Trial Summary
What is the purpose of this trial?This trial is testing INX-315, a new pill that blocks a protein helping cancer cells grow. It targets patients with advanced cancers who did not respond to other treatments. The drug aims to slow or stop cancer growth by blocking a key protein.
Is the drug INX-315 a promising treatment for advanced cancer?The information provided does not mention INX-315 or its effectiveness, so we cannot determine if it is a promising treatment for advanced cancer based on the given research articles.15789
Do I need to stop my current medications to join the trial?The trial protocol does not specify if you must stop all current medications, but you cannot take any prohibited medications or herbal remedies that cannot be discontinued at least 2 weeks before starting the study drug.
What safety data is available for INX-315 in advanced cancer treatment?The provided research does not directly mention INX-315 or its safety data. However, it discusses general safety and management of adverse events in cancer treatments, including immune-related adverse events and toxicities associated with targeted therapies. For specific safety data on INX-315, further investigation into clinical trial results or specific studies on INX-315 would be necessary.610111213
What data supports the idea that INX-315 for Advanced Cancer is an effective drug?The available research does not provide specific data on the effectiveness of INX-315 for Advanced Cancer. The studies mentioned focus on other treatments and combinations for different types of cancer, such as non-small cell lung cancer and metastatic breast cancer, but do not include information on INX-315.234514
Eligibility Criteria
This trial is for adults with advanced cancers, including hormone receptor positive breast cancer resistant to CDK4/6 inhibitors, ovarian cancer unresponsive to platinum-based treatments, and solid tumors with CCNE1 amplification after standard therapy. Participants must be in good physical condition (ECOG score of 0 or 1), have measurable lesions not previously treated by radiation, and adequate organ function.Inclusion Criteria
My ovarian cancer is resistant to platinum-based treatments and has worsened after standard treatment.
I am fully active or can carry out light work.
I have a tumor that can be measured and hasn't been treated with radiation.
My ER+/HER2- breast cancer has worsened after CDK4/6 inhibitor treatment.
My cancer has worsened after standard treatment or I cannot receive standard treatment.
My organ functions are within normal ranges according to recent tests.
Exclusion Criteria
My heart condition or high blood pressure is not well-managed, even with medication.
I have trouble swallowing or absorbing pills.
I have a heart condition that affects my heart's electrical activity.
I have not had intense radiotherapy in the last 28 days or any palliative radiotherapy in the last 2 weeks.
I am not planning to have any major surgery within 28 days of starting the study drug.
I do not have HIV/AIDS or any active, uncontrolled infections.
I have been treated with specific inhibitors for cancer before.
More than a quarter of my bone marrow has been exposed to radiation.
I have brain metastases or spinal issues needing steroids to manage symptoms.
My cancer has not spread to my brain or caused a severe crisis.
I have a known bleeding disorder or brain hemorrhage.
I have had a stem cell transplant after high-dose chemotherapy.
Treatment Details
INX-315 is being tested as an oral treatment targeting CDK2 in patients with various advanced cancers. The study has three parts: determining safe dosage levels (Part A), finding the recommended dose for Phase 2 trials in ovarian cancer patients (Part B), and testing INX-315 combined with other drugs in breast cancer patients who didn't respond to previous treatments (Part C).
4Treatment groups
Experimental Treatment
Group I: Part C: ER+/HER2- BC Dose ExpansionExperimental Treatment1 Intervention
INX-315 in combination with CDK4/6i and endocrine therapy, oral administration
Group II: Part B: Ovarian Dose ExpansionExperimental Treatment1 Intervention
INX-315 monotherapy, oral administration
Group III: Part A: Dose EscalationExperimental Treatment1 Intervention
Multiple doses of INX-315 monotherapy, oral administration
Group IV: Part A INX-315 + FulvestrantExperimental Treatment2 Interventions
INX-315 dose plus Fulvestrant 500mg
Find a clinic near you
Research locations nearbySelect from list below to view details:
Emory Winship Cancer InstituteAtlanta, GA
Dana-Farber Cancer InstituteBoston, MA
Levine Cancer Institute (LCI)- Atrium HealthCharlotte, NC
Gabrail Cancer Research CenterCanton, OH
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Who is running the clinical trial?
Incyclix BioLead Sponsor
References
[Optimal therapeutic strategies in ovarian epithelial cancer in 1997]. [2015]"Optimal" chemotherapy for advanced ovarian cancer has constantly evolved over the last 2 decades through the conduct of prospective randomized clinical trials. Because 3 such important trials have recently disclosed provocative results there are reasons to believe in the emergence of new "standard" treatment approaches for this disease towards the end of this century. 1) The Intergroup trial found a survival advantage for intraperitoneal cisplatin as compared to intravenous cisplatin following optimal debulking surgery. 2) In the EORTC-GCCG trial, which recruited patients with bulky disease at completion of primary surgery, survival was prolonged when interval debulking surgery was performed after 3 cycles of chemotherapy. 3) Paclitaxel-cisplatin was associated with a marked survival advantage in comparison with cisplatin-cyclophosphamide in the GOG trial, which enrolled suboptimally debulked patients. These trials clearly have important implications for the future management of ovarian cancer patients and from a health economy point of view: for these reasons, two of them (2 + 3) have been repeated by other groups, and results of these confirmatory trials should be available soon. There are a number of new treatment options for "Platinum-resistant" patients including docetaxel, topotecan, gemcitabine, oxaliplatin: but none of them is "optimal". An active search for new drugs in this setting remains a high priority. Finally, with the expanding knowledge of the molecular biology of cancer in general and ovarian cancer in particular, one can now start thinking of new molecular targets for treatment intervention including transmembrane tyrosine kinase growth factor receptors, matrix metalloproteinases, the vascular endothelial growth factor and so on....
Ifosfamide given by continuous-intravenous infusion in association with vinorelbine in patients with anthracycline-resistant metastatic breast cancer: a phase I-II clinical trial. [2020]Vinorelbine (VNR) is highly active in metastatic breast cancer (MBC) and has shown an overall response rate of 40%-50% as first-line treatment. In vitro, a synergy has been observed between this drug and ifosfamide (IFX). In addition, the pharmacokinetics of IFX suggest that it may have greater activity when given by continuous-intravenous infusion (c.i.v.i.). The aim of this study was, therefore, to assess the antitumor efficacy and toxicity of the combination of bolus VNR and c.i.v.i. IFX as second-line therapy in anthracycline-resistant breast cancer patients.
Optimizing chemotherapy and targeted agent combinations in NSCLC. [2019]Chemotherapy extends life and provides symptom palliation for patients with advanced non-small cell lung cancer (NSCLC). Numerous trials have been conducted that evaluate a variety of doublet regimens, but the majority of trials have found equal efficacy among the treatment arms. Indeed, a plateau appears to have been reached with respect to survival associated with traditional cytotoxic drug regimens. It was initially hoped that the addition of novel targeted agents to conventional chemotherapy would produce significant survival benefits for patients with advanced NSCLC; however, most trials have failed to show such a benefit. There is no survival benefit associated with adding erlotinib or gefitinib to a chemotherapy regimen, although there is a significant improvement in survival associated with erlotinib monotherapy in the second- and third-line advanced disease setting. In contrast, the results of E4599 clearly demonstrate that the addition of bevacizumab to paclitaxel-carboplatin chemotherapy extends survival in a select group of patients with non-squamous cell NSCLC. E4599 also represents a rational approach to drug development that could be modeled in other trials, namely, the use of a large, well designed, randomized trial prior to beginning a traditional phase II approach. This strategy can lead to the identification of subgroups most likely to benefit, as well as those that might experience increased toxicity, such as patients with squamous cell carcinoma treated with bevacizumab. Another approach to optimizing targeted therapy involves selecting a chemotherapy regimen with the greatest potential for synergy based on preclinical modeling. Because docetaxel has been shown to prolong survival in second-line treatment, a number of novel agents have been combined with docetaxel in order to improve efficacy. Alternatively, investigators have sought to combine novel agents with either carboplatin-paclitaxel or cisplatin-gemcitabine in first-line treatment. A number of trials are underway that combine these agents with inhibitors of the epidermal growth factor receptor (EGFR), vascular endothelial growth factor (VEGF), and the proteasome, as well as COX2 inhibitors, and novel immunomodulators.
Optimizing chemotherapy and targeted agent combinations in NSCLC. [2018]Chemotherapy extends life and provides symptom palliation for patients with advanced non-small cell lung cancer (NSCLC). Numerous trials have been conducted that evaluate a variety of doublet regimens, but the majority of trials have found equal efficacy among the treatment arms. Indeed, a plateau appears to have been reached with respect to survival associated with traditional cytotoxic drug regimens. It was initially hoped that the addition of novel targeted agents to conventional chemotherapy would produce significant survival benefits for patients with advanced NSCLC; however, most trials have failed to show such a benefit. There is no survival benefit associated with adding erlotinib or gefitinib to a chemotherapy regimen, although there is a significant improvement in survival associated with erlotinib monotherapy in the second- and third-line advanced disease setting. In contrast, the results of E4599 clearly demonstrate that the addition of bevacizumab to paclitaxel-carboplatin chemotherapy extends survival in a select group of patients with non-squamous cell NSCLC. E4599 also represents a rational approach to drug development that could be modeled in other trials, namely, the use of a large, well designed, randomized trial prior to beginning a traditional phase II approach. This strategy can lead to the identification of subgroups most likely to benefit, as well as those that might experience increased toxicity, such as patients with squamous cell carcinoma treated with bevacizumab. Another approach to optimizing targeted therapy involves selecting a chemotherapy regimen with the greatest potential for synergy based on preclinical modeling. Because docetaxel has been shown to prolong survival in second-line treatment, a number of novel agents have been combined with docetaxel in order to improve efficacy. Alternatively, investigators have sought to combine novel agents with either carboplatin-paclitaxel or cisplatin-gemcitabine in first-line treatment. A number of trials are underway that combine these agents with inhibitors of the epidermal growth factor receptor (EGFR), vascular endothelial growth factor (VEGF), and the proteasome, as well as COX2 inhibitors, and novel immunomodulators.
A phase II trial of triapine (NSC# 663249) and gemcitabine as second line treatment of advanced non-small cell lung cancer: Eastern Cooperative Oncology Group Study 1503. [2022]The objective of ECOG 1503 was to determine the response rate of this combination in the second-line treatment of advanced NSCLC.
Complying with the European Clinical Trials directive while surviving the administrative pressure - an alternative approach to toxicity registration in a cancer trial. [2019]The European Clinical Trials Directive of 2004 has increased the amount of paper work and reduced the number of initiated clinical trials. Particularly multinational trials have been delayed. To meet this challenge we developed a novel, simplified, fast and easy strategy for on-line toxicity registration for patients treated according to the Nordic/Baltic acute lymphoblastic leukaemia protocol, NOPHO ALL 2008, for children and young adults, including three randomisations. We used a risk-assessment based approach, avoiding reporting of expected adverse events and instead concentrating on 20 well-known serious, but rarer events with focus on changes in therapy introduced in the treatment protocol. This toxicity registration strategy was approved by the relevant regulatory authorities in all seven countries involved, as compliant within the EU directive of 2004. The centre compliance to registration was excellent with 98.9% of all patients being registered within 5weeks from the requested quarterly registration. Currently, four toxicities (thrombosis, fungal infections, pancreatitis and allergic reactions) have been chosen for further detailed exploration due to the cumulative fraction of patients with positive registrations exceeding 5%. This toxicity registration offers real-time toxicity profiles of the total study cohort and provides early warnings of specific toxicities that require further investigation.
Phase I dose-escalation study of MEDI-573, a bispecific, antiligand monoclonal antibody against IGFI and IGFII, in patients with advanced solid tumors. [2021]This phase I, multicenter, open-label, single-arm, dose-escalation, and dose-expansion study evaluated the safety, tolerability, and antitumor activity of MEDI-573 in adults with advanced solid tumors refractory to standard therapy or for which no standard therapy exists.
Safety, Pharmacokinetics, and Pharmacodynamics of a Humanized Anti-Semaphorin 4D Antibody, in a First-In-Human Study of Patients with Advanced Solid Tumors. [2022]Study objectives included evaluating the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and antitumor activity of VX15/2503 in advanced solid tumor patients.
Combination of paclitaxel, bevacizumab and MEK162 in second line treatment in platinum-relapsing patient derived ovarian cancer xenografts. [2019]Advanced ovarian cancer is very responsive to first line platinum therapy, however almost invariably it relapses with a resistant disease. We have reported that patient derived ovarian xenografts (PDXs), independently from the degree of the initial response to cisplatin (DDP), show a significantly lower response to a second DDP cycle. We here report the effect of new combination regimens containing a MEK inhibitor (MEK), bevacizumab (BEV) and paclitaxel (PTX) as second line therapy in platinum-relapsing PDXs.We selected three DDP-relapsing PDX models based on the presence of activation of the RAS/RAF/MEK/ERK axis, mutated p53, lack of PTEN expression and activation of the PI3K pathway. In all the selected xenograft models, the antitumor efficacy of the doublets can be summarized as PTX/BEV > BEV/MEK > PTX/MEK and the antitumor activity of the triple combination was higher than any double combination. All the different combinations were well tolerated. The present data corroborate the activity of bevacizumab in combination with chemotherapy for the treatment of relapsing ovarian tumors and suggest that the addition of another targeted agents (MEK inhibitor) can further increase the antitumor activity without any increase in toxicity. PDX models represent a useful model to test second line therapy after failure of DDP first line.
The 2016-2019 ImmunoTOX assessment board report of collaborative management of immune-related adverse events, an observational clinical study. [2020]We investigated the activities of an ImmunoTOX board, an academic, multidisciplinary group of oncologists and organ specialists that adopts a real-life, case-by-case approach in the management of patients with immune-related adverse events (irAEs).
Safety of Anticancer Agents Used in Children: A Focus on Their Off-Label Use Through Data From the Spontaneous Reporting System. [2022]Among factors influencing the higher risk of developing unknown or rare adverse drug reactions (ADRs) among children and adolescents, there is the frequent off-label use of drugs that seems to be very common in pediatric oncological patients. Our study aim to collect and evaluate data on the safety profile of antineoplastic drugs and their off-label use in the pediatrics population using real life data.
Management of toxicities associated with targeted therapies for acute myeloid leukemia: when to push through and when to stop. [2021]The recent advent of myriad targeted therapies for acute myeloid leukemia (AML) has led to new hope for our patients but has also introduced new challenges in managing the disease. For clinicians, the ability to treat AML in the outpatient setting with novel agents of equal or greater efficacy than 7+3 has been transformative. Despite the enthusiasm, however, the reality is that many patients are still frail and remain at risk for treatment-related complications. Translating the results of clinical trials into improved outcomes for these individuals requires an understanding of how best to manage the adverse effects of these agents. Which patients benefit most and what to watch for? When to stop therapy? Using illustrative case presentations, this review details the unique toxicities associated with each of the approved mutation-specific and nonspecific targeted drugs for AML. The goal of this review is to help clinicians determine the risk:benefit ratio in decision making for individual patients with AML.
Optimizing Care for Patients With Adverse Events From Immunotherapeutics. [2021]Immune-related adverse events (irAEs) are a common occurrence in patients treated with immune checkpoint inhibitors. Fortunately, the majority of irAEs are mild and easily managed with steroids. As the use of immune checkpoint inhibitors and other immune therapies continues to increase across indications, so too will the need for managing irAEs. Optimal care for irAEs should include surveillance and early detection, guideline-driven management of standard irAEs, multidisciplinary expert involvement in complicated or steroid-refractory cases, and concurrent research to define predictive biomarkers and delineate the populations, which can be safely treated and retreated with immune therapies. In this article, we describe the implementation of a 3-pronged strategy used at our institution consisting of an Immune Wellness Clinic to risk stratify and monitor at-risk patients, an Immuno-Oncology Treatment Monitoring Repository to support translational research, and an Immunotoxicity Tumor Board to manage severe or complicated adverse events.
A Phase 2 Clinical Trial of Combination Nivolumab, Ipilimumab, and Paclitaxel in Patients With Untreated Metastatic NSCLC: The OPTIMAL Trial. [2022]Most patients with advanced NSCLC will experience disease progression and death within 2 years. Novel approaches are needed to improve outcomes.