Trametinib + HDM201 in CRC Patients With RAS/RAF Mutant and TP53 Wild-type Advanced/Metastatic Colorectal Cancer Mutant and TP53 Wild-type (TRAHD)

  • STATUS
    Recruiting
  • participants needed
    24
  • sponsor
    Centre Leon Berard
Updated on 8 February 2023
platelet count
renal function
cancer
measurable disease
carcinoma
sargramostim
growth factor
investigational drug
x-rays
gilbert's syndrome
serum bilirubin
serum bilirubin level
BRAF
KRAS
TP53
major surgery
metastasis
progressive disease
neutrophil count
liver metastasis
metastatic colorectal cancer
g-csf
aptt
mek inhibitor
serum total bilirubin
granulocyte-macrophage colony-stimulating factor
renal function test
ki-ras

Summary

Recent preclinical studies suggest that combining MEK and MDM2 inhibition synergize to induce apoptosis in RAS/BRAF-mutant and TP53 wild-type CRC models. In vitro, in RKO cell lines (poorly differentiated colon carcinoma cell line resistant to single agent targeting MDM2 and MEK and BRAF inhibition), the MDM2 plus MEK inhibitor combination generated a synergistic increase in apoptotic index. In vivo, in mice harboring human RKO colon tumor xenografts the combination of MDM2 plus MEK inhibition elicited 93% decreases in tumor volume.

This trial is to conduct a single-center, Phase 1 dose escalation study of trametinib combined with HDM201 (a HDM2 inhibitor) in patients with advanced/metastatic RAS/RAF mutant and TP53 wt CRC.

Description

This trial is a Phase I dose escalation study aiming to evaluate the safety of a combined treatment associating HDM201 (escalating doses) with Trametinib (fixed dose). This study will utilize sequential and adaptive Bayesian design using the method of Time-to-event Continual Reassessment Method (CRM) to guide dose escalation and estimate the MTD.

Details
Condition Colorectal Cancer, Advanced Cancer, Metastatic Cancer
Treatment Trametinib, HDM201
Clinical Study IdentifierNCT03714958
SponsorCentre Leon Berard
Last Modified on8 February 2023

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