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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

Study Summary

This trial studies a new treatment (ASP1002) for people with certain solid tumors. It aims to learn if it has any medical problems or side effects and to find a suitable dose to use in future studies. People will receive infusions & checks during visits over 2 years.

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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
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

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.

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.

Find a Location

Who is running the clinical trial?

Astellas Pharma Global Development, Inc.Lead Sponsor
197 Previous Clinical Trials
121,926 Total Patients Enrolled
Medical DirectorStudy DirectorAstellas Pharma Global Development, Inc.
2,800 Previous Clinical Trials
8,069,990 Total Patients Enrolled

Media Library

ASP1002 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05719558 — Phase 1
Solid Tumors Research Study Groups: Experimental: AS1002 Dose Expansion (Part 2) urothelial carcinoma (UC), Experimental: ASP1002 Dose Expansion (Part 2) colorectal cancer (CRC), ASP1002 Dose Escalation (Part 1), ASP1002 Dose Expansion (Part 2) non-small cell lung cancer (NSCLC)
Solid Tumors Clinical Trial 2023: ASP1002 Highlights & Side Effects. Trial Name: NCT05719558 — Phase 1
ASP1002 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05719558 — Phase 1
~140 spots leftby Apr 2028