Clinical Trials

Multiple clinical trials evaluate AMG 232 (KRT-232) across Phase 1, Phase 2, and Phase 3 studies as both monotherapy and combination regimens for diverse oncologic conditions, including acute myeloid leukemia, glioblastoma, soft tissue sarcoma, melanoma, multiple myeloma, small-cell lung cancer, and polycythemia vera. Sponsored by organizations such as Kartos Therapeutics, Inc., the National Cancer Institute, and Telios Pharma, Inc., these studies exhibit recruitment statuses ranging from active and recruiting to completed, terminated, or unknown. Early-phase investigations specifically assess the agent in advanced malignancies and refractory hematologic cancers.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03041688 ACTIVE_NOT_RECRUITING
Acute Myeloid Leukemia; Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia
National Cancer Institute (NCI)
 2018-02-08 PHASE1
NCT04190550 ACTIVE_NOT_RECRUITING
Acute Myeloid Leukemia; Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
National Cancer Institute (NCI)
 2021-02-04 PHASE1
NCT03107780 TERMINATED
Glioblastoma; Gliosarcoma; MGMT-Unmethylated Glioblastoma; Recurrent Glioblastoma
National Cancer Institute (NCI)
 2018-07-09 PHASE1
NCT04835584 UNKNOWN
Chronic Myeloid Leukemia
Kartos Therapeutics, Inc.
 2021-05-07 PHASE1; PHASE2
NCT03787602 UNKNOWN
Merkel Cell Carcinoma
Kartos Therapeutics, Inc.
 2019-03-19 PHASE1; PHASE2
NCT04669067 UNKNOWN
Acute Myeloid Leukemia
Telios Pharma, Inc.
 2021-03-31 PHASE1; PHASE2
NCT03031730 TERMINATED
Plasmacytoma; Recurrent Multiple Myeloma; Refractory Multiple Myeloma
National Cancer Institute (NCI)
 2018-06-14 PHASE1
NCT04878003 UNKNOWN
Primary Myelofibrosis (PMF); Post-Polycythemia Vera Myelofibrosis (Post-PV-MF); Post-Essential Thrombocythemia Myelofibrosis (Post-ET-MF)
Kartos Therapeutics, Inc.
 2021-04-13 PHASE2
NCT03662126 UNKNOWN
Primary Myelofibrosis (PMF); Post-Polycythemia Vera MF (Post-PV-MF); Post-Essential Thrombocythemia MF (Post-ET-MF)
Kartos Therapeutics, Inc.
 2019-01-15 PHASE2; PHASE3
NCT04113616 TERMINATED
Relapsed or Refractory Acute Myeloid Leukemia (AML); Acute Myeloid Leukemia (AML), Secondary to Myeloproliferative Neoplasms (MPN)
Kartos Therapeutics, Inc.
 2019-09-25 PHASE1; PHASE2
NCT03217266 COMPLETED
Resectable Soft Tissue Sarcoma; Soft Tissue Sarcoma
National Cancer Institute (NCI)
 2018-06-20 PHASE1
NCT04485260 UNKNOWN
Myelofibrosis
Kartos Therapeutics, Inc.
 2021-01-28 PHASE1; PHASE2
NCT04502394 RECRUITING
Diffuse Large B Cell Lymphoma; Chronic Lymphocytic Leukemia; Non Hodgkin Lymphoma
Kartos Therapeutics, Inc.
 2021-02-23 PHASE1; PHASE2
NCT05027867 TERMINATED
Small-cell Lung Cancer; Small Cell Lung Carcinoma; Small Cell Lung Cancer Extensive Stage; Small Cell Lung Cancer Recurrent
Kartos Therapeutics, Inc.
 2021-12-06 PHASE2
NCT04640532 UNKNOWN
Myelofibrosis; Post-PV MF; Post-ET Myelofibrosis; Primary Myelofibrosis
Kartos Therapeutics, Inc.
 2020-11-17 PHASE1; PHASE2
NCT03669965 ACTIVE_NOT_RECRUITING
Polycythemia Vera
Kartos Therapeutics, Inc.
 2019-01-15 PHASE2
NCT02110355 COMPLETED
Advanced Malignancy; Advanced Solid Tumors; Cancer; Oncology; Oncology Patients; Tumors; Melanoma
Kartos Therapeutics, Inc.
 2014-12-19 PHASE1
NCT02016729 COMPLETED
Advanced Malignancy; Cancer; Oncology; Oncology Patients; Acute Myeloid Leukemia
Kartos Therapeutics, Inc.
 2014-04-01 PHASE1
NCT01723020 COMPLETED
Advanced Malignancy; Advanced Solid Tumors; Cancer; Oncology; Oncology Patients; Tumors; Glioblastoma; Multiple Myeloma
Kartos Therapeutics, Inc.
 2012-12-27 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-06-11)

Check the AMG 232 ( KRT-232 ) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

AMG 232 functions as a potent, selective inhibitor of the MDM2–p53 interaction by binding directly to MDM2, thereby preventing MDM2-mediated degradation of p53 and restoring p53 transcriptional activity to induce cell-cycle arrest and apoptosis in p53 wild-type tumor cells. This targeted reactivation of the p53 tumor suppressor pathway provides the mechanistic rationale for evaluating AMG 232 in clinical trials against malignancies such as acute myeloid leukemia, glioblastoma, and soft tissue sarcomas.

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.