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MEK/RAF molecular glue

IK-595 for 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
Must not have
Patients with clinically significant cardiovascular disease
Patients with uncontrolled or life-threatening symptomatic concomitant diseases
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 1 year
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a serious heart condition.
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I do not have any severe illnesses that are not under control.
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I have recovered from side effects of previous cancer treatments to my normal health level or mild symptoms.
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I do not have active brain tumors or cancer spread to the lining of my brain.
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I cannot swallow or keep down oral medication.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Dose Limiting Toxicities
Recommended Phase 2 Dose (RP2D) and/or maximum tolerated dose (MTD) of IK-595
Treatment-Emergent Adverse Events
+1 more
Secondary study objectives
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 study objectives
Antitumor activity: Median overall survival (OS) of IK-595 as a single agent

Awards & Highlights

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

Trial Design

1Treatment groups
Experimental Treatment
Group I: IK-595Experimental Treatment1 Intervention
Dose Escalation and Dose Expansion

Find a Location

Who is running the clinical trial?

Ikena OncologyLead Sponsor
5 Previous Clinical Trials
489 Total Patients Enrolled
Trupti LingarajStudy DirectorIkena Oncology
Caroline Germa, MDStudy ChairIkena Oncology
2 Previous Clinical Trials
348 Total Patients Enrolled
~100 spots leftby Jul 2027
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