NCT03781986

APG-115 in Salivary Gland Cancer Trial

A Multicenter Phase I/II Trial of a Novel MDM2 Inhibitor (APG-115) in p53 Wild-type Salivary Gland Carcinoma

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase I/II trial to evaluate the efficacy of APG-115 +/- Carboplatin for the treatment p53 wild-type malignant salivary gland cancer. Part 1 consisted of 2 arms, arm A (APG-115 monotherapy) and arm B (APG-115 + Carboplatin) and was terminated early. Part 2 is a single arm study (APG-115 monotherapy).

Detailed description

The current single arm study design was originally part of a study with a parallel arm given combination APG-115 + Carboplatin. In the initial phase of that previous iteration, the combination arm was closed early for issues related to tolerability of the combination therapy. This study will continue as a single arm, monotherapy alone, Phase I/II study as approved by the UM Institutional Review Board as of June 2021.

Conditions

• Malignant Salivary Gland Cancer
• Salivary Gland Cancer

Interventions

Type	Name	Description
DRUG	APG-115	APG-115 at 150mg (or lower, if dose is reduced) is taken orally every other day through day 13 of each cycle. Cycle length 21 days.
DRUG	Carboplatin	Carboplatin is given IV at AUC=4.5 on day 1 of each cycle. Cycle length 21 days.

Timeline

• Start date: 2019-10-28
• Primary completion: 2026-07-01
• Completion: 2027-01-01
• First posted: 2018-12-20
• Last updated: 2026-03-03

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study