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MEK/RAF molecular glue

IK-595 for Pancreatic Cancer

Phase 1

Recruiting

Research Sponsored by Ikena Oncology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must be ≥ 18 years of age

Patients must have adequate organ function including ANC ≥ 1000/μL, Hemoglobin > 9 g/dL, Platelet count > 75,000/μL, Calculated creatinine clearance ≥ 60 mL/min, Serum total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN, AST and ALT ≤ 2.5 × ULN, Coagulation ≤ 1.5 × ULN, Left ventricular ejection fraction ≥ 50%, and must have recovered from the side effects of prior cancer-specific therapy to a minimum of ≥ Grade 1 by NCI-CTCAE version 5.0 criteria or return to baseline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 1 year

Awards & highlights

Study Summary

This trial aims to test the safety and effectiveness of a new drug called IK-595 in patients with advanced solid tumors that have specific genetic mutations. The study will investigate how well the drug works, its

Who is the study for?

This trial is for adults with advanced solid tumors that have specific gene changes in the RAS-MAPK pathway, such as certain types of cancer including thyroid, melanoma, pancreatic, lung, brain and colorectal cancers. Participants must have no remaining treatment options known to help them.Check my eligibility

What is being tested?

The study tests IK-595 taken orally. It's a Phase 1 trial aiming to find out how safe it is and how well people can tolerate it. The drug's effects on the body (pharmacokinetics) and tumor response are also being studied.See study design

What are the potential side effects?

As this is an early-phase trial for IK-595, detailed side effects aren't fully known yet. Common risks may include nausea, fatigue, skin rash or other reactions related to targeting the RAS-MAPK pathway.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My blood counts and organ functions are within normal ranges, and I have recovered from previous cancer treatments.

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I have an advanced cancer that cannot be surgically removed and no other treatments are expected to help.

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I am fully active or restricted in physically strenuous activity but can do light work.

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I agree to provide tissue samples for research.

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My cancer is advanced, cannot be surgically removed, has no other treatment options, and has RAS/RAF gene changes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Dose Limiting Toxicities

Recommended Phase 2 Dose (RP2D) and/or maximum tolerated dose (MTD) of IK-595

Treatment-Emergent Adverse Events

+1 more

Secondary outcome measures

Antitumor activity per RECIST 1.1: Disease control rate (DCR) of IK-595 as a single agent

Antitumor activity per RECIST 1.1: Duration of response (DOR) of IK-595 as a single agent

Antitumor activity per RECIST 1.1: Objective response rate (ORR) of IK-595 as a single agent

+7 more

Other outcome measures

Antitumor activity: Median overall survival (OS) of IK-595 as a single agent

Trial Design

1Treatment groups

Experimental Treatment

Group I: IK-595Experimental Treatment1 Intervention

Dose Escalation and Dose Expansion

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

Ikena OncologyLead Sponsor

5 Previous Clinical Trials

489 Total Patients Enrolled

Trupti LingarajStudy DirectorIkena Oncology

Sergio Santillana, MD, MScStudy ChairIkena Oncology

1 Previous Clinical Trials

198 Total Patients Enrolled

Frequently Asked Questions

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

What is the total number of participants involved in this clinical research study?

"A total of 150 eligible individuals are needed to enroll in this research study. Potential participants have the option to join at various centers such as Next Oncology- Virginia Cancer Specialists located in Fairfax, VA and University of Pittsburgh Medical Center- Hillman Cancer Center situated in Pittsburgh, PA."

Answered by AI

Are there still available openings for new participants in this research study?

"Affirmative. Records on clinicaltrials.gov indicate that this investigation is actively seeking participants. Initially listed on December 18th, 2023, the trial was last modified on February 13th, 2024. A total of 150 individuals are sought from five distinct sites."

Answered by AI

What is the level of risk associated with IK-595 for individuals?

"Based on the preliminary findings from this Phase 1 trial, IK-595 has received a safety rating of 1."

Answered by AI

In how many diverse venues is this experimental examination currently being conducted?

"Patient recruitment is ongoing at various esteemed institutions such as Next Oncology- Virginia Cancer Specialists in Fairfax, VA, University of Pittsburgh Medical Center- Hillman Cancer Center in Pittsburgh, PA, and Sarah Cannon Research Institute in Nashville, TN along with 5 additional sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of IK-595 in RAS- or RAF-altered Advanced Tumors

2023. "Study of IK-595 in RAS- or RAF-altered Advanced Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06270082.

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