb541 is safe and well tolerated, and to determine an optimal and safe dose(s) for further study. The study will also evaluate the effect of XmAb541 on tumor outcomes.
PhasePhase 1
TypeInterventional
Age15 Years
WhereDuarte, California, United States + 17 more
SponsorXencor, Inc.
▾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 CATALINA-2: A Clinical Study of TORL-1-23 in Platinum-resistant Ovarian Cancer.
NCT06690775 ·
Epithelial Ovarian Cancer, Primary Peritoneal, Fallopian Tube Cancer
RecruitingA Phase 2 study to evaluate the safety and efficacy of TORL-1-23 in patients with advanced ovarian cancer.
PhasePhase 2
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 65 more
SponsorTORL Biotherapeutics, LLC
▾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 + 1248 more
SponsorNRG Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts Relacorilant in Combination With Different Treatment Regimens in Patients With Gynecological Cancers
NCT06906341 ·
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Neoplasms
RecruitingThis is a Phase 2, open-label, global, multi-arm study to evaluate efficacy and safety of relacorilant in combination with other treatments in patients with gynecological cancers.
PhasePhase 2
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 48 more
SponsorCorcept Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Avutometinib (VS-6766) + Defactinib (VS-6063) in Recurrent Low-Grade Serous Ovarian Cancer
RecruitingThis study will assess the safety and efficacy of avutometinib (VS-6766) in combination with defactinib versus Investigator's choice of treatments (ICT) in subjects with recurrent LGSOC who have progressed on a prior platinum-based therapy.
PhasePhase 3
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 105 more
SponsorVerastem, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts AZD5335 vs. Mirvetuximab Soravtansine in FRα-high and AZD5335 vs. Chemotherapy in FRα-low Platinum-resistant Ovarian Cancer
RecruitingThe intention of the study is to demonstrate superiority of AZD5335 versus standard of care by assessment of progression-free survival (PFS) in women with high-grade, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, expressing high or low FRα levels.
PhasePhase 3
TypeInterventional
Age18 Years
WhereFort Lauderdale, Florida, United States + 124 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Assess Anti-Tumor Activity of Intravenously (IV) Infused Carboplatin With Mirvetuximab Soravtansine in Participants With Newly Diagnosed Folate Receptor Alpha (FRα)Expressing Advanced-Stage Serous Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer.
NCT06890338 ·
Epithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer
RecruitingCancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess the safety and efficacy of neoadjuvant carboplatin and mirvetuximab soravtansine in participants with folate receptor alpha (FRα) -expressing advanced-stage serous epithelial ovarian, fallopian tube or primary peritoneal cancer (EOC). Mirvetuximab Soravtansine (MIRV) is an investigational antibody drug conjugate designed to selectively kill cancer cells. The antibody (protein) part of MIRV targets tumors by delivering a cell-killing drug to cancer cells carrying a protein called folate receptor alpha (FRα). This is a single arm study in adult participants with advanced-stage Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) III-IV FRα-expressing serous EOC. Around 140 participants will be enrolled in the study at approximately 80 sites in the United States. Participants will receive intravenous infusion of MIRV in combination with carboplatin on day 1 of each cycle, every 21 days for up to 6 - 9 Cycles. The total study duration will be approximately 3 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 a hospital or clinic and may require frequent medical assessments, blood tests, and scans.
PhasePhase 2
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 65 more
SponsorAbbVie
▾Tap for detailsClick for full details — eligibility, all locations, contacts First in Human Study of TORL-1-23 in Participants With Advanced Cancer
NCT05103683 · Advanced Solid Tumor,
Ovarian Cancer, Endometrial Cancer
RecruitingThis first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-1-23 in patients with advanced cancer
PhasePhase 1
TypeInterventional
Age18 Years
WhereFullerton, California, United States + 13 more
SponsorTORL Biotherapeutics, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study to Assess Adverse Events and Pharmacokinetics in Adult Participants With Non-Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma and Other Solid Tumors, Receiving Intravenous Infusion of Azirkitug Alone or in Combination(s) With Budigalimab, Bevacizumab, or Telisotuzumab Adizutecan
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. Head and Neck Squamous Cell Carcinoma (HNSCC) is a solid tumor, a disease in which cancer cells form in the tissues of the head and neck. The purpose of this study is to assess adverse events and pharmacokinetics of azirkitug as a monotherapy and in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan. Bevacizumab is an approved product, while budigalimab, azirkitug, and telisotuzumab adizutecan are investigational drugs being developed for the treatment of NSCLC, HNSCC, and other solid tumors. Study doctors put the participants in groups called treatment arms. The maximum-tolerated dose (MTD)/maximum administered dose (MAD) of azirkitug will be explored. Each treatment arm receives a different dose of azirkitug in monotherapy and in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan. Approximately 694 adult participants will be enrolled in the study across approximately 80 sites worldwide. Participants will receive azirkitug as a monotherapy or in combination with budigalimab, bevacizumab, or telisotuzumab adizutecan as an Intravenous (IV) Infusion for an estimated treatment 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 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 1
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 47 more
SponsorAbbVie
▾Tap for detailsClick for full details — eligibility, all locations, contacts