A Phase 1/2 interventional study of APG-115 and Carboplatin in Malignant Salivary Gland Cancer and Salivary Gland Cancer, sponsored by University of Michigan Rogel Cancer Center. Active, not recruiting at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-13.
Sponsored by University of Michigan Rogel Cancer Center · Phase 1/2, Interventional, and Treatment
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).
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.
156 studies on the registry are indexed under Salivary Gland Neoplasms; 29 are open to participants now.
This study's enrollment of 41 is above the median of 36 across 133 interventional studies indexed under Salivary Gland Neoplasms.
Browse Salivary Gland Neoplasms studies →University of Michigan Rogel Cancer Center is the lead sponsor of 316 studies on the registry; 46 are open to participants now.
Of its 46 completed or terminated interventional studies of FDA-regulated products, 30 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
APG-115 will be administered in an open label fashion until progression, intolerance, or patient preference.
Drug: APG-115
APG-115 and Carboplatin will be administered in an open label fashion until progression, intolerance, or patient preference. \[Phase 1 was terminated early and this arm was discontinued. An MTD was not established during Phase 1.\]
Drug: APG-115 · Drug: Carboplatin
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 is given IV at AUC=4.5 on day 1 of each cycle. Cycle length 21 days.
Primary Toxicity Endpoint: dose-limiting toxicity (DLT)
DLT will be defined based on the rate of drug-related grade 3-5 adverse events experienced within the first 6 weeks (2 cycles) of study treatment. These will be assessed via CTCAE version 5.0
Time frame: 42 days
Maximally tolerated dose (MTD)
MTD will be determined based on DLTs observed during the first 6 weeks (2 cycles) of study treatment.
Time frame: 42 days
Overall response rate
Overall response rate will be defined as the proportion of patients achieving either complete response (CR) or partial response (PR). Response will be assessed via RECIST v1.1.
Time frame: up to 12 months
Overall response rate by tumor histology
Overall response rate will be defined as the proportion of patients achieving either complete response (CR) or partial response (PR), assessed via RECIST v1.1 and reported separately for those with histologically confirmed adenoid cystic carcinoma (ACC) versus other malignant salivary gland tumors (non-ACC)
Time frame: Until death or end of study; up to approximately 5 years
Duration of response
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Stable disease is measured from the start of the treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started.
Time frame: Until death or end of study; up to approximately 5 years
Progression-free survival
Progression-free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever is earlier.
Time frame: Until death or end of study; up to approximately 5 years
Overall survival
Overall survival (OS) is defined as the duration of time from start of treatment to time of death or end of study.
Time frame: Until death or end of study; up to approximately 5 years
Disease control rate
Defined as the proportion of patients achieving complete response (CR), partial response (PR), or stable disease (SD). Response will be assessed via RECIST v1.1
Time frame: Until death or end of study; up to approximately 5 years
Plan to share: No
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This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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University of Michigan Rogel Cancer Center