TEAD Inhibitor for Solid Cancers

Recruiting in Palo Alto (17 mi)

+18 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Ikena Oncology

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion 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.

Signed informed consent must be obtained prior to participation in the study

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Exclusion Criteria

Other inclusion/exclusion criteria may apply

I am not pregnant or breastfeeding.

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

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Treatment Details

Interventions

IK-930 (TEAD Inhibitor)

Trial OverviewIK-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.

Participant Groups

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