Trial of Selumetinib and Bromodomain Inhibitor With Durvalumab for Sarcomas

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT05253131
Phase
PHASE2
Status
Recruiting
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Conditions

  • MPNST
  • NF1
  • Sarcoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

A multi-institutional open-label phase 1/2 trial of selumetinib in combination with ZEN-3694 and durvalumab in refractory/unresectable sarcomas including MPNST. The phase 1 portion will be separated in two parts and will be open to all patients with refractory/relapsed sarcomas. The phase 2 portion will be for patients with refractory/unresectable NF1-associated MPNST.

Key Dates

First listed
Feb 23, 2022
Start date
Aug 4, 2026
Status verified
Aug 2026
Primary completion
Nov 15, 2031
Completion
Nov 15, 2032

Study Design

Enrollment
41 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 and 2 Study of Selumentinib, ZEN-3694 and Durvalumab
    Part A will be a phase 1 dose escalation study of the combination with selumetinib and ZEN-3694. Part B will be phase 1 study combining the determined dose of selumetinib and ZEN-3694 from Part A with durvalumab. Part C will be a phase 2 study combining selumetinib, ZEN-3694 with durvalumab in MPNST patients at the recommended doses from part B. A Simon's two-stage design will be used in the phase 2 trial to determine the clinical benefit in patients with unresectable or metastatic NF associated MPNST.

Primary Outcome Measure

Part A: Safety and Tolerability Selumetinib with ZEN-3694 [ Time Frame: From first dose through the end of the first treatment cycle for each participant at each dose level (up to 28 days). ]

Locations (1)

FacilityCityStateZIPSite coordinators
Children's of AlabamaBirminghamAlabama35294
Girish Dhall, MD
[email protected]
205.638.6259
Manjul Virmani, MSRA
[email protected]
(205) 638-5450
Girish Dhall, MD (PRINCIPAL_INVESTIGATOR)
Laura "Katie" Metrock, MD (SUB_INVESTIGATOR)

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By research site
Children's of Alabama· Birmingham, AL

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