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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 1 year
Awards & highlights
Study Summary
This trial is testing a new drug to see if it's safe and effective against solid tumors. The study will first test increasing doses of the drug to see what effects it has, then expand to a larger group of people.
Who is the study for?
Adults with advanced solid tumors, including mesothelioma and neurofibromatosis type 2, who have no other treatment options. Participants must be able to take oral medication and consent to tumor tissue submission. Specific groups include those with NF2 deficiency or gene fusions in the Hippo pathway.Check my eligibility
What is being tested?
IK-930, an oral TEAD inhibitor targeting the Hippo pathway, is being tested for safety and effectiveness in two phases: Dose Escalation to find a safe dosage level followed by Dose Expansion to further assess its impact on various advanced solid tumors.See study design
What are the potential side effects?
While specific side effects of IK-930 are not listed here as it's first-in-human use, potential risks may include typical drug reactions such as nausea, fatigue, allergic responses or more serious complications depending on how it affects the body.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Occurrence of Dose Limiting Toxicity during first treatment cycle
RP2D and/or MTD of IK-930
Safety and tolerability of IK-930
Secondary outcome measures
Antitumor activity per RECIST 1.1: Disease control rate (DCR) of IK-930 as a single agent
Antitumor activity per RECIST 1.1: Duration of response (DOR) of IK-930 as a single agent
Antitumor activity per RECIST 1.1: Objective response rate (ORR) of IK-930 as a single agent
+7 moreSide effects data
From 2023 Phase 3 trial • 29 Patients • NCT0245493347%
Diarrhoea
41%
Paronychia
41%
Dermatitis acneiform
29%
Stomatitis
29%
Arthralgia
24%
Viral upper respiratory tract infection
24%
Cough
24%
Neutropenia
24%
Dyspnoea
24%
Pruritus
18%
Rhinorrhoea
18%
Back pain
18%
Productive cough
18%
Nausea
18%
Upper respiratory tract infection
18%
Neutrophil count decreased
18%
Dry skin
18%
Constipation
18%
Pneumonia
12%
Lung infection
12%
Aspartate aminotransferase increased
12%
Electrocardiogram QT prolonged
12%
Musculoskeletal chest pain
12%
Vomiting
12%
Alanine aminotransferase increased
12%
Decreased appetite
12%
Dizziness
12%
Dysphonia
12%
Epistaxis
12%
Rash maculo-papular
6%
Orthostatic hypotension
6%
Fatigue
6%
Spontaneous haemorrhage
6%
Tinnitus
6%
Ear discomfort
6%
Hypoacusis
6%
Blepharitis
6%
Catheter site injury
6%
Gastroenteritis
6%
Blepharospasm
6%
Joint swelling
6%
Hypoaesthesia
6%
Sinus congestion
6%
Pain of skin
6%
Insomnia
6%
Complication associated with device
6%
Asthenia
6%
Hypertension
6%
Anxiety
6%
Anaemia
6%
Onychoclasis
6%
Headache
6%
Ocular hyperaemia
6%
Epigastric discomfort
6%
Gastritis
6%
Mouth ulceration
6%
Ligament sprain
6%
Muscle spasms
6%
Osteoarthritis
6%
Renal vein embolism
6%
Urinary incontinence
6%
Uterine mass
6%
Laryngeal haemorrhage
6%
Rash macular
6%
Organising pneumonia
6%
Hot flush
6%
Dry eye
6%
Eyelid pain
6%
Retinal drusen
6%
Abdominal pain
6%
Flatulence
6%
Oesophageal pain
6%
Toothache
6%
Pain
6%
Seasonal allergy
6%
Atypical pneumonia
6%
Cystitis
6%
Influenza
6%
Lower respiratory tract infection
6%
Oral candidiasis
6%
Sinusitis
6%
Avulsion fracture
6%
Fall
6%
Urine analysis abnormal
6%
Bone pain
6%
Musculoskeletal pain
6%
Osteoporosis
6%
Pain in extremity
6%
Amnesia
6%
Paraesthesia
6%
Vaginal haemorrhage
6%
Nasal congestion
6%
Pleural effusion
6%
Sneezing
6%
Eczema asteatotic
6%
Intertrigo
6%
Milia
6%
Palmar-plantar erythrodysaesthesia syndrome
6%
Pruritus generalised
6%
Rash
6%
Skin fissures
6%
Urticaria
6%
Xanthelasma
6%
Urinary tract infection
6%
Pyrexia
6%
Colorectal cancer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Osimertinib 80 mg
Osimertinib 80 mg + Durvalumab 10 mg/kg
Trial Design
3Treatment groups
Experimental Treatment
Group I: IK-930 and Osimertinib Combination Dose EscalationExperimental Treatment2 Interventions
Group II: IK-930 Single Agent Dose ExpansionExperimental Treatment1 Intervention
Group III: IK-930 Single Agent Dose EscalationExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Osimertinib
2017
Completed Phase 4
~1010
Find a Location
Who is running the clinical trial?
Ikena OncologyLead Sponsor
5 Previous Clinical Trials
441 Total Patients Enrolled
Caroline Germa, MDStudy ChairIkena Oncology
2 Previous Clinical Trials
300 Total Patients Enrolled
Katherine Kim, MDStudy DirectorIkena Oncology
1 Previous Clinical Trials
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to provide tissue samples from my tumor for the study.There are four groups of subjects that will be enrolled:
1. People with a confirmed type of cancer called malignant pleural mesothelioma and a specific genetic deficiency called NF2.
2. People with other types of solid tumors that also have the NF2 genetic deficiency.
3. People with a specific type of cancer called epithelioid hemangioendothelioma (EHE) and a specific gene fusion called TAZ-CAMTA1 or YAP1-TFE3.
4. People with any type of solid tumor that has a specific gene fusion called YAP1/TAZ.
People in all groups must have evidence of disease progression from prior treatment or active disease with cancer-related pain requiring strong pain medication. They must also have disease that can be measured or evaluated using specific criteria. Lastly, they must follow the study plan and agree to planned biopsy procedures.I am not pregnant or breastfeeding.I have a serious heart condition as described in the study details.I have advanced cancer with no standard treatment options left.I do not have untreated brain tumors or cancer that has spread to my brain.I cannot swallow or keep down oral medication.I am 18 years old or older.I do not have any severe illnesses that are not under control.
Research Study Groups:
This trial has the following groups:- Group 1: IK-930 Single Agent Dose Escalation
- Group 2: IK-930 Single Agent Dose Expansion
- Group 3: IK-930 and Osimertinib Combination Dose Escalation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide the quantity of facilities hosting this experimental program?
"At present, this clinical research is being conducted in 6 distinct medical centres. These are located in Grand Rapids, Nashville and Philadelphia amongst other cities. To reduce the burden of travel for participants it is important to select the site closest to you."
Answered by AI
What is the upper limit for participants in this experiment?
"Affirmative. According to information hosted on clinicaltrials.gov, this medical study - which was first published on July 1st 2022 - is actively recruiting participants. 158 individuals from 6 different healthcare facilities need to be enrolled in the trial."
Answered by AI
Has the FDA greenlit IK-930 for commercial release?
"As it is only a Phase 1 trial, the team at Power gave IK-930 an initial safety rating of 1 due to its lack of documented effectiveness and limited evidence regarding potential risks."
Answered by AI
Is there an open enrollment period for this research project?
"Affirmative. The information available on clinicaltrials.gov demonstrates that enrollment for this trial is still open; it was originally posted in July 2022 and was last amended in June of the same year. A total of 158 participants are needed from 6 different medical centres."
Answered by AI
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