Clinical Trials

Sponsored by Ikena Oncology, multiple clinical trials are evaluating IK-930 in adult patients with advanced solid tumors, including malignant pleural mesothelioma, epithelioid hemangioendothelioma, and malignancies characterized by NF2 deficiency or YAP1/TAZ gene fusions. These Phase 1 studies encompass recruitment statuses ranging from active recruitment to study termination. Overall, these investigations aim to characterize the safety, tolerability, and therapeutic efficacy of targeting Hippo pathway-altered solid tumors.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05228015 TERMINATED
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
Ikena Oncology
2022-01-07 PHASE1
NCT05228015 Recruiting
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
Ikena Oncology
2022-01-07 Phase 1

(data from https://clinicaltrials.gov, updated on 2024-11-18)

Check the IK-930 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

IK-930 is a selective small-molecule inhibitor that binds transcriptional enhancer associate domain (TEAD) transcription factors to prevent palmitate binding, thereby disrupting downstream aberrant TEAD-dependent gene transcription and suppressing tumor cell proliferation. This blockade of oncogenic transcriptional activity halts Hippo pathway signaling, providing the mechanistic basis for inhibiting tumor growth in clinical trial conditions such as malignant pleural mesothelioma, epithelioid hemangioendothelioma, and NF2-deficient solid tumors.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

Note: Technical data last updated: Sep 1, 2026.