9-ING-41 Plus Carboplatin in Salivary Gland Carcinoma

NCT05010629 | Active Not Recruiting Phase 2 Results DMC FDA Drug

• 1 other identifier: 21-384
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Salivary Gland Cancer; Recurrent Salivary Gland Cancer; Metastatic Cancer; Adenoid Cystic Carcinoma

Keywords

Salivary Gland Cancer; Recurrent Salivary Gland Cancer; Metastatic Salivary Gland Cancer; Adenoid Cystic Carcinoma

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (7)

• Median Progression Free Survival (PFS)

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

• Median Overall Survival (OS)

  Up to 38.1 months

• Duration of Response (DOR)

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

• Number of Participants With Treatment Related Adverse Events (AE)

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

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

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

Study Arms (2)

Pembrolizumab + 9-ING-41 + carboplatin (Part II)

EXPERIMENTAL

Participants 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.

Drug: 9-ING-41; Drug: Carboplatin; Drug: Pembrolizumab

9-ING-41 + carboplatin (Part I)

EXPERIMENTAL

Participants 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.

Drug: 9-ING-41; Drug: Carboplatin

Interventions

9-ING-41 DRUG

Intravenous infusion

9-ING-41 + carboplatin (Part I); Pembrolizumab + 9-ING-41 + carboplatin (Part II)

Carboplatin DRUG

Intravenous infusion

Also known as: Paraplatin

9-ING-41 + carboplatin (Part I); Pembrolizumab + 9-ING-41 + carboplatin (Part II)

Pembrolizumab DRUG

Intravenous infusion

Pembrolizumab + 9-ING-41 + carboplatin (Part II)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Glenn J. Hanna: lead
• Actuate Therapeutics Inc.: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Salivary Gland Neoplasms; Neoplasm Metastasis; Carcinoma, Adenoid Cystic

Interventions

3-(5-fluorobenzofuran-3-yl)-4-(5-methyl-5H-(1,3)dioxolo(4,5-f)indol-7-yl)-pyrrole-2,5-dione; Carboplatin; pembrolizumab

Condition Hierarchy (Ancestors)

Mouth Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Limitations and Caveats

Smaller overall sample size limiting some subgroup analyses.

Results Point of Contact

• Title: Glenn J. Hanna
• Organization: Dana-Farber Cancer Institute

glenn_hanna@dfci.harvard.edu

617-632-3090

Study Officials

• Glenn J Hanna, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 11, 2021
• First Posted: August 18, 2021
• Study Start: September 17, 2021
• Primary Completion: February 14, 2025
• Study Completion (Estimated): April 12, 2027
• Last Updated: August 7, 2026
• Results First Posted: August 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (2)