YH42946 for Cancer
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Yuhan Corporation
Disqualifiers: Brain metastases, Heart failure, ILD, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this YH42946-101 is to evaluate the safety, Tolerability, Pharmacokinetics and anti-tumor activity of YH42946 in patients with locally advanced of metastatic solid tumors with HER2 aberration and EGFR exon 20 insertions.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What safety data exists for the treatment YH42946 for cancer?
The safety of molecular target anticancer drugs, which may include treatments like YH42946, shows an increased risk of serious adverse events (SAEs) and fatal adverse events (FAEs) compared to placebo. Efforts are needed to prevent these occurrences in patients taking such drugs.
12345Eligibility Criteria
This trial is for patients with advanced solid tumors, specifically those with HER2 or EGFR mutations who have exhausted standard treatments or can't receive them. Participants must have treated brain metastases if present, good kidney and liver function, stable blood counts without recent transfusions or growth factors, and a life expectancy of over 3 months.Inclusion Criteria
I am fully active or can carry out light work.
My doctor expects me to live at least 3 more months.
My cancer has worsened despite all standard treatments or standard treatments are not suitable for me.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose Escalation
Participants receive escalating doses of YH42946 to determine the maximum tolerated dose
21 days
Multiple visits for dose escalation and monitoring
Dose Expansion
Participants receive selected doses of YH42946 to evaluate efficacy and safety
Approximately 12 months
Regular visits for treatment and monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
Approximately 3.5 years
Participant Groups
The study tests YH42946's safety and effectiveness against advanced solid tumors with specific genetic changes. It's an early-phase trial assessing how the body processes the drug (pharmacokinetics) and its impact on tumor size (anti-tumor activity).
1Treatment groups
Experimental Treatment
Group I: Part 1 and Part 2Experimental Treatment1 Intervention
Part 1: Dose escalation arm to determine the MTD Part 2: Dose expansion part to select RD. Several independent cohorts are planned.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Next Oncology VirginiaFairfax, VA
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Who Is Running the Clinical Trial?
Yuhan CorporationLead Sponsor
References
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.
[Drug information brochure for patients undergoing FOLFOX 4 chemotherapy based on survey of adverse reactions]. [2013]We have been collecting data on the adverse reaction of FOLFOX 4 chemotherapy in our hospital from April 2005 to October retrospectively, by electronic clinical records. A retrospective study of 123 patients receiving FOLFOX 4 for advanced colorectal cancer was conducted. Survey results showed high incidences of hemotoxicity (52.8%), chronic sensory neuropathy (16.2%) and allergic reactions (15.4%). In the initial FOLFOX 4 therapy, appetite loss (60.1%), vomiting (19.5%) and acute sensory neuropathy (33.3%) were observed. We prepared a brochure in order to minimize inter-individual differences in pharmaceutical care and drug consultation by clinical pharmacists and to ensure the accurate understanding of patients. We feel sure that this kind of activity will help us to provide better pharmaceutical care for patients.
Pharmacotherapy follow-up of key points in the safety of oral antineoplastic agents. [2018]We assessed the impact of a pharmacotherapy follow-up programme on key safety points [adverse events (AE) and drug administration] in outpatients treated with oral antineoplastic agents (OAA). We performed a comparative, interventional, quasi-experimental study of outpatients treated with OAA in a Spanish hospital to compare pre-intervention group patients (not monitored by pharmacists during 2011) with intervention group patients (prospectively monitored by pharmacists during 2013). AE data were collected from medical records. Follow-up was 6 months, and 249 patients were included (pre-intervention, 115; intervention, 134). After the first month, AE were detected in 86.5% of patients in the pre-intervention group and 80.6% of patients in the intervention group, P = 0.096. During the remaining months, 79.0% patients had at least one AE in the pre-intervention group compared with 78.0% in the intervention group, P = 0.431. AE were more prevalent with sorafenib and sunitinib. In total, 173 drug interactions were recorded (pre-intervention, 80; intervention, 93; P = 0.045). Drug interactions were more frequent with erlotinib and gefitinib; food interactions were more common with sorafenib and pazopanib. Our follow-up of cancer outpatients revealed a reduction in severe AE and major drug interactions, thus helping health professionals to monitor the safety of OAA.
Adverse reactions associated with immune checkpoint inhibitors and bevacizumab: A pharmacovigilance analysis. [2023]Immune checkpoint inhibitors (ICIs) combined with the anti-angiogenesis drug bevacizumab is one of the future directions of immunotherapy. However, the potential adverse drug reactions (ADRs) caused by combination therapy remain unclear. Current research on ADRs of combination therapy in cancer patients is extremely limited. Our study aims to help determine the safety of combination therapy. We downloaded the ADR reports on combination therapy, from the first quarter of 2012 to the fourth quarter of 2021, from the FDA adverse event reporting system (FAERS) database and conducted a large-scale retrospective study. The ADR signals were monitored by reporting odds ratio (ROR) and analyzing the risk of different ADRs in patients with Pan-cancer. A total of 2094 cases were selected, after excluding duplicate data and the use of chemotherapy drugs. We evaluated the risk of ADR in Pan-cancer patients. Combination therapy was an independent risk factor for adverse drug reactions associated with interstitial lung disease (OR: 8.62; 95% CI: 6.14-12.10, P
Systematic Review of adverse events reporting in clinical trials leading to approval of targeted therapy and immunotherapy. [2020]Aim: Reporting toxicities of targeted therapies (TTs) and immunotherapy in oncology requires special attention. Materials & methods: We identified TTs and immunotherapies approved by the US FDA for solid malignancies in the adult population. Publications were reviewed according to a 24-point score based on the Consolidated Standards of Reporting Trials guidance. Results: We identified 81 trials (>45,000 patients). The experimental drug was studied as single agent in 51% of the cases; setting of disease was mainly (95%) advanced/metastatic. Lowest scores in adverse event (AE) description regarded: reporting recurrent/late toxicities and duration of the AEs (>90%), time of occurrence and indication of all-grade AEs (>75%). Conclusion: Suboptimal reporting of AEs in trials leading to approval of TTs and immunotherapy was shown. Improving AE descriptions should be a priority in ongoing trials.