Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT06090318

Milademetan in Combination With Atezolizumab in Patients With Advanced Solid Tumors With CDKN2A Loss

A Phase 1b/2Study of Milademetan in Combination With Atezolizumab in Patients With Advanced Solid Tumors With CDKN2A Loss (MANTRA-4)

Status
Withdrawn
Phase
Phase 1 / Phase 2
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Rain Oncology Inc · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

This is an open-label, single-arm, Phase 1b/2 study designed to evaluate the safety, tolerability, and preliminary efficacy of milademetan in combination with atezolizumab in patients with advanced solid tumors with confirmed homozygous CDKN2A loss and WT TP53 who have progressed on or are refractory to prior PD-1/PD-L1 inhibitor therapy and who, in the opinion of the Investigator, are unlikely to tolerate or derive clinically meaningful benefit from other therapy. This study will determine the recommended dose of milademetan when given in combination with atezolizumab (the combination RP2D) using a dose de-escalation safety assessment cohort (Phase 1b). Following identification of the combination RP2D, the safety profile and preliminary anti-tumor activity of the combination RP2D will be evaluated in a larger population in a dose expansion cohort (Phase 2).

Detailed description

Up to 30 patients will be enrolled, 3 to 18 patients in the safety assessment cohort and 12 to 27 patients in the dose expansion cohort.

Conditions

Interventions

TypeNameDescription
DRUGMilademetan260 mg once daily orally on 3 consecutive day sets with a minimum of 14 days and a maximum of 21 days between the first day of each 3- day dosing set.
DRUGAtezolizumab1680mg administered every 4 weeks

Timeline

Start date
2023-05-19
Primary completion
2023-05-30
Completion
2023-05-30
First posted
2023-10-19
Last updated
2023-10-19

Regulatory

Source: ClinicalTrials.gov record NCT06090318. Inclusion in this directory is not an endorsement.