Can a new drug combo shrink Hard-to-Treat salivary gland tumors?
NCT ID NCT05010629
First seen Aug 07, 2026 · Last updated Aug 07, 2026
Summary
This phase 2 trial is testing whether an experimental drug called 9-ING-41, when combined with the chemotherapy drug carboplatin, can help people with advanced or metastatic salivary gland cancer. The study aims to see if the combination can shrink tumors or slow their growth. Participants receive both drugs through an IV, and the trial will measure how many people respond to treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 9-ING-41 (a GSK-3β inhibitor) combined with carboplatin chemotherapy
- What this could lead to
- If effective, this combination could offer a new treatment option to slow or shrink advanced salivary gland tumors, potentially improving outcomes for patients with limited choices.
- What could go wrong
- This is a phase 2 trial with a small number of participants, so results may not be conclusive. The drug combination may cause side effects, and it is not yet known if it will work better than standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
32 people
The number who actually took part.
- Started
-
Sep 2021
- Expected to finish
-
Apr 2027
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * 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. Exclusion Criteria: * 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Adenoid cystic carcinoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
-
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- New drug targets Sugar-Coated proteins on cancer cells
- New antibody aims to preserve immune checkpoint while fighting cancer
- Two-Drug combo targets Hard-to-Treat salivary gland tumors
- Zapping a few growing tumors may keep breast cancer drugs working longer
- Can a platform trial match the right drug combo to each tumor?
- Can a new antibody help the immune system fight Hard-to-Treat tumors?