9-ING-41 Plus Carboplatin in Salivary Gland Carcinoma

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Glenn J. Hanna
Study ID
NCT05010629
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 9-ING-41 — DRUG
    Intravenous infusion
  • Carboplatin — DRUG
    Intravenous infusion
  • Pembrolizumab — DRUG
    Intravenous infusion

Study Details

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

Key Dates

First listed
Aug 18, 2021
Start date
Sep 17, 2021
Status verified
Jul 2026
Primary completion
Feb 14, 2025
Completion
Apr 12, 2027

Study Design

Enrollment
32 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Pembrolizumab + 9-ING-41 + carboplatin (Part II)
    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.
  • Experimental: 9-ING-41 + carboplatin (Part I)
    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.

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. ]

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-
Dana Farber Cancer InstituteBostonMassachusetts02115-

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By research site
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