A Study of ASP3082 in Adults With Previously Treated Solid Tumors
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|ClinicalTrials.gov Identifier: NCT05382559|
Recruitment Status : Recruiting
First Posted : May 19, 2022
Last Update Posted : August 2, 2022
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.
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: ASP3082||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||136 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study of ASP3082 in Participants With Previously Treated Locally Advanced or Metastatic Solid Tumor Malignancies With KRAS G12D Mutation|
|Actual Study Start Date :||June 8, 2022|
|Estimated Primary Completion Date :||May 31, 2026|
|Estimated Study Completion Date :||May 31, 2026|
Experimental: ASP3082 Dose Escalation (Part 1)
Participants will receive ASP3082 in a 21-day cycle.
Experimental: ASP3082 Dose Expansion (Part 2)
Participants will receive ASP3082 with dose level(s) selected from dose escalation (part 1) in a 21-day cycle.
- Incidence of Dose Limiting Toxicities (DLTs) [ Time Frame: Up to 21 Days ]A DLT is defined as any event meeting the DLT criteria occurring within 21 days of first dose on Cycle 1 Day 1 (C1D1), excluding toxicities clearly related to disease progression or intercurrent illness.
- Number of Participants with Adverse Events (AEs) [ Time Frame: Up to 50 months ]
An AE is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study IP, whether or not considered related to the study investigational product (IP).
Note: An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of study IP. This includes events related to the comparator and events related to the (study) procedures.
- Number of Participants with Serious Adverse Events (SAEs) [ Time Frame: Up to 50 months ]
An SAE is defined as any untoward medical occurrence that, at any dose:
Results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, and other medically important events.
- Number of Participants with laboratory value abnormalities and/or adverse events (AEs) [ Time Frame: Up to 48 months ]Number of participants with potentially clinically significant laboratory values.
- Number of Participants with electrocardiogram (ECG) abnormalities and/or adverse events (AEs) [ Time Frame: Up to 48 months ]Number of participants with potentially clinically significant ECG values.
- Number of Participants with vital sign abnormalities and/or adverse events (AEs) [ Time Frame: Up to 48 months ]Number of participants with potentially clinically significant vital sign values.
- Number of Participants with physical exam abnormalities and/or adverse events [ Time Frame: Up to 48 months ]Number of participants with potentially clinically significant physical exam values.
- Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status [ Time Frame: Up to 48 months ]The ECOG scale will be used to assess performance status. Grades range from 0 (fully active) to 5 (dead). Negative change scores indicate an improvement. Positive scores indicate a decline in performance.
- Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 [ Time Frame: Up to 48 months ]ORR is defined as the proportion of participants whose best overall response is rated as complete response (CR) or partial response (PR) per RECIST v1.1.
- Duration of Response (DOR) per RECIST v 1.1 [ Time Frame: Up to 48 months ]DOR is measured from the time measurement criteria are first met for CR/PR (whichever is first recorded) until the first date of documented radiological disease progression per RECIST v1.1 or death in the absence of progression.
- Disease Control Rate (DCR) per RECIST v 1.1 [ Time Frame: Up to 48 months ]DCR is defined as the proportion of participants whose best overall response is rated as CR, PR or SD based on RECIST v1.1.
- Pharmacokinetics (PK) of ASP3082 in plasma: Area under the concentration-time curve (AUC) [ Time Frame: Up to 48 months ]AUC will be recorded from the PK plasma samples collected.
- PK of ASP3082 in plasma: Maximum Concentration (Cmax) [ Time Frame: Up to 48 months ]Cmax will be recorded from the PK plasma samples collected.
- PK of ASP3082 in plasma: concentration immediately prior to dosing at multiple dosing (Ctrough) [ Time Frame: Up to 48 months ]Ctrough will be recorded from the PK plasma samples collected.
- PK of ASP3082 in plasma: Time of maximum concentration (tmax) [ Time Frame: Up to 48 months ]tmax will be recorded from the PK plasma samples collected.
- Changes in Kirsten rat sarcoma (KRAS) viral oncogene homolog G12D in tumor samples [ Time Frame: Up to 48 months ]Changes in KRAS G12D in tumor samples will be measured.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05382559
|Contact: Astellas Pharma Inc.||firstname.lastname@example.org|
|United States, Florida|
|Florida Cancer Specialists & Research Institute Sarasota||Recruiting|
|Sarasota, Florida, United States, 34232-6422|
|United States, New York|
|Columbia University - Herbert Irving Comprehensive Cancer Center||Recruiting|
|New York, New York, United States, 10032|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|United States, Tennessee|
|Sarah Cannon Research Institute||Recruiting|
|Nashville, Tennessee, United States, 37203|
|United States, Texas|
|San Antonio, Texas, United States, 78229|
|United States, Virginia|
|NEXT Oncology - Virginia Cancer Specialists||Recruiting|
|Fairfax, Virginia, United States, 22031|
|Study Director:||Medical Director||Astellas Pharma Inc|