An Open-label Phase I Study of ASP4396 in Participants With Locally Advanced (Unresectable) or Metastatic Solid Tumor Malignancies With KRAS G12D Mutation

Study Identifier:
4396-CL-0101
CT.gov Identifier:
NCT06364696
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment Complete

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Study Summary

The main aims of the study are to check the safety of ASP4396, how well people cope with medical problems during the study (how well it is tolerated), and to find a suitable dose of ASP4396.

To evaluate the safety and efficacy of ASP4396 in patients with advanced solid tumors with KRAS G12D mutations

Tumor assessments will be performed at screening and repeated every 6 weeks (± 1 week) during treatment

During safety and tumor imaging follow-up, imaging will be performed every 9 weeks (± 1 week) from the last on-treatment scan for up to 45 weeks until patients have disease progression per RECIST v1.1, initiate a new subsequent anticancer treatment, die, withdraw consent, or are lost to follow-up, whichever occurs first Dose-limiting toxicities will be summarized by dose level and evaluated during the first 21 days at each dose level

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Solid Tumor
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Experimental: ASP4396 Dose Escalation
    • Read More
  • Drug: Experimental: ASP4396 Dose Expansion
  • Drug: Drug: ASP4396
  • Drug: This study will be in 2 parts.
  • Drug: Part 1 is called Dose Escalation. Different small groups of people will receive lower to higher doses of ASP4396. For each dose, all medical problems will be recorded. The first group will receive the lowest dose of ASP4396. A medical expert panel will check the results and decide if the next group can receive a higher dose of Aart 1 is called Dose Escalation. Different small groups of people will receive lower to higher doses of ASP4396. For each dose, all medical problems will be recorded. The first group will receive the lowest dose of ASP4396. A medical expert panel will check the results and decide if the next group can receive a higher dose of ASP4396. The panel will do this until all groups have taken ASP4396 or until suitable doses have been selected for Part 2.
  • Drug: Part 2 is called Dose Expansion. Other different small groups of people will receive ASP4396 with the most suitable doses worked out from Part 1. This will help find a more accurate dose of ASP4396 to use in future studies.
  • Drug: In both parts of the study, ASP4396 will be given through a vein. This is called an infusion. Each treatment cycle is 21 days long. People will continue treatment until: they have medical problems from the treatment they can't cope with (can't tolerate); their cancer gets worse; they start other cancer treatment; or they ask to stop treatment.
  • Drug: People will visit the clinic on certain days during their treatment, with extra visits during the first 2 cycles of treatment. The study doctors will check for any medical problems from ASP4396. Also, people in the study will have a health check including blood tests. On some visits they will also have scans to check for any changes in their cancer. Tumor samples will be taken at certain visits during treatment with the option of a tumor sample being taken after treatment has finished.
  • Drug: People will visit the clinic about 7 days after they stop treatment. They will be asked about any medical problems and will have a health check including blood tests.
  • Drug: After this, people will visit the clinic for a health check several times. The number of visits and checks done at each visit will depend on the health of each person and whether they completed their treatment or not.
  • Drug: After treatment has finished, people in the study will be followed up for up to 45 weeks.
  • Drug: ASCO 2025:
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment Complete

    Requirements information
    Inclusion criteria
    • - Participant has locally advanced (unresectable) or metastatic solid tumor malignancy
    • with documented KRAS G12D mutation and has received prior standard therapy.
    • - Participant has at least 1 measurable lesion per RECIST v1.1.
    • - Participant has an ECOG performance status of 0 or 1.
    • - Participant has adequate organ function.
    • Patient's disease has progressed, or patient is intolerant, has refused, or has no available standard therapies (no limit to number of prior treatment regimens)
    • Adequate hematological, renal, and hepatic functions No prior treatment targeting KRAS G12D
    Exclusion criteria
    • - Participant has symptomatic or untreated central nervous system (CNS) metastases.
    • Participants with asymptomatic and treated and stable CNS metastases are eligible.
    • - Participant has leptomeningeal disease as a manifestation of the current malignancy.
    • - Participant has another prior malignancy active (i.e., requiring treatment or
    • intervention) within the previous 2 years different from the primary malignancy for
    • this study, except for local malignancies that have been apparently cured, such as
    • basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of
    • the cervix or breast, which are allowed.
    • - Participant with active hepatitis B or hepatitis C virus (HCV).
    • - Participant has a known history of human immunodeficiency virus (HIV) infection with
    • acquired immunodeficiency syndrome (AIDS)-related complications.
    • - Participant has an active infection requiring intravenous antibiotics within 14 days
    • prior to study intervention.
    • - Participant is expected to require another form of anticancer therapy while on study
    • intervention.
    • - Participant has any condition that makes the participant unsuitable for study
    • participation.
    • Patients who received prior treatment targeting KRAS G12D will be excluded.

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Midwest
    Grand Rapids, MI, United States, 49546
    Investigator
    Nehal Lakhani
    Status
    Recruiting
    Condition(s) Treated at Site
    Solid Tumor
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    William McKean
    Status
    Recruitment on Hold
    Condition(s) Treated at Site
    Solid Tumor