ASP3082 for Cancer
Recruiting in Palo Alto (17 mi)
+45 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Astellas Pharma Inc
Must not be taking: KRAS inhibitors
Disqualifiers: CNS metastases, Active hepatitis, HIV, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial is testing a new drug called ASP3082 for adults with advanced cancers. The drug works by blocking harmful proteins. The study will determine the best dose and check for any side effects.
Will I have to stop taking my current medications?
The trial protocol does not specify if you need to stop taking your current medications. However, you must have completed any prior cancer treatments at least 21 days before starting the study, and any radiotherapy at least 14 days prior. It's best to discuss your specific medications with the study team.
What safety data exists for ASP3082 and related treatments?
The research does not provide specific safety data for ASP3082 or its related treatments like Cetuximab. However, it mentions that molecular target anticancer drugs, in general, have an increased risk of serious and fatal adverse events compared to placebo, indicating a need for careful monitoring.
12345Eligibility Criteria
Adults with advanced solid tumors that can't be removed by surgery or have spread, and who have a specific mutation (KRAS G12D) after standard treatments or refusal of such therapies. They must be in good physical condition, not pregnant, agree to contraception use, and have recovered from previous treatment side effects.Inclusion Criteria
I agree to provide recent or archived tumor samples for the study.
I will not donate eggs during and for 6 months after the study.
I finished any radiotherapy 14 days ago, have no side effects, and don't need steroids.
+15 more
Exclusion Criteria
I have brain metastases but they are either symptom-free or treated.
I will need additional cancer treatment while on the study.
I haven't needed treatment for another cancer in the last 2 years, except for certain skin, bladder, cervix, or breast conditions.
+15 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Dose Escalation (Part 1)
Participants receive escalating doses of ASP3082, alone or with cetuximab, to determine suitable doses for Part 2
21-28 days per cycle
Weekly visits for cetuximab administration
Dose Expansion (Part 2)
Participants receive ASP3082, alone or in combination with chemotherapy agents, at doses determined in Part 1
21-28 days per cycle
Follow-up
Participants are monitored for safety and effectiveness after treatment
Up to 48 months
Participant Groups
The trial is testing ASP3082 alone and combined with cetuximab in adults with certain solid tumors having the KRAS G12D mutation. It's an open-label study where participants know what they're receiving. The goal is to determine safe dosages and monitor how well patients tolerate the treatments over multiple cycles.
7Treatment groups
Experimental Treatment
Group I: Treatment naive PDAC cohort ASP3082 + Nab-Paclitaxel + GemcitabineExperimental Treatment2 Interventions
Upon completion of dose escalation (part 1), participants with KRAS G12D mutant will receive ASP3082 in combination with Nab-P + GEM (nanoparticle albumin-bound-paclitaxel plus gemcitabine) with dose level(s) selected from dose escalation (part 1) in a 28-day cycle.
Group II: Treatment naive PDAC cohort ASP3082 + FOLFIRINOXExperimental Treatment4 Interventions
Upon completion of dose escalation (part 1), participants with KRAS G12D mutant will receive ASP3082 in combination with FOLFIRINOX (leucovorin \[LV\]/fluorouracil \[5-FU\]/irinotecan/oxaliplatin) with dose level(s) selected from dose escalation (part 1) in a 28-day cycle.
Group III: ASP3082 Dose Expansion (Monotherapy Part 2)Experimental Treatment1 Intervention
Participants will receive ASP3082 with dose level(s) selected from dose escalation (part 1) in a 21-day cycle.
Group IV: ASP3082 Dose Escalation (Monotherapy Part 1)Experimental Treatment1 Intervention
Participants will receive ASP3082 in a 21-day cycle.
Group V: ASP3082 China Safety CohortExperimental Treatment1 Intervention
Participants will receive ASP3082 with dose level selected from dose escalation (Monotherapy part 1) in a 21-day cycle.
Group VI: ASP3082 + Cetuximab Dose Expansion (Combination Therapy Part 2)Experimental Treatment2 Interventions
Participants will receive ASP3082 or ASP3082 + Cetuximab with dose level(s) selected from dose escalation (part 1) in a 21-day cycle. Cetuximab will be administered weekly.
Group VII: ASP3082 + Cetuximab Dose Escalation (Combination Therapy Part 1)Experimental Treatment2 Interventions
Participants will receive ASP3082 in a 21-day cycle. Cetuximab will be administered weekly.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Roswell Park Cancer InstituteBuffalo, NY
Washington University School of MedicineSaint Louis, MO
SCRI Oncology PartnersNashville, TN
Premiere OncologySanta Monica, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Astellas Pharma IncLead Sponsor
References
A post-marketing pharmacovigilance study of avapritinib: Adverse event data mining and analysis based on the United States Food and Drug Administration Adverse Event Reporting System database. [2023]Avapritinib was first approved by the FDA in January 2020 and represents the first precision-targeted drug for gastrointestinal stromal tumours. However, there is a lack of large-scale data relating to adverse events (AEs) related to its use. We aimed to explore the avapritinib-related AEs in real-world practice based on the post-marketing data.
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.
[Role of Adverse Events Supervision in Clinical Trials in Neoadjuvant Treatment of Operable Stage III NSCLC]. [2023]Programmed cell death protein 1 (PD-1) combined with platinum containing dual drug chemotherapy is a new adjuvant treatment option for operable stage III non-small cell lung cancer (NSCLC), and the quality assurance of clinical trials of related drugs plays a crucial role in the results of the clinical trials. This study aims to explore the impact of adverse events (AEs) supervision on reducing treatment-related AEs in patients.
Development and Evaluation of a Data-Driven, Interactive Workshop to Facilitate Communication and Teamwork in Ambulatory Medical Oncology Settings. [2023]While adverse events and toxicities related to cancer drug therapy in the ambulatory oncology setting are common and often rooted in communication challenges, few studies have examined the problems of communication or tested tools to improve communication in this unique, high-risk setting.
Trends in patient-reported outcome use in early phase dose-finding oncology trials - an analysis of ClinicalTrials.gov. [2023]Patient-reported adverse events (AEs) may be a useful adjunct to clinician-assessed AEs for assessing tolerability in early phase, dose-finding oncology trials (DFOTs). We reviewed DFOTs on ClinicalTrials.gov to describe trends in patient-reported outcome (PRO) use.