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

Sponsor
Rain Oncology Inc
Study ID
NCT06090318
Phase
PHASE1/PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Milademetan — DRUG
    260 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.
  • Atezolizumab — DRUG
    1680mg administered every 4 weeks

Study Details

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).

Key Dates

Start date
May 19, 2023
Status verified
Oct 2023
Primary completion
May 30, 2023
Completion
May 30, 2023

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Milademetan (RAIN-32) in Combination With Atezolizumab
    Milademetan (RAIN-32): 260 mg 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. Atezolizumab: Atezolizumab IV infusion is to be administered on Day 1 of each 28- day cycle.

Primary Outcome Measure

The number of participants with treatment related AEs meeting DLT-defined criteria assessed by CTCAE v5.0 when receiving milademetan in combination with atezolizumab in patients with advanced solid tumors with HZ CDKN2A loss and WT TP53 [ Time Frame: 4 months ]

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