Study of Safety and Tolerability of BCA101 Monotherapy and in Combination Therapy in Patients With EGFR-driven Advanced Solid Tumors
NCT04429542 · Head and Neck Squamous Cell Carcinoma, Squamous Cell Carcinoma of Anal Canal, Colorectal Cancer
RecruitingThe investigational drug to be studied in this protocol, BCA101, is a first-in-class compound that targets both EGFR with TGFβ. Based on preclinical data, this bifunctional antibody may exert synergistic activity in patients with EGFR-driven tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WhereLa Jolla, California, United States + 19 more
SponsorBicara Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Assess IPN01194 When Administered Alone in Adults With Advanced Solid Tumours
NCT06305247 · Melanoma, Head and Neck Squamous Cell Carcinoma, Pancreatic Ductal Adenocarcinoma
RecruitingThe purpose of this study is to determine the appropriate dosage, safety and effectiveness of the study drug, IPN01194 in adults with advanced solid tumours. The participants in this study will have advanced solid tumours. 'Advanced solid tumours' refers to cancers that can occur in several places, including cancers in organs or tissues that have spread from their original site to nearby tissues or other parts of the body. In this study, all participants will receive the study drug, which will be taken by mouth (orally).
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 11 more
SponsorIpsen
▾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 Study of LY4170156 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, LY4170156, is safe, tolerable and effective in participants with advanced solid tumors. The study is conducted in two parts - phase Ia (dose-escalation, dose-optimization) and phase Ib (dose-expansion). The study will last up to approximately 4 years.
PhasePhase 1
TypeInterventional
Age18 Years
WhereScottsdale, Arizona, United States + 22 more
SponsorEli Lilly and Company
▾Tap for detailsClick for full details — eligibility, all locations, contacts Solid Tumor Analysis for HLA Loss of Heterozygosity (LOH) and Apheresis for CAR T- Cell Manufacturing
NCT04981119 · Solid Tumor, Adult, Colorectal Cancer, Non Small Cell Lung Cancer
RecruitingObjective: To collect information on how often a solid tumor cancer might lose the Human Leukocyte Antigen (HLA) by next generation sequencing and perform apheresis to collect and store an eligible participant's own T cells for future use to make CAR T-Cell therapy for their disease treatment. Design: This is a non-interventional, observational study to evaluate participants with solid tumors with a high risk of relapse for incurable disease. No interventional therapy will be administered on this study. Some of the information regarding the participant's tumor analysis may be beneficial to management of their disease. Participants that meet all criteria may be enrolled and leukapheresed (blood cells collected). The participant's cells will be processed and stored for potential manufacture of CAR T-cell therapy upon relapse of their cancer.
Phase—
TypeObservational
Age18 Years
WhereGilbert, Arizona, United States + 15 more
SponsorA2 Biotherapeutics Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Trial to Evaluate the Safety and Activity of Fruquintinib in Minority Populations With Advanced, Previously Treated Colorectal Cancer
NCT06562543 · Colorectal Cancer
RecruitingHigh blood pressure (hypertension) is a known side effect of the treatment with fruquintinib. Current research does not provide a clear answer whether minority groups such as Black/African American and/or Hispanic/Latino with refractory metastatic colorectal cancer (mCRC) have a bigger risk of higher blood pressure after treatment with fruquintinib. The main aim of this study is to learn how often adults of a minority group experience hypertension after they have been treated with fruquintinib for refractory mCRC. Other aims are to learn how safe fruquintinib is and how well it is tolerated by participants. Participants will receive fruquintinib in 4-week treatment cycles until their condition worsens, they do no longer tolerate the treatment or stop the treatment for other reasons. After the last treatment, participants will be checked upon every 3 months until study completion.
PhasePhase 4
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 44 more
SponsorTakeda
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
NCT05253651 · Colorectal Neoplasms
RecruitingThis study is being done to find out if tucatinib with other cancer drugs works better than standard of care to treat participants with HER2 positive colorectal cancer. This study will also determine what side effects happen when participants take this combination of drugs. A side effect is anything a drug does to the body besides treating your disease. Participants in this study have colorectal cancer that has spread through the body (metastatic) and/or cannot be removed with surgery (unresectable). Participants will be assigned randomly to the tucatinib group or standard of care group. The tucatinib group will get tucatinib, trastuzumab, and mFOLFOX6. The standard of care group will get either: * mFOLFOX6 alone, * mFOLFOX6 with bevacizumab, or * mFOLFOX6 with cetuximab mFOLFOX6 is a combination of multiple drugs. All of the drugs given in this study are used to treat this type of cancer.
PhasePhase 3
TypeInterventional
Age18 Years
WhereGlendale, Arizona, United States + 381 more
SponsorSeagen, a wholly owned subsidiary of Pfizer
▾Tap for detailsClick for full details — eligibility, all locations, contacts Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
NCT05080673 · Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum
RecruitingThis trial examines colorectal cancer incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.
PhaseNA
TypeInterventional
Age45 Years – 70 Years
WhereFairbanks, Alaska, United States + 479 more
SponsorNRG Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts Testing the Combination of the Anti-Cancer Drugs Temozolomide and M1774 to Evaluate Their Safety and Effectiveness
NCT05691491 · Advanced Malignant Solid Neoplasm, Advanced Microsatellite Stable Colorectal Carcinoma, Hematopoietic and Lymphatic System Neoplasm
RecruitingThis phase I/II trial studies the side effects and best dose of temozolomide and M1774 and how well they works in treating patients with cancer that has spread from where it first started (primary site) to other places in the body (metastatic) and may have spread to nearby tissue, lymph nodes, or distant parts of the body (advanced). Temozolomide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill tumor cells and slow down or stop tumor growth. M1774 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Adding M1774 to temozolomide may shrink or stabilize cancer for longer than temozolomide alone.
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereIrvine, California, United States + 22 more
SponsorNational Cancer Institute (NCI)
▾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
NCT07216105 · Non-Small Cell Lung Cancer, Colorectal Cancer, Breast Cancer
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 Early Detection of Advanced Adenomas and Colorectal Cancer
NCT06342440 · Colorectal Cancer, Colorectal Neoplasms, Colorectal Polyp
RecruitingThis study aims to develop a highly sensitive, specific, and cost-effective blood assay for early detection of colorectal adenomas and cancer, using advanced machine learning and state-of-the-art biological analyses.
Phase—
TypeObservational
Age18 Years
WhereMonrovia, California, United States + 5 more
SponsorCity of Hope Medical Center
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of CRX100 as Monotherapy and in Combination With Pembrolizumab in Patients With Advanced Solid Malignancies
NCT04282044 · Solid Tumor, Adult, Triple Negative Breast Cancer, Colorectal Cancer
RecruitingThis clinical study is an open-label, Phase 1, dose-escalation study to determine the safety, tolerability, and efficacy of the drug product produced by Administering CRX100 alone and in combination with Pembrolizumab in advanced solid malignancies. Patients will be screened and evaluated to determine whether or not they meet stated inclusion criteria. Enrolled subjects will undergo leukapheresis to enable the ex vivo generation of CRX100. Patients with non-small cell lung cancer (NSCLC), ovarian cancer, colorectal cancer, hepatocellular carcinoma (HCC), malignant melanoma (excluding uveal melanoma), gastric cancer, triple negative breast cancer, and osteosarcoma. The study will start with monotherapy dose escalation followed by combination cohorts.
PhasePhase 1
TypeInterventional
Age18 Years
WhereScottsdale, Arizona, United States + 2 more
SponsorBioEclipse Therapeutics
▾Tap for detailsClick for full details — eligibility, all locations, contacts Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors
NCT06625775 · Solid Tumor, Adult, Metastatic Breast Cancer, Advanced Breast Cancer
RecruitingFirst in human study to evaluate the safety, tolerability, and pharmacokinetics (PK) of BBO-10203, a PI3Kα:RAS breaker, alone and in combination with other anti-cancer agents in patients with advanced solid tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 35 more
SponsorTheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of JANX008 in Subjects With Advanced or Metastatic Solid Tumor Malignancies
NCT05783622 · Non-Small Cell Lung Cancer, Renal Cell Carcinoma, Squamous Cell Carcinoma of the Head and Neck
RecruitingThis study is a first-in-human (FIH), Phase 1/1b, open-label, multicenter dose escalation and dose expansion study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary anti-tumor activity of JANX008 in adult subjects with advanced or metastatic carcinoma expressing EGFR.
PhasePhase 1
TypeInterventional
Age18 Years – 100 Years
WhereDuarte, California, United States + 17 more
SponsorJanux Therapeutics
▾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 + 75 more
SponsorPMV Pharmaceuticals, Inc
▾Tap for detailsClick for full details — eligibility, all locations, contacts Colon Adjuvant Chemotherapy Based on Evaluation of Residual Disease
NCT05174169 · Stage III Colon Cancer
RecruitingThis Phase II/III trial will evaluate the what kind of chemotherapy to recommend to patients based on the presence or absences of circulating tumor DNA (ctDNA) after surgery for colon cancer.
PhasePhase 2 / Phase 3
TypeInterventional
Age18 Years
WhereBirmingham, Alabama, United States + 1053 more
SponsorNRG Oncology
▾Tap for detailsClick for full details — eligibility, all locations, contacts Surveillance Colonoscopy in Older Adults: The SurvOlderAdults Study
NCT05994482 · Colorectal Cancer
RecruitingColorectal cancer is a leading cause of cancer death. Detection and removal of polyps can reduce risk for developing colorectal cancer. After finding and removing precancerous polyps, repeat colonoscopy is routinely recommended. However, it is unclear whether repeat additional colonoscopy further reduces risk for colorectal cancer. For older adults age 75 and older, the lack of this information is especially important, given that the risks of colonoscopy go up with age. This research will evaluate whether older adults with a prior history of precancerous polyps have higher colorectal cancer risks compared to older adults who had a prior normal colonoscopy, and whether, among those with prior precancerous polyps, repeating a colonoscopy after age 75 is associated with reduced cancer risk. The investigators will synthesize these data and gather perspectives from Veterans and clinical stakeholders to make recommendations on whether older adults with a prior history of polyps should continue or defer colonoscopy after age 75.
Phase—
TypeObservational
Age75 Years
WhereSan Diego, California, United States + 1 more
SponsorVA Office of Research and Development
▾Tap for detailsClick for full details — eligibility, all locations, contacts BBO-11818 in Adult Subjects With KRAS Mutant Cancer
NCT06917079 · Non-Small Cell Lung Cancer, NSCLC, PDAC - Pancreatic Ductal Adenocarcinoma
RecruitingA first in human study to evaluate the safety and preliminary antitumor activity of BBO-11818, a pan-KRAS inhibitor, in subjects with locally advanced unresectable or metastatic KRAS mutant solid tumors.
PhasePhase 1
TypeInterventional
Age18 Years
WhereLos Angeles, California, United States + 10 more
SponsorTheRas, Inc., d/b/a BBOT (BridgeBio Oncology Therapeutics)
▾Tap for detailsClick for full details — eligibility, all locations, contacts Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors
NCT06445062 · Colorectal Cancer, CRC, Pancreatic Ductal Adenocarcinoma
RecruitingThe purpose of this platform study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary antitumor activity of novel RAS(ON) inhibitors combined with Standard(s) of Care (SOC) or with novel agents. The current subprotocols include the following: Subprotocol A: RMC-6236 + 5-fluorouracil-based regimens Subprotocol B: RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol C: RMC-6236 + gemcitabine + nab-paclitaxel Subprotocol D: RMC-9805 with or without RMC-6236 + 5-fluorouracil-based regimens Subprotocol E: RMC-9805 with or without RMC-6236 + cetuximab with or without mFOLFOX6 Subprotocol F: RMC-9805 with or without RMC-6236 + gemcitabine + nab-paclitaxel
PhasePhase 1 / Phase 2
TypeInterventional
Age18 Years
WhereChandler, Arizona, United States + 31 more
SponsorRevolution Medicines, Inc.
▾Tap for detailsClick for full details — eligibility, all locations, contacts