541 Participants Needed

ASP3082 for Cancer

Recruiting at 48 trial locations
AP
Overseen ByAstellas Pharma Inc.
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Astellas Pharma Inc
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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.12345

Research Team

MD

Medical Director

Principal Investigator

Astellas Pharma Inc

Eligibility 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.
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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.
See 15 more

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

Treatment Details

Interventions

  • ASP3082
  • Cetuximab
Trial OverviewThe 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.
Participant Groups
10Treatment groups
Experimental Treatment
Group I: Treatment naive PDAC cohort ASP3082 + Nab-Paclitaxel + GemcitabineExperimental Treatment3 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 Treatment5 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 + Pembrolizumab - NSCLCExperimental Treatment2 Interventions
Participants with KRAS G12D mutant will receive ASP3082 in combination with pembrolizumab in a 21-day cycle.
Group VII: ASP3082 + Docetaxel - NSCLCExperimental Treatment2 Interventions
Participants with KRAS G12D mutant will receive ASP3082 in combination with docetaxel in a 21-day cycle.
Group VIII: 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 IX: 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.
Group X: ASP3082 + (Cisplatin or Carboplatin) and Pemetrexed +/- Pembrolizumab - NSCLCExperimental Treatment5 Interventions
Participants with KRAS G12D mutant will receive ASP3082 in combination with platinum-based chemotherapy (cisplatin or carboplatin) and pemetrexed, with or without pembrolizumab in a 21-day cycle.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Astellas Pharma Inc

Lead Sponsor

Trials
700
Recruited
236,000+
Headquarters
Tokyo, Japan
Top Products
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Tadaaki Taniguchi profile image

Tadaaki Taniguchi

Astellas Pharma Inc

Chief Medical Officer since 2023

MD, PhD

Naoki Okamura profile image

Naoki Okamura

Astellas Pharma Inc

Chief Executive Officer since 2023

University of Tokyo, Faculty of Pharmacy

Findings from Research

A total of 3120 adverse event cases related to avapritinib were reported to the FDA, with 44% occurring within the first 30 days of treatment, highlighting the importance of monitoring patients closely during this period.
The study found that elderly male patients are at a higher risk for serious adverse events, indicating that clinicians should exercise caution when prescribing avapritinib to this demographic.
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.Rong, L., Xie, M., Jiang, M., et al.[2023]
A meta-analysis of 53 Phase II/III/IV trials involving nearly 20,000 patients revealed that molecular target anticancer drugs significantly increase the risk of serious adverse events (SAEs) by 57% and fatal adverse events (FAEs) by 51% compared to placebo.
The overall incidence rates for SAEs and FAEs were found to be 26.9% and 2.3%, respectively, highlighting the need for careful monitoring and preventive measures for patients receiving these treatments.
Risk of serious adverse event and fatal adverse event with molecular target anticancer drugs in cancer patients: A meta-analysis.Wang, Z., Yang, X., Wang, J., et al.[2020]
In a study of 66 patients with operable stage III non-small cell lung cancer (NSCLC), the combination of Camrelizumab with Docetaxel and Cisplatin showed good overall safety, with most adverse events (AEs) being mild (grade 1-2) and only 9.1% being severe (grade 3-4).
The supervision of adverse events during neoadjuvant therapy not only helped in managing complications but also led to an improvement in patients' quality of life, indicating that careful monitoring can enhance treatment outcomes.
[Role of Adverse Events Supervision in Clinical Trials in Neoadjuvant Treatment of Operable Stage III NSCLC].Zhang, Y., Zhou, S., Tao, W., et al.[2023]

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]
Risk of serious adverse event and fatal adverse event with molecular target anticancer drugs in cancer patients: A meta-analysis. [2020]
[Role of Adverse Events Supervision in Clinical Trials in Neoadjuvant Treatment of Operable Stage III NSCLC]. [2023]
Development and Evaluation of a Data-Driven, Interactive Workshop to Facilitate Communication and Teamwork in Ambulatory Medical Oncology Settings. [2023]
Trends in patient-reported outcome use in early phase dose-finding oncology trials - an analysis of ClinicalTrials.gov. [2023]