M9466 + Tuvusertib for Cancer
Palo Alto (17 mi)Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: EMD Serono Research & Development Institute, Inc.
No Placebo Group
Trial Summary
What is the purpose of this trial?The purpose of this study is to evaluate the safety, tolerability, pharmacokinetic, pharmacodynamic profile of M9466 with and without tuvusertib or an ARPi and early signs of clinical activity of M9466 with tuvusertib in participants with advanced solid tumors. Study details include: Study/Treatment Duration: Participants will be treated until disease progression, death, discontinuation, or End of Study. Visit Frequency: Every week in the first 2 cycles, followed by every 3 weeks in the subsequent cycles. An End of Treatment Visit and Safety Follow-up/Discontinuation Visit are scheduled after the treatment period.
What safety data is available for the cancer treatment M9466 + Tuvusertib?The provided research does not contain specific safety data for M9466, HRS-1167, Tuvusertib, or M1774. The studies mentioned focus on other drugs like adavosertib, pimasertib, and tucatinib, which are not directly related to the treatment in question.69111213
Is the drug M9466, Tuvusertib a promising treatment for cancer?The information provided does not include any details about the drug M9466, Tuvusertib, so we cannot determine if it is a promising treatment for cancer based on the given research articles.23478
What data supports the idea that M9466 + Tuvusertib for Cancer is an effective treatment?The available research does not provide specific data on the effectiveness of M9466 + Tuvusertib for Cancer. Instead, it focuses on other treatments for different types of cancer, such as ramucirumab plus erlotinib for lung cancer and ramucirumab plus FOLFIRI for colorectal cancer. Without direct data on M9466 + Tuvusertib, we cannot conclude its effectiveness compared to these other treatments.15101415
Do I need to stop my current medications to join the trial?The trial requires a washout period of 4 weeks (or 6 weeks for certain drugs) for those who have received chemotherapy, extensive radiotherapy, biological therapy, or investigational agents before starting the study. If you are on ongoing ADT with a GnRH agonist or antagonist for prostate cancer, you must continue it throughout the study. The protocol does not specify other medications, so consult with the study team for guidance.
Eligibility Criteria
This trial is for individuals with advanced solid tumors. Participants will receive treatment until their disease progresses, they pass away, decide to leave the study, or when the study ends. They'll visit the clinic weekly at first and then every three weeks.Inclusion Criteria
My cancer is advanced and hasn't responded to standard treatments.
I can carry out all my self-care but cannot do heavy physical work.
I haven't had certain cancer treatments for a specific time before starting the study drug.
Exclusion Criteria
I have had a stroke.
Treatment Details
The trial is testing M9466 alone or combined with Tuvusertib on patients with advanced solid tumors. It aims to assess safety, how well it's tolerated, how it affects and moves within the body (pharmacokinetics/pharmacodynamics), and its initial effectiveness.
3Treatment groups
Experimental Treatment
Group I: M9466 with AA-P(abiraterone acetate and prednisone or prednisolone)Experimental Treatment2 Interventions
Group II: M9466 plus TuvusertibExperimental Treatment2 Interventions
Group III: M9466 MonotherapyExperimental Treatment1 Intervention
Find a clinic near you
Research locations nearbySelect from list below to view details:
NEXT Oncology - PARENTNew York, NY
The University of Texas MD Anderson Cancer CenterHouston, TX
Please Contact U.S. Medical InformationRockland, MA
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Who is running the clinical trial?
EMD Serono Research & Development Institute, Inc.Lead Sponsor
Merck KGaA, Darmstadt, GermanyIndustry Sponsor
References
Randomized phase II study of erlotinib plus tivantinib versus erlotinib plus placebo in previously treated non-small-cell lung cancer. [2022]c-MET (MET) receptor activation is associated with poor prognosis and epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) resistance in non-small-cell lung cancer (NSCLC). This global, randomized phase II trial examined erlotinib plus tivantinib (ARQ 197; ArQule, Woburn, MA), a novel MET inhibitor.
Ramucirumab plus docetaxel versus placebo plus docetaxel for second-line treatment of stage IV non-small-cell lung cancer after disease progression on platinum-based therapy (REVEL): a multicentre, double-blind, randomised phase 3 trial. [2023]Ramucirumab is a human IgG1 monoclonal antibody that targets the extracellular domain of VEGFR-2. We aimed to assess efficacy and safety of treatment with docetaxel plus ramucirumab or placebo as second-line treatment for patients with stage IV non-small-cell-lung cancer (NSCLC) after platinum-based therapy.
Ramucirumab: preclinical research and clinical development. [2023]Ramucirumab (IMC-1121B, LY3009806), a fully humanized monoclonal antibody directed against the extracellular domain of vascular endothelial growth factor receptor 2 (VEGFR-2), is a new therapeutic option that selectively inhibits the human VEGFR-2 with a much greater affinity than its natural ligands. Based on the promising results of both preclinical and early clinical studies, ramucirumab has been tested in different tumor types either alone or in combination with chemotherapy. While it has recently been granted its first US Food and Drug Administration approval for use as a single agent in patients with advanced or metastatic gastric cancer or gastroesophageal junction carcinoma, its role for metastatic breast cancer or advanced non-small-cell lung cancer is still debated. The aims of this review are to recall and discuss the most significant preclinical and clinical studies that led to the development of ramucirumab and to present the results of the randomized clinical trials that have tested its efficacy in different malignancies, including gastric and lung cancer.
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Subgroup analysis in RAISE: a randomized, double-blind phase III study of irinotecan, folinic acid, and 5-fluorouracil (FOLFIRI) plus ramucirumab or placebo in patients with metastatic colorectal carcinoma progression. [2023]The RAISE phase III clinical trial demonstrated that ramucirumab + FOLFIRI improved overall survival (OS) [hazard ratio (HR) = 0.844, P = 0.0219] and progression-free survival (PFS) (HR = 0.793, P
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FDA Approval Summary: Tucatinib for the Treatment of Patients with Advanced or Metastatic HER2-positive Breast Cancer. [2022]On April 17, 2020, the FDA approved tucatinib in combination with trastuzumab and capecitabine for the treatment of patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. This was the first new molecular entity evaluated under Project Orbis, an FDA Oncology Center of Excellence initiative, which supports concurrent review of oncology drugs by multiple global health authorities. Approval was based on the HER2CLIMB trial, which randomized patients to receive tucatinib or placebo with trastuzumab and capecitabine. Tucatinib demonstrated efficacy compared with placebo in progression-free survival [PFS; HR: 0.54; 95% confidence interval (CI): 0.42-0.71; P < 0.00001] and overall survival (OS; HR: 0.66; 95% CI, 0.50-0.87; P = 0.00480). Patients with either treated and stable or active brain metastases made up 48% of the study population. PFS in patients with brain metastases confirmed benefit (HR: 0.48; 95% CI, 0.34-0.69; P < 0.00001). The benefit in patients with brain metastases allowed for inclusion of this specific population in the indication. Important safety signals included diarrhea and hepatotoxicity which are listed under Warnings and Precautions. This article summarizes the FDA thought process and data supporting the favorable benefit-risk profile and approval of tucatinib.
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Adavosertib with Chemotherapy in Patients with Primary Platinum-Resistant Ovarian, Fallopian Tube, or Peritoneal Cancer: An Open-Label, Four-Arm, Phase II Study. [2022]This study assessed the efficacy, safety, and pharmacokinetics of adavosertib in combination with four chemotherapy agents commonly used in patients with primary platinum-resistant ovarian cancer.
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