ASP388B for Solid Tumors
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new cancer treatment called ASP388B in individuals with certain solid tumors. Researchers will assess the safety of ASP388B and determine the optimal dose, whether administered alone or with standard cancer treatments. Participants with head and neck, esophageal, prostate, or lung cancers that have not responded well to other treatments might be suitable candidates. The study involves receiving the treatment through an infusion (a slow delivery into a vein) every three weeks, with ongoing monitoring for any medical issues. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
In a previous study, researchers did not test ASP388B on humans, so specific safety information is not yet available. This trial marks one of the first instances of testing ASP388B with people. The main goal is to assess its safety and determine the optimal treatment dose. As an early-stage trial, researchers will begin with low doses, gradually increasing them to identify the most suitable dose that patients can tolerate without serious side effects. Regular safety checks will monitor for any medical issues. This early study primarily focuses on understanding the treatment's effects on people and ensuring its safety.12345
Why are researchers excited about this trial's treatments?
Researchers are excited about ASP388B because it offers a new approach for treating various solid tumors, like head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC), and others. Unlike existing therapies that may involve chemotherapy or radiation, ASP388B targets specific molecular pathways unique to these cancer types, potentially offering more precise and effective treatment. This targeted action could lead to better outcomes with possibly fewer side effects compared to traditional treatments. Additionally, ASP388B can be used both as a monotherapy and in combination with other treatments, providing flexibility in its application to maximize patient benefits.
What evidence suggests that this trial's treatments could be effective for solid tumors?
ASP388B is a new treatment under investigation for solid tumors, including cancers of the head, neck, and esophagus. These cancers often present late and can be difficult to treat. The trial includes various treatment arms to evaluate ASP388B both as a monotherapy and in combination with other treatments. The aim is to target specific cancer cells, potentially slowing or stopping tumor growth. Although ASP388B remains in the early stages of testing, researchers are studying its safety and effectiveness across different arms to find the optimal dose and determine which tumor types respond well.678910
Who Is on the Research Team?
Medical Monitor
Principal Investigator
Astellas Pharma Global Development, Inc.
Are You a Good Fit for This Trial?
This trial is for adults with advanced or metastatic solid tumors (like small cell lung cancer, squamous cell carcinoma, esophageal cancer) who have tried all standard treatments or can't receive them. Participants must show their disease is getting worse and meet certain hormone levels if they have prostate cancer.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants receive ASP388B in escalating doses, either as monotherapy or in combination with standard cancer therapies, in 21-day cycles to determine suitable doses.
Treatment Part 2
Participants receive the most suitable doses of ASP388B determined from Part 1, either as monotherapy or in combination with standard cancer therapies, in 21-day cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of adverse events and laboratory abnormalities.
What Are the Treatments Tested in This Trial?
Interventions
- 5-fluorouracil
- ASP388B
- Carboplatin
- Oxaliplatin
- Pembrolizumab
Trial Overview
The study tests a new drug called ASP388B given alone or with standard chemotherapy drugs (Pembrolizumab, Carboplatin, Oxaliplatin, 5-fluorouracil). The main goal is to find the safest dose and check for side effects in people with different types of solid tumors.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Participants with HNSCC excluding NPC, will receive ASP388B in 21-day cycles with dose level(s) selected from dose escalation.
Participants with ESCC will receive ASP388B in 21-day cycles with dose level(s) selected from dose escalation.
Participants with head and neck squamous cell carcinoma (HNSCC) \[including nasopharyngeal cancer (NPC)\], esophageal squamous cell carcinoma (ESCC), metastatic castration-resistant prostate cancer(mCRPC), squamous non-small cell lung cancer (sqNSCLC) or small cell lung cancer (SCLC) will receive the dose based on the assigned dose level of ASP388B in 21-day cycles.
Participants with HNSCC excluding NPC and salivary gland tumors will receive ASP388B in 21-day cycles at dose level(s) based on emerging data.
Participants with ESCC will receive ASP388B in 21-day cycles at dose level(s) based on emerging data.
Participants with HNSCC excluding NPC and salivary gland tumors will receive ASP388B in 21-day cycles at dose level(s) based on emerging data.
Participants with ESCC will receive ASP388B in 21-day cycles 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
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These extra cells can form a mass called a tumor. Tumors can be benign or malignant. Benign tumors aren't cancer, while malignant ones are.
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