APG-115 in Salivary Gland Cancer Trial

NCT ID: NCT03781986

Last Updated: 2026-01-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-28
• Study Completion Date: 2026-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

APG-115 monotherapy

APG-115 will be administered in an open label fashion until progression, intolerance, or patient preference.

Group Type: EXPERIMENTAL

APG-115

Intervention Type: DRUG

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.

APG-115 + Carboplatin [terminated]

APG-115 and Carboplatin will be administered in an open label fashion until progression, intolerance, or patient preference. \[Phase 1 was terminated early and this arm was discontinued. An MTD was not established during Phase 1.\]

Group Type: EXPERIMENTAL

APG-115

Intervention Type: DRUG

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.

Carboplatin

Intervention Type: DRUG

Carboplatin is given IV at AUC=4.5 on day 1 of each cycle. Cycle length 21 days.

Interventions

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.

Intervention Type: DRUG

Carboplatin

Carboplatin is given IV at AUC=4.5 on day 1 of each cycle. Cycle length 21 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically documented malignant salivary gland cancers (including secretory glands of the aerodigestive tract) with or without metastases, not amenable to curative treatment; or there is documentation of patient refusal of curative treatment.
• Previous mutational testing with no evidence of a p53 mutation
• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
• Presence of measurable disease by CT scan per RECIST v1.1 with ≥ 20% increase in tumor burden in the preceding 12 months
• Life expectancy of ≥12 weeks
• Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment
• Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
• Patients must be able to take oral medication without breaking/opening, crushing, dissolving, or chewing capsules
• Adequate organ and marrow function obtained ≤ 2 weeks prior to enrollment

Exclusion Criteria

• Prior treatment with MDM2 inhibitors
• Patients are not eligible if they have received any systemic anti-cancer therapy (including chemotherapy and/or hormone therapy) for salivary gland cancer within 4 weeks of the start of study therapy
• Patients are not eligible if they have received any of the following within 4 weeks of the start of study therapy: live vaccines, antiretroviral drugs
• Progressive disease within 6 months of the last dose of platinum-based chemotherapy
• Patients with active brain metastases are excluded because of unknown penetration into the central nervous system (CNS). A confirmatory scan for asymptomatic patients is not required. Patients with a history of treated CNS metastases are eligible provided they meet all of the following criteria: disease outside the CNS is present, no clinical evidence of progression since completion of CNS-directed therapy, minimum 4 weeks between completion of radiotherapy and enrollment, and recovery from significant (Grade ≥ 3) acute toxicity.
• A serious uncontrolled medical disorder or active infection that would impair their ability to receive study treatment
• Patients (male and female) having procreative potential who are not willing or not able to use 2 adequate methods of contraception or practicing abstinence during the study and for 90 days following their last dose of treatment
• Women who are pregnant or breast-feeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ascentage Pharma Group Inc.

INDUSTRY

Sponsor Role: collaborator

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul L Swiecicki, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

Moffitt Cancer Center

Tampa, Florida, United States

University of Chicago

Chicago, Illinois, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

Other Identifiers

APG-115SG101

Identifier Type: OTHER

Identifier Source: secondary_id

HUM00155822

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2018.127

Identifier Type: -

Identifier Source: org_study_id