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Malignant Salivary Gland CancerPhase 1/2NCT03781986

APG-115 in Salivary Gland Cancer Trial

A Phase 1/2 study testing APG-115 and Carboplatin in people with Malignant Salivary Gland Cancer and Salivary Gland Cancer, run by University of Michigan Rogel Cancer Center at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
APG-115 and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
3 sitesUnited States
Study dates
28 Oct 2019to Jan 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • University of Michigan Rogel Cancer Center

    Ann Arbor, Michigan, 48109

  • University of Chicago

    Chicago, Illinois, 60637

  • Moffitt Cancer Center

    Tampa, Florida, 33612

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
APG-115, Carboplatin
Keywords
p53 wild-type, Adenoid cystic carcinoma
Medical subject headings
Salivary Gland Neoplasms, Carcinoma, Adenoid Cystic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APG-115Drug

    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.

  • CarboplatinDrug

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

Study groups in NCT03781986
Study groupRoleWhat they receive
APG-115 monotherapyExperimentalAPG-115 will be administered in an open label fashion until progression, intolerance, or patient preference.
Receives: Drug: APG-115
APG-115 + Carboplatin [terminated]ExperimentalAPG-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.]
Receives: Drug: APG-115; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 42 days

  2. Maximally tolerated dose (MTD)

    MTD will be determined based on DLTs observed during the first 6 weeks (2 cycles) of study treatment.

    Measured: 42 days

  3. 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.

    Measured: up to 12 months

Secondary outcomes (5)

  1. 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)

    Measured: Until death or end of study; up to approximately 5 years

  2. 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.

    Measured: Until death or end of study; up to approximately 5 years

  3. 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.

    Measured: Until death or end of study; up to approximately 5 years

  4. Overall survival

    Overall survival (OS) is defined as the duration of time from start of treatment to time of death or end of study.

    Measured: Until death or end of study; up to approximately 5 years

  5. 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

    Measured: Until death or end of study; up to approximately 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2018
  2. Study start28 Oct 2019
  3. Primary completion19 Jan 2026
  4. Study completionJan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Part 1 -- Parallel assignment \[terminated early\]: * Arm A: APG-115 Monotherapy * Arm B: APG-115 + Carboplatin Part 2 -- Single arm (Arm A only): APG-115 Monotherapy
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03781986
Sponsor's protocol ID
UMCC 2018.127
Other IDs
APG-115SG101, HUM00155822
Status last verified
Jul 2026
First submitted
6 Dec 2018
Last updated
13 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing APG-115 and Carboplatin in people with Malignant Salivary Gland Cancer and Salivary Gland Cancer, run by University of Michigan Rogel Cancer Center at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Toxicity Endpoint: dose-limiting toxicity (DLT) (time frame: 42 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03781986.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.

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