Study to Investigate DRP-104 in Adults With Advanced Solid Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Dracen Pharmaceuticals, Inc.
Study ID
NCT04471415
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

  • Advanced Solid Tumor
  • Non Small Cell Lung Cancer Metastatic

Eligibility Criteria

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

Interventions

  • DRP-104 — DRUG
    DRP-104 administered intravenously over 1 hour, three times per week (TIW) (Monday, Wednesday, Friday) for 2 consecutive weeks, one week off DRP-104 administered subcutaneously twice weekly (Monday/Thursday or Tuesday/Friday) every week OR thrice weekly (Monday, Wednesday, Friday) every week
  • atezolizumab — BIOLOGICAL
    atezolizumab administered intravenously over 1 hour at 1200 mg once every 3 weeks.

Study Details

The purpose of this study is to characterize the safety, tolerability, pharmacokinetics, pharmaco-dynamics and preliminary anti-tumor activity of DRP-104 (sirpiglenastat) administered via intravenous infusion or via subcutaneous injection as a single agent and in combination with atezolizumab in patients with advanced solid tumors and to assess preliminary safety and efficacy of which route of administration (intravenous or subcutaneous) will be selected for further development for the one expansion of patients, advanced non-small cell lung cancer (NSCLC) with defined genetic mutations.

Key Dates

Start date
Aug 31, 2020
Status verified
Jun 2023
Primary completion
Mar 28, 2023
Completion
Mar 28, 2023

Study Design

Enrollment
61 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1a & Part 1b
    Single-agent dose escalation of DRP-104 to define the MTD (up to approximately 50 patients) starting at Dose Level 1 of 3.3 mg/m2 via intravenous injection Single-agent dose escalation of DRP-104 to define the MTD (up to approximately 50 patients) starting at Dose Level 1 at 10 mg via subcutaneous injection
  • Experimental: Part 2
    Cohort 1: Phase 1 single-agent safety expansion of DRP-104 administered subQ (the RP2R) in patients with advanced solid tumors (excluding primary CNS tumors and HCC). DRP-104 will be administered twice weekly subQ in this safety expansion at the twice weekly subQ MTD/MAD/RP2D of DRP-104 determined in Part 1-Cohort 1b. A minimum of 14 and up to 20 patients will be enrolled. Cohort 2: Phase 2a expansion at the MTD/MAD/RP2D/RP2R and schedule of administration (subQ twice or thrice weekly) of DRP-104 in patients with locally advanced or metastatic NSCLC whose tumors contain a known mutation in kelchlike ECH-associated protein 1 (KEAP1), nuclear factor erythroid 2-related factor 2 (NFE2L2) and/or serine/threonine kinase 11 (STK11), (N=55). If the thrice weekly schedule is selected as the RP2S, a safety review will be conducted after 8 patients have enrolled and are followed for at least one cycle of treatment before additional patients are enrolled into Part 2-Cohort 2.
  • Experimental: Part 3
    Phase 1 combination dose escalation of DRP-104 and atezolizumab in patients with advanced solid tumors (excluding primary CNS tumors and HCC) previously treated with an agent targeting checkpoint pathway inhibition (such as anti-PD-1, anti-PD-L1, and/or anti-CTLA-4 antibody), starting one dose level below the MTD/MAD/RP2D (MTD-1) of the recommended phase 2 route and schedule of administration of singleagent DRP-104 and in combination with 1200 mg atezolizumab administered via intravenous infusion on day 1 and repeated every 3 weeks (up to approximately 12 patients);
  • Experimental: Part 4
    Phase 1 combination safety expansion at the MTD/MAD/RP2D, route, and schedule of administration of DRP-104 with atezolizumab in a similar patient population as the dose-escalation (N=14 patients).

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: anticipated 2 year ]

Locations (13)

FacilityCityStateZIPSite coordinators
HonorHealthScottsdaleArizona85258-
UCLALos AngelesCalifornia90095-
AdventHealth Medical GroupKissimmeeFlorida34747-
Florida Cancer SpecialistOrlandoFlorida32827-
Johns Hopkins Kimmel InstituteBaltimoreMaryland21231-
Dana Farber Cancer InstituteBostonMassachusetts02215-
Icahn School of Medicine at Mount SinaiNew YorkNew York10029-6574-
NYU LangoneNew YorkNew York10016-
University of North CarolinaChapel HillNorth Carolina27514-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Sarah Cannon Research InstituteNashvilleTennessee37203-
Vanderbilt University Medical CenterNashvilleTennessee37232-
NEXT OncologyFairfaxVirginia22031-

Find similar trials in Scottsdale, AZ

By research site
HonorHealth· Scottsdale, AZUCLA· Los Angeles, CAAdventHealth Medical Group· Kissimmee, FLFlorida Cancer Specialist· Orlando, FLJohns Hopkins Kimmel Institute· Baltimore, MDDana Farber Cancer Institute· Boston, MA

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