AzTrials
AzTrials

Salivary Gland CancerPhase 2NCT05010629

9-ING-41 Plus Carboplatin in Salivary Gland Carcinoma

A Phase 2 study testing 9-ING-41, Carboplatin and Pembrolizumab in people with Salivary Gland Cancer and Recurrent Salivary Gland Cancer, run by Robert Haddad, MD at 2 sites in United States.

Active, not recruiting

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

Official record
Search all trials

Trial summary

This trial is investigating an intravenous (IV) medication called 9-ING-41 in combination with chemotherapy (carboplatin) for the treatment of advanced salivary gland cancers. The names of the study drug(s) involved in this study are: 9-ING-41 (a GSK-3β inhibitor) Carboplatin chemotherapy Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
9-ING-41, Carboplatin and Pembrolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
2 sitesUnited States
Study dates
17 Sep 2021to 12 Apr 2027
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Participants must have histologically confirmed salivary gland carcinoma (any histologic subtype, including ACC) with evidence of recurrent, metastatic or advanced, unresectable disease.
  • Willing to provide tumor tissue from a diagnostic biopsy or prior surgery.
  • Age 18 years or older
  • ECOG performance status 0-2 (see Appendix A)
  • Participant must have organ and marrow function as defined below within 14 days prior to study registration:
  • leukocytes ≥ 3,000/mcL
Show all 19Show fewer
  • absolute neutrophil count ≥ 500/mcL
  • hemoglobin ≥ 8.5 g/dL
  • platelets ≥ 75,000/mcL
  • total bilirubin ≤ 2.0 g/dL
  • AST(SGOT)/ALT(SGPT) ≤ 2.5× institutional upper limit of normal
  • creatinine within normal institutional limits OR
  • creatinine clearance ≥50 mL/min/1.73 m2 for participants with creatinine levels above institutional normal
  • Participants must have documentation of a new or progressive lesion on a radiologic imaging study performed within 12 months prior to study registration (progression of disease over any interval is allowed) and/or new or worsening disease-related symptoms within 12 months prior to study registration. This assessment is performed by the treating investigator. Evidence of progression by RECIST v1.1 criteria not required.
  • Participants must have at least one RECIST v1.1 measurable non-CNS based lesion, as defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) ≥ 1 cm with CT scans or MR imaging.
  • Prior systemic therapy: At least 2 weeks must have elapsed since the end of prior chemotherapy, biological agents (3 weeks for anti-cancer monoclonal antibody containing regimens) or any investigational drug product, with adequate recovery of treatment-related toxicity to NCI CTCAE Version 5.0 grade ≤1 (or tolerable grade 2) or back to baseline (except for alopecia or neuropathy). Any number of prior therapies for recurrent/metastatic SGC are permitted (including prior carboplatin exposure); but prior therapy for recurrent/metastatic SGC is not required for participation.
  • Ability to understand and the willingness to sign a written informed consent document.
  • Female subjects of childbearing potential should have a negative urine or serum pregnancy test within 14 days of study registration. Female subjects of childbearing potential should have a negative urine or serum pregnancy test repeated within 72 hours prior to receiving the first dose of study medication. WOCBP will be instructed to adhere to contraception for a period of 90 days after the last dose of investigational product. "Women of childbearing potential (WOCBP)" is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level greater than 40 mIU/mL.
  • Men who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 90 days after the last dose of investigational product. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception. See Appendix B for further guidance on contraception.

Who cannot join

  • Metastatic disease impinging on the spinal cord or threatening spinal cord compression. Patients that have had previous treatment of disease with impinging on the cord with either surgery or radiotherapy with clinical or radiographic evidence of response or stability are eligible.
  • Participant has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment), and have no evidence of new or enlarging brain metastases.
  • Concurrent administration of other cancer specific therapy or investigational agents during the course of this study is not allowed.
  • Patients on anticoagulants that require INR monitoring (such as warfarin).
  • Uncontrolled intercurrent illness including but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
  • Pregnant or lactating women.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include: basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, and low-risk prostate adenocarcinoma being managed with active surveillance. A history of another separate malignancy in remission without evidence of active disease in the last 2 ears is permitted.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Phase 2 Study of 9-ING-41, a Glycogen Synthase Kinase 3 Beta (GSK 3β) Inhibitor, Plus Carboplatin in Patients With Advanced, Metastatic Salivary Gland Carcinoma

This trial is investigating an intravenous (IV) medication called 9-ING-41 in combination with chemotherapy (carboplatin) for the treatment of advanced salivary gland cancers.

The names of the study drug(s) involved in this study are:

  • 9-ING-41 (a GSK-3β inhibitor)
  • Carboplatin chemotherapy
Read the detailed description

This is a phase 2, open-label, non-randomized, single institution study investigating the novel glycogen synthase kinase-3 beta (GSK-3β) inhibitor 9-ING-41 in combination with carboplatin chemotherapy in patients with incurable, recurrent or metastatic salivary gland carcinomas (SGC).

The U.S. Food and Drug Administration (FDA) has not approved 9-ING-41 as a treatment for any disease. Carboplatin is used as a treatment for salivary gland cancers, and is approved by the FDA for many cancer types.

9-ING-41 has been identified in other studies as a therapy to block the over-expression of the glycogen synthase kinase-3 beta (GSK-3β) protein, which is thought to be important in signaling cancer growth and to have immune properties. It is believed that GSK-3β is over-expressed in salivary gland cancers and by blocking the action of GSK-3β protein with 9-ING-41 it could slow salivary cancer cell growth that have developed resistance to prior chemotherapy exposure.

The research study procedures include screening for eligibility and study treatment including evaluations and follow-up visits roughly every 3-weeks while on therapy, for up to one year as long as disease does not get worse and the drug therapy remains safe and tolerable.

It is expected that about 33 people treated will take part in this research study.

Actuate Therapeutics is supporting this research study by providing the study drug (9-ING-41) and funding some of the logistics of the trial that are beyond what would be considered standard of care.

Being tested
9-ING-41, Carboplatin, Pembrolizumab
Keywords
Salivary Gland Cancer, Recurrent Salivary Gland Cancer, Metastatic Salivary Gland Cancer, Adenoid Cystic Carcinoma
Medical subject headings
Salivary Gland Neoplasms, Neoplasm Metastasis, Carcinoma, Adenoid Cystic

What participants receive

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

  • 9-ING-41Drug

    Intravenous infusion

  • CarboplatinDrug

    Also called Paraplatin

    Intravenous infusion

  • PembrolizumabDrug

    Intravenous infusion

Study groups in NCT05010629
Study groupRoleWhat they receive
Pembrolizumab + 9-ING-41 + carboplatin (Part II)ExperimentalParticipants will receive: Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle (±3 days) for Cycles 1 and 2 (lead-in therapy). 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
Receives: Drug: 9-ING-41; Drug: Carboplatin; Drug: Pembrolizumab
9-ING-41 + carboplatin (Part I)ExperimentalParticipants will receive: 9-ING-41 administered twice per 21-day cycle on Day 1 and Day 4 for up to 1 year. Treatment with 9-ING-41 may continue beyond 1 year in participants with ongoing clinical benefit. Carboplatin administered once per 21-day cycle on Day 1 for up to 1 year.
Receives: Drug: 9-ING-41; Drug: Carboplatin

What is being measured

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

  1. Objective Response Rate (ORR)

    ORR was defined as the percentage of participants achieving complete response (CR) or partial response (PR) on treatment based on RECIST 1.1 criteria. Per RECIST 1.1 for target lesions: CR is complete disappearance of all target lesions and PR is at least a 30% decrease in the sum of longest diameter (LD) of target lesions, taking as reference baseline sum LD. PR or better overall response assumes at a minimum incomplete response/stable disease (SD) for the evaluation of non-target lesions and absence of new lesions.

    Measured: Tumor assessments were performed every 3 cycles (each cycle was 21 days), for up to 15.6 months.

Secondary outcomes (7)

  1. Median Progression Free Survival (PFS)

    PFS based on Kaplan-Meier is defined as the time from registration to the earlier of progressive disease (PD) or death due to any cause. Participants alive without disease progression are censored at date of last disease evaluation. Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.

    Measured: Tumor assessments were performed every 9 weeks for up to 20.2 months.

  2. Median Overall Survival (OS)

    Overall survival based on the Kaplan-Meier method is defined as the time from randomization to death. Participants alive are censored at the last date of contact (including lost-to-follow-up) or at the date of withdrawal of consent, if relevant.

    Measured: Up to 38.1 months

  3. Duration of Response (DOR)

    DOR is defined as the time from date of first documented confirmed objective response to date of first documented progressive disease (PD). Per RECIST 1.1 for target lesions: PD is at least a 20% increase in sum LD, taking as reference the smallest sum on study with at least 5 mm absolute increase. For non-target lesions, progression-free means no new lesions or unequivocal progression on existing non-target lesions or not evaluated.

    Measured: Tumor assessments were performed every 3 cycles (each cycle was 21 days), for up to 15.6 months.

  4. Number of Participants With Treatment Related Adverse Events (AE)

    Number of participants with treatment-related AE is defined as the number of participants who experienced at least one AE assessed as possibly, probably, or definitely related to study treatment according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0.

    Measured: AEs were assessed at Day 1 and Day 4 of each 21-day treatment cycle; assessed for up to 16.6 months.

  5. Mean Score of Global Question 1 in University of Washington Quality of Life Questionnaire (UW-QOL)

    UW-QOL Global Question 1 assessed how participants felt relative to before they developed their cancer. The mean score was calculated among all participants who provided a response to this question. Responses were recorded on a 5-point ordinal scale and transformed to a 0-100 score, where 0 = Much worse, 25 = Somewhat worse, 50 = About the same, 75 = Somewhat better, and 100 = Much better.

    Measured: Baseline and off-treatment (end-of-treatment) assessment; maximum treatment duration was 15.6 months.

  6. Mean Score of Global Question 2 in UW-QOL

    UW-QOL Global Question 2 assessed patients' health-related QOL during the past 7 days. The mean score was calculated among all participants who provided a response to this question. Responses were recorded on a 6-point ordinal scale and transformed to a 0-100 score, where 0 = Very Poor, 20 = Poor, 40 = Fair, 60 = Good, 80 = Very Good, and 100 = Outstanding.

    Measured: Baseline and off-treatment (end-of-treatment) assessment; maximum treatment duration was 15.6 months.

  7. Mean Score of Global Question 3 in UW-QOL

    UW-QOL Global Question 3 assessed patients' overall QOL during the past 7 days. The mean score was calculated among all participants who provided a response to this question. Responses were recorded on a 6-point ordinal scale and transformed to a 0-100 score, where 0 = Very Poor, 20 = Poor, 40 = Fair, 60 = Good, 80 = Very Good, and 100 = Outstanding.

    Measured: Baseline and off-treatment (end-of-treatment) assessment; maximum treatment duration was 15.6 months.

Timeline

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

  1. First posted18 Aug 2021
  2. Study start17 Sep 2021
  3. Primary completion14 Feb 2025
  4. Study completion12 Apr 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 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05010629
Sponsor's protocol ID
21-384
Status last verified
Jul 2026
First submitted
11 Aug 2021
Last updated
23 Oct 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing 9-ING-41, Carboplatin and Pembrolizumab in people with Salivary Gland Cancer and Recurrent Salivary Gland Cancer, run by Robert Haddad, MD at 2 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 19 inclusion and 7 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 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 phase mean?

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?

Yes. Results are posted in the registry (first posted 7 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Objective Response Rate (ORR) (time frame: Tumor assessments were performed every 3 cycles (each cycle was 21 days), for up to 15.6 months.). 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 NCT05010629.

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 23 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in