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)
Mechanism and Biochemical Profile
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>).