AGX101 for Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Angiex, Inc.
Must not be taking: CYP3A inhibitors, CYP3A inducers
Disqualifiers: Colorectal cancer, CNS tumors, others
No Placebo Group
Trial Summary
What is the purpose of this trial?AGX101 is an antibody-drug conjugate (ADC) therapy for tumor-forming cancers. The purpose of this study is to learn about AGX101 effects and safety at various dose levels in an all-comers advanced solid cancer patient population. AGX101will be administered intravenously.
Dosing of AGX101 will be repeated once every 3, 6 or 9 weeks. Participants may continue study treatment until disease progression, unacceptable toxicity, or consent withdrawal. Subjects will attend an end of treatment visit and will receive two safety follow-up telephone contacts up to 90 days following the last dose of study drug.
Do I need to stop my current medications for the AGX101 trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are on a potent CYP3A inhibitor or inducer and cannot switch to another medication. There are also specific time requirements since your last cancer treatment, such as a minimum of 2 weeks for most chemotherapy and 3 weeks for biologic therapy.
What is known about the safety of AGX101 for cancer treatment?
The safety of anti-PD-1 therapies, which include drugs like nivolumab and pembrolizumab, has been studied, showing they are generally better tolerated than traditional treatments, though they can still cause mild to severe side effects. These side effects are often related to the immune system and can affect the skin, lungs, and nervous system, but most are manageable. Long-term safety is still being studied, and there is a need for better ways to manage these side effects.
12345Eligibility Criteria
This trial is for individuals with advanced solid tumors, such as various types of breast cancer and pancreatic cancer. Participants should have a tumor that has not responded to standard treatments or has returned after treatment.Inclusion Criteria
LVEF ≥ 50%, as determined on cardiac ECHO or cardiac multiple-gated acquisition (MUGA) scan
My organs are working well.
Willing to authorize use of existing archival tissue, unless otherwise discussed with Sponsor
+5 more
Exclusion Criteria
I haven't had a severe cancer needing treatment in the last 3 years.
I have a serious heart condition.
I am currently taking antibiotics for an infection.
+13 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose Escalation
AGX-101 is administered in escalating doses to determine the maximum tolerated dose
21 days
Visits on Day 1 of every 3, 6, or 9-week cycle
Dose Expansion
AGX-101 is administered at a selected dose to a specific cancer type
Approximately 6 months and up to 3 years
Visits on Day 1 of every 3, 6, or 9-week cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 90 days following the last dose
End of treatment visit and two safety follow-up telephone contacts
Participant Groups
AGX101, an antibody-drug conjugate (ADC) designed to target and kill cancer cells, is being tested. Patients will receive AGX101 through an IV every three weeks until their disease progresses, they experience severe side effects, or choose to leave the study.
2Treatment groups
Experimental Treatment
Group I: Dose Expansion PhaseExperimental Treatment1 Intervention
AGX-101, initial 90-minute IV infusion, second 60-minute IV infusion and 30 minute subsequent IV infusions on Day 1 of every every 3, 6 or 9-week cycle in Dose Escalation Phase. Dose expansion will be carried out with a selected dose and selected cancer type.
Group II: Dose Escalation PhaseExperimental Treatment1 Intervention
AGX-101, initial 90-minute IV infusion, second 60-minute IV infusion and 30 minute subsequent IV infusions on Day 1 of every 3, 6 or 9-week cycle in Dose Escalation Phase. Dose escalation will be carried out in sequential cohorts of escalating doses, with an expansion cohort in advanced angiosarcoma.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Sarah Cannon Research CenterNashville, TN
NEXT OncologySan Antonio, TX
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Who Is Running the Clinical Trial?
Angiex, Inc.Lead Sponsor
References
Anti-PD-1 and anti-PD-L1 drugs treatment-related adverse events for patients with cancer: Protocol for an overview of systematic reviews with meta-analyses. [2023]Anti-programmed cell death 1 (PD-1) and anti-programmed cell death ligand 1 (PD-L1) drugs treatment-related adverse events (AEs) are not uniform based on current study for patients with cancer. The study aimed to provide a complete toxicity profile and toxicity spectrum for anti-PD-1 and anti-PD-L1 drugs.
The safety of anti PD-1 therapeutics for the treatment of melanoma. [2018]The introduction of immunotherapies into clinical practice has substantially improved the prognosis of metastatic melanoma patients as well as patients suffering from other cancers. The two FDA-approved checkpoint inhibitors against PD-1 (nivolumab and pembrolizumab) have been shown to significantly improve patient survival while being less toxic than previous treatment options. Areas covered: The current scientific literature on safety and adverse events (AEs) related to anti-PD-1 therapies has been investigated with special attention to case reports and to the latest results announced at the major clinical cancer and melanoma meetings, including ASCO (American Society of Clinical Oncology), ESMO (European Society of medical Oncology) and EADO (European Association of Dermato-Oncology) annual meetings. Expert opinion: Even though anti-PD-1 therapies are better tolerated than conventional chemo- or other immune-therapies, they still induce a plethora of AEs. Given the mechanism of action, it is supposed that most if not all of them are immune related. Fortunately, the majority are mild and manageable. However, due to the increase in patients' life expectancy, there is a substantial need to understand and prevent severe cutaneous, pulmonary, neurological and other AEs which have major impact on the quality of life. The safety profile after long term use of these medications is still unclear. In addition, non-steroid based immune interventions to control autoimmunity are still to be developed.
Targeted Toxicities: Protocols for Monitoring the Adverse Events of Targeted Therapies Used in the Treatment of Non-Small Cell Lung Cancer. [2023]Targeted therapies have revolutionized the treatment for many patients with non-small cell lung cancer (NSCLC). Multiple new oral targeted therapies have been approved in the last decade; however, their overall efficacy may be reduced by poor adherence, treatment interruptions, or dose reductions due to adverse events. Most institutions lack standard monitoring protocols for toxicities from these targeted agents. This review describes important adverse events observed in clinical trials and reported by the U.S. Food and Drug Administration for both currently approved and upcoming promising therapies in the treatment of NSCLC. These agents cause a range of toxicities, including dermatologic, gastroenteric, pulmonary, and cardiac toxicities. This review proposes protocols for routine monitoring of these adverse events, both prior to initiation of therapy and while on treatment.
Risk of serious adverse event and fatal adverse event with molecular target anticancer drugs in cancer patients: A meta-analysis. [2020]Molecular target anticancer drugs are commonly used in various forms of cancers. It is a concern that the risk of serious adverse events (SAEs) and fatal adverse events (FAEs) of molecular target drugs are increasing. An up-to-date meta-analysis of all Phase II/III/IV randomized trials of molecular target anticancer drugs was conducted to calculate the increased risk of SAEs and FAEs. A systematic search of PubMed, Web of Science, and Cochrane Library up to April 6, 2017, was conducted. The study enrolled Phase II/III/IV randomized trials of cancer that compared molecular target drugs alone versus placebo or performed single-arm analysis of molecular target drugs. Data on SAEs and FAEs were extracted from the included studies and pooled to compute risk ratio (RR), the overall incidence, and 95% confidence interval (CI). In this meta-analysis, a total of 19,965 and 26,642 patients in randomized 53 and 65 Phase II/II/IV trials were included in the analysis of SAEs and FAEs associated with molecular target anticancer drug, respectively. There were significant differences in the relationship of molecular target anticancer drugs with SAEs (RR = 1.57, 95% CI = 1.35-1.82, P < 0.01, I2 = 81%) and FAEs (RR = 1.51, 95% CI = 1.19-1.91, P < 0.01, I2 = 0%) compared to placebo. The overall incidence of SAEs and FAEs was 0.269 (95% CI = 0.262-0.276, P < 0.01) and 0.023 (95% CI = 0.020-0.025, P < 0.01), respectively. Molecular target anticancer drugs significantly increased the risk of SAEs and FAEs. For patients taking molecular target drugs, efforts are needed to prevent the occurrence of SAEs and FAEs.
Safety and tolerability of PD-1/PD-L1 inhibitors in the treatment of non-small cell lung cancer: a meta-analysis of randomized controlled trials. [2021]Significant improvement in survival outcome with the programmed death 1 (PD-1)/programmed death ligand 1 (PD-L1) inhibitors has been shown in advanced non-small cell lung cancer (NSCLC) patients compared with chemotherapy. However, the full spectrum of toxic events of PD-1/PD-L1 inhibitors was not well characterized. We conducted a comprehensive meta-analysis to state the safety profile of PD-1/PD-L1 inhibitors in NSCLC, and identify the exact incidence and relative risk (RR) of both summary and detailed AEs.