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Oral TEAD Inhibitor Targeting the Hippo Pathway in Subjects with Advanced Solid Tumors

NCT05228015 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2024-11-18

No results posted yet for this study

Summary

This is a Phase 1, first-in-human (FIH) clinical study to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of IK-930, an oral TEAD inhibitor, administered orally (PO) as monotherapy in subjects with advanced solid tumors with or without gene alterations in the Hippo pathway for whom there are no further treatment options known to confer clinical benefit. The study consists of two phases, an initial Dose Escalation phase followed by a Dose Expansion phase.

Conditions

  • Solid Tumors, Adult
  • Solid Tumor
  • Malignant Pleural Mesothelioma (MPM)
  • Epithelioid Hemangioendothelioma (EHE)
  • NF2 Deficient Mesothelioma
  • Other NF2 Deficient Solid Tumors and Solid Tumors with YAP1/TAZ Fusion Genes
  • NF2 Deficiency
  • YAP1 or TAZ Gene Fusions

Interventions

DRUG

IK-930

tablets for oral administration

DRUG

Osimertinib

tablets for oral administration

Sponsors & Collaborators

  • Ikena Oncology

    lead INDUSTRY

Principal Investigators

  • Katherine Kim, MD · Ikena Oncology

  • Caroline Germa, MD · Ikena Oncology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-07
Primary Completion
2024-08-27
Completion
2024-09-09
FDA Drug
Yes

Countries

  • United States
  • Australia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05228015 on ClinicalTrials.gov