ASP2998 for Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called ASP2998 for individuals with certain types of advanced cancer that cannot be surgically removed. ASP2998 targets a protein called TROP2, which aids tumor growth and spread. The primary goal is to determine the safety and tolerability of ASP2998, both alone and in combination with other cancer treatments. Individuals with solid tumors such as bladder, lung, gastric, or certain breast cancers may be suitable candidates, particularly if their cancer has progressed after other treatments. Participants should not have cancer that has spread to the brain's lining or require immune-suppressing medications. As a Phase 1, Phase 2 trial, this research aims to understand how ASP2998 functions in people and to measure its effectiveness in an initial group, offering participants an opportunity to contribute to groundbreaking cancer treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you cannot participate if you need medicines to suppress your immune system or if you are receiving certain treatments like anticoagulants. It's best to discuss your specific medications with the trial team.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that ASP2998 is being tested to target a specific protein called TROP2, often found in solid tumors. This marks the first time ASP2998 is administered to humans, so information about its safety remains limited. However, similar treatments targeting the TROP2 protein have been studied before.
In these studies, ASP2998 is used alone and with standard cancer treatments like pembrolizumab, carboplatin, and enfortumab vedotin. Trials with similar medicines have reported no treatment-related deaths, suggesting that ASP2998 might have a safety profile similar to other TROP2-targeting treatments.
As an early-stage study (Phase 1 and Phase 2), the focus is primarily on safety and determining the right dose. Researchers are assessing how well participants tolerate the treatment and monitoring for any serious side effects. Safety checks occur at every visit to closely monitor any medical issues.
Prospective participants should know that while early results may appear promising, the complete safety profile of ASP2998 is still under study.12345Why are researchers excited about this trial's treatments?
ASP2998 is unique because it offers a fresh approach to treating cancer by potentially targeting specific tumor types with precision. Most current treatments, like chemotherapy, attack both cancerous and healthy cells, leading to significant side effects. Researchers are excited about ASP2998 because it may provide a more targeted attack on cancer cells, which could mean fewer side effects and improved effectiveness. Additionally, ASP2998 is being tested in various combinations and dosage levels, which might optimize its impact across different cancer types, including urothelial carcinoma and non-small cell lung cancer. This adaptability and focus on precision make ASP2998 a promising candidate in cancer treatment innovation.
What evidence suggests that ASP2998 could be an effective treatment for solid tumors?
Research shows that ASP2998 targets a protein called TROP2, often found in tumors. By attaching to TROP2, ASP2998 aims to attack cancer cells, potentially slowing or stopping tumor growth. This trial tests ASP2998 both as a monotherapy and in combination with other standard cancer treatments. Although ASP2998 is being given to humans for the first time, targeting TROP2 in tumors has shown promise in other studies. Early results suggest that targeting this protein can interfere with the tumor’s ability to grow and spread. While more data is needed, ASP2998's mechanism provides a strong reason to believe it could be effective against solid tumors.15678
Who Is on the Research Team?
Medical Monitor
Principal Investigator
Astellas Pharma Global Development, Inc.
Are You a Good Fit for This Trial?
Adults with advanced solid tumors that can't be removed by surgery or have spread, who've had cancer worsen after treatment or couldn't receive treatment. Eligible cancers include certain types of bladder, lung, stomach, and breast cancer. Not for those with cancer in the brain/spinal cord coverings, nervous system symptoms, or on immune-suppressing drugs.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Part 1: Dose Escalation
Participants receive lower to higher doses of ASP2998, either alone or with standard cancer treatments, to determine suitable doses for Part 2.
Part 2: Dose Expansion
Participants receive suitable doses of ASP2998 determined from Part 1, either alone or with standard cancer treatments, to evaluate cancer response.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ASP2998
- Carboplatin
- Enfortumab Vedotin
- Pembrolizumab
Trial Overview
ASP2998 is a new drug targeting TROP2 protein in tumor cells. It's tested alone or with standard treatments like pembrolizumab (immunotherapy), carboplatin (chemotherapy), and enfortumab vedotin (antibody-drug conjugate). The trial has two parts: finding safe doses and then testing these doses' effectiveness against different cancers.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Participants with select tumor types will receive ASP2998 in a 21-day cycle at dose level(s) based on emerging data.
Participants with select tumor types will receive ASP2998 in a 21-day cycle at dose level(s) based on emerging data.
Participants with UC or NSCLC will receive ASP2998 in a 21-day cycle with dose level(s) selected from dose escalation.
Participants with urothelial carcinoma (UC), NSCLC, gastric/GEJ cancer or breast cancer (HER2-negative) will receive sequential doses of ASP2998 in a 21-day cycle.
Participants with select tumor types will receive ASP2998 in a 21-day cycle at dose level(s) based on emerging data.
Participants with select tumor types will receive ASP2998 in a 21-day cycle at dose level(s) based on emerging data.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Astellas Pharma Global Development, Inc.
Lead Sponsor
Tadaaki Taniguchi
Astellas Pharma Global Development, Inc.
Chief Medical Officer
M.D., Ph.D.
Naoki Okamura
Astellas Pharma Global Development, Inc.
Chief Executive Officer
Not available
Citations
NCT07287995 | A Study of ASP2998 Given by Itself and ...
ASP2998 is being developed to attach to TROP2 and then attack the tumor cells in people with solid tumors. ASP2998 will either be given by itself, or given ...
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Numbers in red within each box represent the actual results for FY24 (FY3/25). In the chart, red bars represent actuals, and yellow bars ...
Sutro Biopharma Announces First Cohort of Patients ...
The Phase 1 open-label, multicenter trial is designed to evaluate the safety, pharmacokinetics, and preliminary anti-tumor activity of STRO-004 ...
Press Releases
Combination therapy showed promising initial efficacy with a median OS of 25.6 months and a preliminary manageable safety profile in ...
A Real-World Data Study to Evaluate Treatment Patterns ...
This study provides a contemporary multicenter assessment of real-world treatment patterns and outcomes among palliatively treated patients with UC in Germany.
A Study of ASP2998 Given by Itself and ...
The main aim of the study is to check the safety of ASP2998 when given by itself and given with the standard cancer treatments, and how well it is tolerated.
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facingourrisk.org
facingourrisk.org/research-clinical-trials/results/printable?cancer_type=breast&%3Bstudy_type=treatment&%3Bstage=stage%204&page=2Force Research Search Results | Printable
Specimen and Data Study for Ovarian Cancer Early Detection and Prevention ... A Study of ASP2998 Given by Itself and Given With Standard Therapies in ...
ASP 2998 - AdisInsight
ASP 2998 is being developed by Astellas Pharma for the treatment of solid tumours. The drug targets TACSTD2-protein (TROP2) and then attack ...
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