← Back to Search

Monoclonal Antibodies

ASP4396 Dose Expansion 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I am fully active or can carry out light work.

Select...

My cancer is advanced or has spread, has a KRAS G12D mutation, and I've had standard treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months

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

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 ASP4369

Number of Participants with Adverse Events (AEs)

Number of Participants with Eastern Cooperative Oncology Group (ECOG) performance status score

+5 more

Secondary outcome measures

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

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Astellas Pharma IncLead Sponsor

692 Previous Clinical Trials

232,063 Total Patients Enrolled

Central ContactStudy DirectorAstellas Pharma Inc

98 Previous Clinical Trials

6,397,187 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial currently seeking and enrolling participants?

"Indeed, information on clinicaltrials.gov indicates that this investigation is actively seeking volunteers. The trial was initially shared on April 16th, 2024 and last revised on April 26th, 2024. It aims to recruit a total of 175 participants distributed across four distinct sites."

Answered by AI

What is the current number of individuals who are being enrolled in this medical study?

"Affirmative. Details on clinicaltrials.gov indicate that this medical trial is actively seeking candidates. It was first listed on 4/16/2024 and last revised on 4/26/2024. The study aims to enroll a total of 175 individuals across four specified sites."

Answered by AI

What is the risk level associated with ASP4396 Dose Expansion in individuals?

"The safety rating for ASP4396 Dose Expansion is marked as 1 by our experts at Power. This low score reflects the preliminary nature of this Phase 1 trial with minimal data supporting both safety and efficacy."

Answered by AI

What is the primary objective of this medical study?

"The key focus of this medical investigation, spanning around Up to 12 months, is the identification of Participants with electrocardiogram (ECG) anomalies and/or Adverse Events. Supplementary measures will include Disease Control Rate (DCR) following RECIST v1.1 guidelines - defined as participants achieving confirmed or unconfirmed Complete Response (CR), Partial Response (PR), or Stable Disease (SD). Moreover, there will be an analysis of ASP4396 plasma Pharmacokinetics: AUC168h captured from PK samples and ASP4396 plasma Pharmacokinetics: pre-dose concentration during repeat dosing cycles Ctrough obtained from"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors

2024. "A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06364696.

All > Paid Studies Baltimore > Fort Worth