Clinical Trials

Multiple clinical trials are evaluating PHI-101 in Phase 1 open-label studies sponsored by Seoul National University Hospital, with recruitment statuses currently listed as unknown. A clinical trial investigates the safety, tolerability, and pharmacokinetic profile of PHI-101 in patients diagnosed with platinum-resistant or refractory ovarian, fallopian tube, or primary peritoneal carcinomas. Meanwhile, a clinical trial evaluates the compound's safety, pharmacokinetics, and pharmacodynamics in individuals with relapsed or refractory acute myeloid leukemia.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04678102 UNKNOWN
Platinum-resistant Ovarian Cancer; Platinum-refractory Ovarian Carcinoma; Platinum-Resistant Fallopian Tube Carcinoma; Platinum-Resistant Primary Peritoneal Carcinoma
Seoul National University Hospital
 2020-12-17 PHASE1
NCT04842370 UNKNOWN
Relapsed or Refractory Acute Myeloid Leukemia
Seoul National University Hospital
 2020-06-08 PHASE1

(data from https://clinicaltrials.gov, updated on 2023-06-26)

Check the PHI-101 product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

PHI-101 selectively binds to and inhibits FMS-like tyrosine kinase 3 (FLT3), blocking downstream oncogenic signaling cascades and thereby suppressing cellular proliferation while inducing apoptosis in resistant malignant cells. This target-directed inhibition of drug-resistant kinase variants provides a rationale for investigating PHI-101 in relapsed or refractory acute myeloid leukemia and advanced platinum-resistant gynecologic cancers.

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>).

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