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Monoclonal Antibodies

ASP4396 for Solid Tumors

Phase 1
Recruiting
Research Sponsored by Astellas Pharma Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participant has an ECOG performance status of 0 or 1
Participant has locally advanced (unresectable) or metastatic solid tumor malignancy with documented KRAS G12D mutation and has received prior standard therapy
Must not have
Participant with active hepatitis B or hepatitis C virus (HCV)
Participant has leptomeningeal disease as a manifestation of the current malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new potential treatment, ASP4396, for solid tumors in people with a specific gene mutation called G12D in the KRAS gene. The study will determine the safety,

Who is the study for?
Adults with advanced solid tumors that can't be removed by surgery or have spread to other body parts, and who have a specific gene change (KRAS G12D mutation). They should have tried standard treatments or declined them, be able to do daily activities with little help (ECOG status 0-1), and their organs must work well.
What is being tested?
ASP4396 is being tested for the first time in humans as a potential treatment for certain solid tumors. The study has two parts: finding a safe dose range (Dose Escalation) and confirming the best doses (Dose Expansion). Participants will receive ASP4396 through an infusion every three weeks until they experience significant side effects, cancer progression, start another treatment, or choose to stop.
What are the potential side effects?
Since this is the first trial of ASP4396 in humans, specific side effects are unknown but may include reactions related to infusions such as discomfort at injection site, allergic reactions; organ inflammation; fatigue; digestive issues; blood disorders. Close monitoring will identify any adverse effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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My cancer is advanced or has spread, has a KRAS G12D mutation, and I've had standard treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have active hepatitis B or C.
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My cancer has spread to the lining of my brain and spinal cord.
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I have HIV with AIDS-related complications.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 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 ASP4369
Number of Participants with Adverse Events (AEs)
Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status score
+5 more
Secondary study objectives
Change from baseline of Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D amino acid substitution (G12D) tumor samples
Disease Control Rate (DCR) per RECIST v 1.1
Duration of Response (DOR) per RECIST v 1.1
+13 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: ASP4396 Dose ExpansionExperimental Treatment1 Intervention
Participants will receive ASP4396 in a 21-day cycle.
Group II: ASP4396 Dose EscalationExperimental Treatment1 Intervention
Participants will receive ASP4396 in a 21-day cycle.

Find a Location

Who is running the clinical trial?

Astellas Pharma IncLead Sponsor
695 Previous Clinical Trials
233,133 Total Patients Enrolled
Central ContactStudy DirectorAstellas Pharma Inc
99 Previous Clinical Trials
6,397,328 Total Patients Enrolled
~117 spots leftby Apr 2027
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