ASP3082 for Tumors, Solid

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Florida Cancer Specialists & Research Institute Sarasota, Sarasota, FL
Tumors, Solid+1 More
ASP3082 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

ASP3082 is a potential new treatment for people with certain solid tumors. Before ASP3082 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This information will help find a suitable dose and check for potential medical problems from the treatment. People in this study will be adults with locally advanced or metastatic solid tumors with changes in their KRAS gene (G12D mutation). Metastatic means the cancer has spread to other parts of the body. They will have been previously treated with all available standard therapies. There are 2 main aims of this study. The first is to learn if people with certain solid tumors have any medical problems after receiving different doses of ASP3082. The second is to find a suitable dose of ASP3082 to use in future studies. This study will be in 2 parts. In Part 1, different small groups of people will receive lower to higher doses of ASP3082. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP3082 to use in Part 2 of the study. The first group will receive the lowest dose of ASP3082. A medical expert panel will check the results from this group and decide if the next group can receive a higher dose of ASP3082. The panel will do this for each group until all groups have taken ASP3082 or until suitable doses have been selected for Part 2. In Part 2, other different small groups of people will receive ASP3082 with the most suitable doses worked out from Part 1. This will help find a more accurate dose of ASP3082 to use in future studies. ASP3082 will be given through a vein. This is called an infusion. Each treatment cycle is 21 days long. They will continue treatment until: they have medical problems from the treatment; their cancer gets worse; they start other cancer treatment; they ask to stop treatment; they do not come back for treatment. People will visit the clinic on certain days during their treatment, with extra visits during the first 2 cycles of treatment. During these visits, the study doctors will check for any medical problems from ASP3082. At some visits, other checks will include a medical examination, laboratory tests and vital signs. Vital signs include temperature, pulse, breathing rate, and blood pressure. Also, blood and urine samples will be taken. Tumor samples will be taken during certain visits during treatment and when treatment has finished. People will visit the clinic within 7 days after stopping treatment. The study doctors will check for any medical problems from ASP3082. Other checks will include a medical examination, laboratory tests and vital signs. Then, they may visit the clinic at 30 days and 90 days after stopping treatment. At the 30-day visit, the study doctors will check for any medical problems from ASP3082. People will have their vital signs checked and have some laboratory tests. At the 90-day visit, the study doctors will check for any medical problems from ASP3082 and people will have their vital signs checked. After this, people will continue to visit the clinic every 9 weeks. This is to check the condition of their cancer. They will do this until 45 weeks after treatment stopped, their cancer is worse, they start other cancer treatment, they ask to stop treatment, or they do not come back for treatment.

Eligible Conditions

  • Tumors, Solid

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Tumors, Solid

Study Objectives

8 Primary · 8 Secondary · Reporting Duration: Up to 50 months

Up to 21 Days
Incidence of Dose Limiting Toxicities (DLTs)
Up to 48 months
Changes in Kirsten rat sarcoma (KRAS) viral oncogene homolog G12D in tumor samples
Disease Control Rate (DCR) per RECIST v 1.1
Duration of Response (DOR) per RECIST v 1.1
Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status
Number of Participants with electrocardiogram (ECG) abnormalities and/or adverse events (AEs)
Number of Participants with laboratory value abnormalities and/or adverse events (AEs)
Number of Participants with physical exam abnormalities and/or adverse events
Number of Participants with vital sign abnormalities and/or adverse events (AEs)
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
PK of ASP3082 in plasma: Maximum Concentration (Cmax)
PK of ASP3082 in plasma: Time of maximum concentration (tmax)
PK of ASP3082 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough)
Pharmacokinetics (PK) of ASP3082 in plasma: Area under the concentration-time curve (AUC)
Up to 50 months
Number of Participants with Adverse Events (AEs)
Number of Participants with Serious Adverse Events (SAEs)

Trial Safety

Safety Progress

1 of 3

Other trials for Tumors, Solid

Trial Design

2 Treatment Groups

ASP3082 Dose Expansion (Part 2)
1 of 2
ASP3082 Dose Escalation (Part 1)
1 of 2
Experimental Treatment

136 Total Participants · 2 Treatment Groups

Primary Treatment: ASP3082 · No Placebo Group · Phase 1

ASP3082 Dose Expansion (Part 2)
Drug
Experimental Group · 1 Intervention: ASP3082 · Intervention Types: Drug
ASP3082 Dose Escalation (Part 1)
Drug
Experimental Group · 1 Intervention: ASP3082 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 50 months
Closest Location: Florida Cancer Specialists & Research Institute Sarasota · Sarasota, FL
Photo of florida 1Photo of florida 2Photo of florida 3
N/AFirst Recorded Clinical Trial
1 TrialsResearching Tumors, Solid
0 CompletedClinical Trials

Who is running the clinical trial?

Astellas Pharma IncLead Sponsor
678 Previous Clinical Trials
212,800 Total Patients Enrolled
4 Trials studying Tumors, Solid
313 Patients Enrolled for Tumors, Solid
Medical DirectorStudy DirectorAstellas Pharma Inc
2,597 Previous Clinical Trials
8,930,999 Total Patients Enrolled
30 Trials studying Tumors, Solid
6,314 Patients Enrolled for Tumors, Solid

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a locally advanced or metastatic solid tumor malignancy with documented KRAS G12D mutation and have progressed after receiving all available standard approved therapies.
You have an ECOG performance status of 0, 1 or 2.
You have adequate organ function as indicated by protocol laboratory value parameters.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.