What is the mechanism of action of this treatment?

Common treatments for solid tumors often involve targeted therapies that disrupt specific proteins or pathways essential for tumor growth and survival. For example, ASP1002 targets claudin 4, a protein overexpressed in certain solid tumors, aiming to inhibit tumor cell proliferation and induce cell death. This targeted approach is significant for solid tumor patients as it offers the potential for more precise and effective treatment options with fewer side effects compared to traditional chemotherapy, ultimately improving patient outcomes and quality of life.

What side effects are associated with this type of intervention?

Common side effects of treatments for solid tumors, particularly those targeting specific proteins like Claudin 4, include infusion-related reactions, fatigue, nausea, diarrhea, skin rash, and liver toxicity. Immunotherapies may also cause immune-related adverse events such as pneumonitis, colitis, hepatitis, endocrinopathies, and dermatologic reactions. These side effects are closely monitored in clinical trials to ensure patient safety and determine the optimal dosing.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for the treatment of solid tumors, focusing on specific proteins and pathways involved in cancer growth and progression. Examples include pembrolizumab and nivolumab, which target the PD-1/PD-L1 pathway, and bevacizumab, which inhibits angiogenesis by targeting VEGF. While specific FDA approvals for drugs targeting claudin 4 in solid tumors are not mentioned, the development of ASP1002 represents a similar approach, aiming to exploit specific protein expressions in tumors to improve treatment efficacy.

What other types of research exist?

Promising novel alternatives to ASP1002 for solid tumors include: 1) IMAB362 (anti-Claudin 18.2), which is in early clinical trials and shows encouraging results; 2) TAS-118 and TAS-102, which are also in early clinical trials; 3) STAT3 inhibitors; 4) immune checkpoint inhibitors such as pembrolizumab and atezolizumab, which have shown efficacy in various solid tumors. These alternatives are currently being evaluated in clinical trials and may offer new treatment options by 2024.

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ASP1002 for Cancer

Phase 1

Recruiting

Research Sponsored by Astellas Pharma Global Development, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 28 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing ASP1002, a new medicine for certain cancers. It focuses on adults with advanced tumors that haven't responded to other treatments. Researchers aim to understand how the body processes ASP1002 and its side effects, to find the best dose for future use.

Who is the study for?

Adults with advanced solid tumors and high claudin 4 levels, who've tried standard treatments or refused them, can join. They must be fairly active (ECOG Status of 0 or 1), expected to live at least 12 weeks, have good organ function, and a measurable tumor. Pregnant women can't join; participants must agree to contraception.

What is being tested?

ASP1002 is being tested in two parts: first to find safe doses by giving it through an IV in increasing amounts to small groups. Then the best doses are used on different groups for up to two years or until side effects become too severe.

What are the potential side effects?

Potential side effects include reactions related to infusion, fatigue, changes in blood tests reflecting organ functions, and possibly other symptoms that could lead participants to stop treatment if they become serious.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 28 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 28 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 28 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of Dose Limiting Toxicities (DLTs) for ASP1002

Number of participants at each grade of Eastern Cooperative Oncology Group (ECOG) performance status scores

Number of participants with Adverse Events (AEs)

+5 more

Secondary study objectives

Changes in expression levels of Claudin-4 (CLDN4) by immunohistochemistry (IHC)

Disease Control Rate (DCR) per RECIST v1.1

Disease Control Rate (DCR) per iRECIST

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Experimental: ASP1002 Dose Expansion (Part 2) colorectal cancer (CRC)Experimental Treatment1 Intervention

Participants will receive ASP1002 with dose/regimen selected from dose escalation (Part 1).

Group II: Experimental: AS1002 Dose Expansion (Part 2) urothelial carcinoma (UC)Experimental Treatment1 Intervention

Participants will receive ASP1002 with dose/regimen selected from dose escalation (Part 1).

Group III: ASP1002 Dose Expansion (Part 2) non-small cell lung cancer (NSCLC)Experimental Treatment1 Intervention

Participants will receive ASP1002 with dose/regimen selected from dose escalation (Part 1).

Group IV: ASP1002 Dose Escalation (Part 1)Experimental Treatment1 Intervention

Participants will be assigned to sequentially escalating doses of ASP1002. Each dose level will open sequentially based upon sponsor review of emerging data.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for solid tumors often involve targeted therapies that disrupt specific proteins or pathways essential for tumor growth and survival. For example, ASP1002 targets claudin 4, a protein overexpressed in certain solid tumors, aiming to inhibit tumor cell proliferation and induce cell death. This targeted approach is significant for solid tumor patients as it offers the potential for more precise and effective treatment options with fewer side effects compared to traditional chemotherapy, ultimately improving patient outcomes and quality of life.

Role of Claudin Proteins in Regulating Cancer Stem Cells and Chemoresistance-Potential Implication in Disease Prognosis and Therapy.Effects of claudin-1 downregulation on the physiological processes of gallbladder cancer SGC996 cells.