A Study of ASP1002 in Adults for Treatment of Solid Tumors

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Astellas Pharma Global Development, Inc.
Study ID
NCT05719558
Phase
PHASE1
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ASP1002 — DRUG
    intravenous (IV) infusion

Study Details

The main aims of this study are: * To check the safety of ASP1002 in people with certain solid tumors. * To check if the people can tolerate ASP1002. * To find a suitable dose of ASP1002. This study will be in 2 parts. In Part 1, different small groups of people will receive lower to higher doses of ASP1002. Any medical problems will be recorded at each dose. This is done to find suitable doses of ASP1002 to use in Part 2 of the study. In Part 2, other different small groups of people will receive doses of ASP1002 that worked the best in Part 1. People in this study will be adults with metastatic or locally advanced solid tumors with high levels of a protein called claudin 4. The people's cancer will have either spread to other parts of the body (metastatic) or spread to tissue close by (locally advanced). They will have been previously treated with available standard therapies or refused to receive those treatments. In both parts of the study, ASP1002 (the study treatment) will be given to people slowly through a tube into a vein. This is called an infusion. This will happen every week, every other week, or every 3 weeks, in treatment cycles. Treatment cycles may be 21 days or 28 days long. People in this study will continue treatment for up to 2 years until: they have medical problems that prevent them from continuing treatment; their cancer gets worse; they start other cancer treatment; they ask to stop treatment; they do not come back for treatment. During the study, people will visit the clinic several times for a health check. This includes standard safety checks and reporting any medical problems. Every few weeks, the study doctors will check if each person's cancer has stayed the same or got worse. This will be done by scans (CT or MRI scans). Tumor samples will be taken during the study and people will have the option of giving a tumor sample after treatment has finished. People will visit the clinic within 7 days after stopping treatment for a health check. Then, they may visit the clinic at 1 month and 3 months after stopping treatment for further health checks. People will have follow-up health checks for up to 1 year after their last dose of ASP1002.

Key Dates

Start date
Mar 13, 2023
Status verified
Mar 2026
Primary completion
Apr 30, 2028
Completion
May 31, 2028

Study Design

Enrollment
210 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ASP1002 Dose Escalation (Part 1)
    Participants will be assigned to sequentially escalating doses of ASP1002. Each dose level will open sequentially based upon sponsor review of emerging data.
  • Experimental: ASP1002 Dose Expansion (Part 2) non-small cell lung cancer (NSCLC)
    Participants will receive ASP1002 with dose/regimen selected from dose escalation (Part 1).
  • Experimental: Experimental: AS1002 Dose Expansion (Part 2) urothelial carcinoma (UC)
    Participants will receive ASP1002 with dose/regimen selected from dose escalation (Part 1).
  • Experimental: Experimental: ASP1002 Dose Expansion (Part 2) colorectal cancer (CRC)
    Participants will receive ASP1002 with dose/regimen selected from dose escalation (Part 1).

Primary Outcome Measure

Incidence of Dose Limiting Toxicities (DLTs) for ASP1002 [ Time Frame: Up to 24 months ]

Central Contacts

Locations (15)

FacilityCityStateZIPSite coordinators
Yale University Cancer CenterNew HavenConnecticut06520-
Hartford HealthCare Cancer Institute at The Hospital of Central ConnecticutPlainvilleConnecticut06062-
University of FloridaGainesvilleFlorida32610-
University of Iowa HospitalsIowa CityIowa52242-
Norton Cancer InstituteLouisvilleKentucky40202-
Henry Ford HospitalDetroitMichigan48202-
HealthPartners Cancer Research CenterSaint PaulMinnesota55101-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-
University Hospitals of ClevelandClevelandOhio44106-
Prisma Health-Upstate Cancer InstituteGreenvilleSouth Carolina29605-
SCRI Oncology PartnersNashvilleTennessee37203-
Mary Crowley Cancer Research CenterDallasTexas75251-
University of Texas SouthwesternDallasTexas75235-
NEXT Oncology VirginiaFairfaxVirginia22031-
Swedish Cancer InstituteEdmondsWashington21632-

Find similar trials in New Haven, CT

By research site
Yale University Cancer Center· New Haven, CTHartford HealthCare Cancer Institute at The Hospital of Central Connecticut· Plainville, CTUniversity of Florida· Gainesville, FLUniversity of Iowa Hospitals· Iowa City, IANorton Cancer Institute· Louisville, KYHenry Ford Hospital· Detroit, MI

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