APG-115 in Salivary Gland Cancer Trial

• Status: Recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ascentage Pharma Group Inc.; University of Michigan Rogel Cancer Center
• Collaborators: Ascentage Pharma Group Inc.; University of Michigan
• Treatments: Carboplatin

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