A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of INV-8989 in Patients With Advanced Solid Tumors Harboring KRAS G12D Mutations
NCT07610798 · Advance Solid Tumors, Colon and Rectal Cancer,
Non - Small Cell Lung Cancer NSCLC RecruitingThis is a Phase 1 and Phase 2 study to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of INV-8989 in patients with advanced solid tumors harboring KRAS G12D mutations.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereGuangzhou, Guangdong, China
SponsorShenzhen Ionova Life Sciences Co., Ltd.
▾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 Utility of Adjusting Chemotherapy Dose & Dosing Schedule With the SALVage Weekly Dose-dense Regimen in Patients With Poor Prognostic OVARian Cancers Based on the Tumor Unfavorable Primary Chemosensitivity and Incomplete Debulking Surgery
NCT06476184 ·
Ovarian Cancer RecruitingSALVOVAR will be a pragmatic open-label multicenter randomized phase III trial (ratio 1:1) comparing the efficacy of the salvage weekly dose-dense regimen with those of the continuation of the standard regimen.
PhasePhase 3
TypeInterventional
Age18 Years
WhereAngers, France + 75 more
SponsorARCAGY/ GINECO GROUP
▾Tap for detailsClick for full details — eligibility, all locations, contacts Leuprolide and Goserelin for Ovarian Function Suppression in Pre- or Peri-menopausal Women With Breast Cancer, OFS Trial
RecruitingThis phase II trial compares leuprolide to goserelin for reducing estrogen production by the ovaries in pre- or peri-menopausal women with breast cancer. Estrogen can cause the growth of breast cancer cells. Both leuprolide and goserelin lower the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. This study compares lower dose leuprolide, higher dose leuprolide, and goserelin for their ability to suppress the function of the ovaries to produce estrogen. Both doses of leuprolide may be as safe, tolerable and/or effective as goserelin in suppressing ovarian function in pre- or peri-menopausal women with breast cancer.
PhasePhase 2
TypeInterventional
Age18 Years
WhereAnn Arbor, Michigan, United States
SponsorUniversity of Michigan Rogel Cancer Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of NT-175 in Adult Participants With Advanced Malignancies That Are Positive for HLA-A*02:01 and the TP53 R175H Mutation
NCT05877599 ·
Non-small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Carcinoma
RecruitingPhase I Study of NT-175, an autologous T cell therapy product genetically engineered to express an HLA-A\*02:01-restricted T cell receptor (TCR), targeting TP53 R175H mutant malignancies
PhasePhase 1
TypeInterventional
Age18 Years
WhereGilbert, Arizona, United States + 22 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts Investigating Idetrexed and Olaparib in Patients With Ovarian Cancer
RecruitingTwo drugs called Idetrexed and olaparib are being evaluated. Idetrexed is a type of drug called an "aFR-targeted thymidylate synthase inhibitor". Idetrexed has been designed to selectively target cancer cells that have a protein called folate receptor on the surface of cancer cells. Thymidylate synthase is key to cancer cells for creating new DNA when they multiply. Blocking the action of thymidylate synthase with a drug like Idetrexed may therefore stop cancers from growing by damaging DNA in cancer cells. Olaparib is a type of drug called a "PARP inhibitor". It prevents cells repairing DNA damage. This leads to cells dying. Combining Idetrexed and olaparib should increase the number of cancer cells dying, especially those cells that have a lot of folate receptors. Cancer cells with a high number of folate receptors should be targeted more than normal healthy cells.
PhasePhase 1
TypeInterventional
Age18 Years
WhereCambridge, Cambridgeshire, United Kingdom + 2 more
SponsorInstitute of Cancer Research, United Kingdom
▾Tap for detailsClick for full details — eligibility, all locations, contacts Phase 1, Safety and Tolerability Study of XmAb541 and XmAb808 in Advanced Solid Tumors
NCT07593092 ·
Ovarian Cancer RecruitingThe primary purpose of this study is to determine whether the combination of the investigational drug XmAb541 in combination with the investigational drug XmAb808 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 in combination with XmAb808 on participants' tumor outcomes.
PhasePhase 1
TypeInterventional
Age18 Years
WhereLake Success, New York, United States + 3 more
SponsorXencor, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Dose Determining Study of EXS74539 (REC-4539) in Participants With Select Solid Tumors
NCT07517198 · Solid Tumor,
Small Cell Lung Cancer (SCLC), High Grade Neuroendocrine Cancer
RecruitingThe primary purpose of this study is to determine the safety, tolerability, and maximum tolerated dose (MTD) of EXS74539 (REC-4539) in participants with select solid tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 2 more
SponsorExscientia AI Ltd., a wholly owned subsidiary of Recursion Pharmaceuticals, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Acute Progesterone Suppression of Wake vs. Sleep Luteinizing Hormone Pulse Frequency in Pubertal Girls With and Without Hyperandrogenism
NCT00929006 · Puberty, Hyperandrogenism
RecruitingThe purpose of this study is two-fold. (1) We will determine if in mid- to late pubertal girls without hyperandrogenism (HA), progesterone (P4) acutely reduces waking luteinizing hormone (LH) frequency to a greater extent than sleep-associated LH frequency. (2) We will determine if in mid- to late pubertal girls with HA, P4 will acutely suppress waking LH frequency to a lesser degree than it does in girls without HA.
PhaseEARLY_Phase 1
TypeInterventional
Age10 Years – 17 Years
WhereCharlottesville, Virginia, United States
SponsorUniversity of Virginia
▾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 A Study of SHR-A1811 in Subjects With Ovarian Cancer
NCT06828354 ·
Ovarian Cancer RecruitingThis is an open-label study to evaluate the safety and efficacy of SHR-A1811 for injection in subjects with ovarian cancer.
PhasePhase 3
TypeInterventional
Age18 Years – 75 Years
WhereWuhan, Hubei, China + 1 more
SponsorJiangsu HengRui Medicine Co., Ltd.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase 2, Open-label, Single-arm Study Of Autologous M-CENK Adoptive Cell Therapy And N-803 (IL-15 Superagonist) In Combination With Gemcitabine In Participants With Recurrent Platinum-Resistant High-Grade Ovarian Cancer
RecruitingThis is phase 2 single arm study evaluating the safety and preliminary efficacy of M-CENK adoptive cell therapy and fixed dose of N-803 in combination with gemcitabine in participants with platinum-resistant high-grade ovarian cancer (HGOC).Up to 20 participants will receive M-CENK (IV) and N-803 (SC) in combination with gemcitabine (IV). Participants will undergo an apheresis procedure for the collection of mononuclear cells (MNCs) at least 1 day prior to Cycle 1 for manufacturing of M-CENK. Starting in Cycle 1, participants will receive gemcitabine and starting in Cycle 2 they will also receive M-CENK and N-803, until no additional M-CENK is available or confirmed PD per iRECIST, unless the participant is potentially deriving benefit per Investigator's assessment. Participants who complete the study treatment or discontinue study treatment will be followed for survival/disease status every 12 weeks (± 2 weeks) for up to 12 months after the last study treatment or until death, lost to follow-up, or withdrawal of consent.
PhasePhase 2
TypeInterventional
Age18 Years – 85 Years
WhereEl Segundo, California, United States + 1 more
SponsorImmunityBio, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
NCT05932862 · Advanced Solid Tumor
RecruitingThis is a first-in-human (FIH), multicenter, open-label Phase I study to investigate the safety, tolerability, preliminary antitumor activity, as well as pharmacokinetics (PK) and pharmacodynamics of XL309 (previously ISM3091) administered alone or in combination with olaparib in participants with advanced solid tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WhereFountain Valley, California, United States + 15 more
SponsorExelixis
▾Tap for detailsClick for full details — eligibility, all locations, contacts Rinatabart Sesutecan (Rina-S, PRO1184, GEN1184) for Advanced Solid Tumors (GCT1184-01/ PRO1184-001)
RecruitingThis study will test the safety, including side effects, and determine the characteristics of a drug called Rina-S in participants with solid tumors. Participants will have solid tumor cancer that has spread through the body (metastatic) or cannot be removed with surgery (unresectable).
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WherePhoenix, Arizona, United States + 65 more
SponsorGenmab
▾Tap for detailsClick for full details — eligibility, all locations, contacts A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors
RecruitingThis study is designed to evaluate AZD8421 alone and in combination with selected targeted anti-cancer drugs in patients with ER+HER2- advanced breast cancer, and patients with metastatic high-grade serious ovarian cancer.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereSt Louis, Missouri, United States + 13 more
SponsorAstraZeneca
▾Tap for detailsClick for full details — eligibility, all locations, contacts Efficay of Physical Activity Program in PCOS Females With Fatty Pancrease and Thyroid Hypofunction
NCT07591246 · Polycystic Ovary Syndrome, Non-Alcoholic Fatty Pancreatic Disease, Subclinical hypothyroïdism
Recruitingfemales of polycystic ovary syndromes may complain fatty pancreaetic disorder and thyroid hypofunctions (subclinical hypothyroidism)
PhaseNA
TypeInterventional
Age20 Years – 40 Years
WhereGiza, Egypt
SponsorCairo University
▾Tap for detailsClick for full details — eligibility, all locations, contacts This is a Phase 1 Trial of ZM008, an Anti-LLT1 Antibody, Used as Single Agent Followed by Combination Treatment With Toripalimab in Patients With Advanced Solid Tumors
NCT06451497 ·
Non Small Cell Lung Cancer, Head and Neck Squamous Cell Carcinoma, Pancreas Adenocarcinoma
RecruitingThis is a phase 1 dose escalation trial of ZM008, an anti-LLT1 antibody as a single agent followed by combination with Toripalimab in patients with advanced solid tumors who have exhausted all standard therapy available or are intolerant of the same.
PhasePhase 1
TypeInterventional
Age18 Years
WhereBoston, Massachusetts, United States + 2 more
SponsorZumutor Biologics Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Utero-ovarian Transposition in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy
NCT07419490 · Colorectal (Colon or Rectal) Cancer, Pelvic Malignancies, Oncofertility
RecruitingThis study is designed as a Phase I clinical trial enrolling female patients aged 18-40 years who have been diagnosed with pelvic malignancies requiring whole pelvic external radiation therapy (WPXRT) and who express interest in preserving fertility and ovarian function. The trial's primary objective is to assess the feasibility and safety of uterine and ovarian transposition (UOT). Premenopausal women under the age of 40 will undergo UOT using a novel minimally invasive approach. Feasibility and safety will be evaluated through standardized postoperative assessments, including: (A) success in mobilizing and repositioning the uterus, ovaries, and fallopian tubes while maintaining vascular integrity; (B) documentation of surgical complications; (C) monitoring the timeliness and adherence to planned WPXRT. To enhance safety and optimize outcomes, intraoperative imaging with indocyanine green fluorescence and Doppler ultrasonography will be employed. Short-term success will be defined by technical success in repositioning the uterus and ovaries with preserved vascular integrity, absence of major surgical complications, and timely initiation and completion of WPXRT. Long-term success will be evaluated by the preservation of fertility. The study's primary objective is also to evaluate surgical, reproductive, and quality-of-life outcomes following UOT. This objective will determine the procedure's efficacy in preserving ovarian and menstrual function and its potential to support future pregnancies. Endpoints include: (A) maintenance of normal premenopausal levels of FSH, LH, AMH, and estradiol at defined postoperative intervals; (B) assessment of menstrual timing, regularity, and characteristics to document return of ovulatory cycles; (C) evaluation of uterine integrity and reproductive potential using pelvic ultrasonography; (D) comprehensive evaluation of patient quality of life encompassing physical, emotional, sexual, and reproductive well-being. These measures will inform optimization of surgical techniques and provide a foundation for scaling the procedure to a broader population in future studies.
PhaseNA
TypeInterventional
Age18 Months – 40 Months
WhereTampa, Florida, United States
SponsorUniversity of South Florida
▾Tap for detailsClick for full details — eligibility, all locations, contacts JAB-30355 in Patients With Advanced Solid Tumors Harboring TP53 Y220C Mutation
NCT06386146 · Solid Tumors
RecruitingThis study is to evaluate the efficacy and safety of JAB-30355 in adult participants with advanced solid tumors harboring TP53 Y220C mutation.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereDenver, Colorado, United States + 14 more
SponsorJacobio Pharmaceuticals Co., Ltd.
▾Tap for detailsClick for full details — eligibility, all locations, contacts Safety and Efficacy of Intraperitoneal Injection of METR-NK Cells as Neoadjuvant Therapy for Advanced Epithelial Ovarian Cancer
NCT06395844 ·
Ovarian Cancer RecruitingThe goal of this type of clinical trial study is to evaluate the safety and efficacy of metabolic remodeling nature killer cells as neoadjuvant therapy in newly diagnosed patients with advanced ovarian cancer
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years – 70 Years
WhereHefei, Anhui, China
SponsorAnhui Provincial Cancer Hospital
▾Tap for detailsClick for full details — eligibility, all locations, contacts