What is the mechanism of action of this treatment?

Epithelioid Hemangioendothelioma (EHE) treatments often target specific molecular pathways involved in tumor growth and angiogenesis. TEAD inhibitors, like IK-930, focus on the Hippo pathway, which regulates cell proliferation and apoptosis. By inhibiting TEAD, these treatments aim to suppress tumor growth and induce cancer cell death. This targeted approach is significant for EHE patients as it directly interferes with the molecular mechanisms driving the disease, potentially improving treatment outcomes.

What side effects are associated with this type of intervention?

Common treatments for Epithelioid Hemangioendothelioma (EHE) include antiangiogenic therapies such as sunitinib and pazopanib. Known side effects of these treatments can include hypertension, hypothyroidism, diarrhea, fatigue, and hand-foot syndrome. Additionally, targeted therapies like the TEAD inhibitor IK-930, which are still under investigation, may have side effects such as liver impairment, renal issues, and gastrointestinal disturbances. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The provided context does not mention any specific FDA-approved treatments for Epithelioid Hemangioendothelioma (EHE). However, it does discuss the use of antiangiogenic therapies such as sunitinib and pazopanib, which target the vascular endothelial growth factor (VEGF) pathway. These treatments have shown some efficacy in managing EHE, although they are not directly related to the TEAD inhibitor IK-930 being studied in the trial.

What other types of research exist?

Promising novel alternatives to IK-930 for Epithelioid Hemangioendothelioma patients include: 1) Axitinib, a potent VEGFR inhibitor, which has shown activity in advanced thyroid cancer and could be relevant for EHE due to its anti-angiogenic properties. 2) Vandetanib, an inhibitor of VEGFR, EGFR, and RET, which has demonstrated efficacy in medullary thyroid cancer and may offer benefits for EHE. 3) Cabozantinib, a tyrosine kinase inhibitor targeting MET, VEGFR, and AXL, which has shown activity in medullary thyroid cancer and could be considered for EHE treatment.

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TEAD Inhibitor

TEAD Inhibitor for Solid Cancers

Phase 1

Waitlist Available

Research Sponsored by Ikena Oncology

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Must not have

Women who are pregnant or breastfeeding

Clinically significant cardiovascular disease as defined in the protocol

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximately 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing IK-930, a new oral medicine, in patients with advanced solid tumors who have no other effective treatments. The medicine aims to block a protein that helps cancer cells grow.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I have a serious heart condition as described in the study details.

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I cannot swallow or keep down oral medication.

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I do not have any severe illnesses that are not under control.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

RP2D and/or MTD of IK-930

Safety and tolerability of IK-930

Side effects data

From 2023 Phase 3 trial • 29 Patients • NCT02454933

47%

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%

Back pain

18%

Productive cough

18%

Rhinorrhoea

18%

Nausea

18%

Upper respiratory tract infection

18%

Neutrophil count decreased

18%

Dry skin

18%

Constipation

18%

Pneumonia

12%

Electrocardiogram QT prolonged

12%

Aspartate aminotransferase increased

12%

Vomiting

12%

Lung infection

12%

Musculoskeletal chest pain

12%

Alanine aminotransferase increased

12%

Decreased appetite

12%

Dizziness

12%

Dysphonia

12%

Epistaxis

12%

Rash maculo-papular

Osteoporosis

Colorectal cancer

Tinnitus

Flatulence

Epigastric discomfort

Hypertension

Orthostatic hypotension

Anaemia

Spontaneous haemorrhage

Ear discomfort

Blepharitis

Ocular hyperaemia

Hypoacusis

Blepharospasm

Mouth ulceration

Fatigue

Gastritis

Asthenia

Catheter site injury

Complication associated with device

Gastroenteritis

Ligament sprain

Joint swelling

Muscle spasms

Osteoarthritis

Headache

Hypoaesthesia

Anxiety

Insomnia

Renal vein embolism

Urinary incontinence

Milia

Uterine mass

Laryngeal haemorrhage

Organising pneumonia

Sinus congestion

Onychoclasis

Pain of skin

Pruritus generalised

Rash macular

Hot flush

Dry eye

Eyelid pain

Retinal drusen

Abdominal pain

Oesophageal pain

Toothache

Pain

Seasonal allergy

Atypical pneumonia

Cystitis

Influenza

Lower respiratory tract infection

Oral candidiasis

Sinusitis

Avulsion fracture

Fall

Urine analysis abnormal

Bone pain

Musculoskeletal pain

Pain in extremity

Amnesia

Paraesthesia

Vaginal haemorrhage

Nasal congestion

Pleural effusion

Sneezing

Eczema asteatotic

Intertrigo

Palmar-plantar erythrodysaesthesia syndrome

Rash

Skin fissures

Urticaria

Xanthelasma

Urinary tract infection

Pyrexia

100%

80%

60%

40%

20%

Study treatment Arm

Osimertinib 80 mg

Osimertinib 80 mg + Durvalumab 10 mg/kg

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~1100

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Epithelioid Hemangioendothelioma (EHE) treatments often target specific molecular pathways involved in tumor growth and angiogenesis. TEAD inhibitors, like IK-930, focus on the Hippo pathway, which regulates cell proliferation and apoptosis. By inhibiting TEAD, these treatments aim to suppress tumor growth and induce cancer cell death. This targeted approach is significant for EHE patients as it directly interferes with the molecular mechanisms driving the disease, potentially improving treatment outcomes.

Beyond EGFR Targeting in SCCHN: Angiogenesis, PI3K, and Other Molecular Targets.Anti-angiogenic therapy for high-grade glioma.Targeted Therapy of Ovarian Cancer with Angiogenesis Inhibitors.