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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Ikena Oncology
Study ID
NCT05228015
Phase
PHASE1
Status
Terminated

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IK-930 — DRUG
    tablets for oral administration
  • Osimertinib — DRUG
    tablets for oral administration

Study Details

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.

Key Dates

Start date
Jan 7, 2022
Status verified
Nov 2024
Primary completion
Aug 27, 2024
Completion
Sep 9, 2024

Study Design

Enrollment
67 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: IK-930 Single Agent Dose Escalation
  • Experimental: IK-930 Single Agent Dose Expansion
  • Experimental: IK-930 and Osimertinib Combination Dose Escalation

Primary Outcome Measure

Safety and tolerability of IK-930 [ Time Frame: Through study completion, an average of 36 months ]

Locations (9)

FacilityCityStateZIPSite coordinators
The University of ChicagoChicagoIllinois60637-
Massachusetts General HospitalBostonMassachusetts02215-
Start MidwestGrand RapidsMichigan49546-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Sidney Kimmel Cancer Center at Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
University of Pennsylvania Abramson Cancer CenterPhiladelphiaPennsylvania19104-
Sarah Cannon Research InstituteNashvilleTennessee37203-
MD Anderson Cancer CenterHoustonTexas77030-
Next OncologySan AntonioTexas78229-

Find similar trials in Chicago, IL

By research site
The University of Chicago· Chicago, ILMassachusetts General Hospital· Boston, MAStart Midwest· Grand Rapids, MIMemorial Sloan Kettering Cancer Center· New York, NYSidney Kimmel Cancer Center at Thomas Jefferson University Hospital· Philadelphia, PAUniversity of Pennsylvania Abramson Cancer Center· Philadelphia, PA

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