A Phase 1 Study to Investigate Axatilimab Alone or in Combination With Durvalumab in Patients With Solid Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Syndax Pharmaceuticals
Study ID
NCT03238027
Phase
PHASE1
Status
Completed

Conditions

  • Locally Advanced Malignant Neoplasm
  • Metastatic Tumor
  • Solid Tumor
  • Unresectable Malignant Neoplasm

Eligibility Criteria

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

Interventions

  • Axatilimab — DRUG
    Humanized IgG4 mAb that blocks colony stimulating factor 1 receptor (CSF-1R)
  • Durvalumab — DRUG
    Durvalumab (MEDI4736) is a humanized IgG1 kappa mAb that blocks the interaction of PD-L1 with PD-1 CD80 (B7.1) molecules

Study Details

A Phase 1 dose escalation study to determine if axatilimab as monotherapy and axatilimab in combination with a fixed dose of durvalumab will be sufficiently safe and well-tolerated at biologically active doses to warrant further investigation in patients with solid tumors.

Key Dates

Start date
Sep 1, 2017
Status verified
May 2024
Primary completion
Nov 20, 2020
Completion
Nov 20, 2020

Study Design

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

Arms

  • Experimental: Ph1a D1: 1 mg/kg Axatilimab
    Three (3) patients receive starting dose of 1 mg/kg of axatilimab and are followed for possible DLTs. If one DLT is observed in 1 of 3 patients, an additional 3 patients will be enrolled at this dose level. If no DLTs are noted in any of the 3 patients, next dosing arm will commence following review by Scientific Review Committee.
  • Experimental: Ph1a D2: 3 mg/kg Axatilimab
    Three (3) patients receive next higher dose of 3 mg/kg of axatilimab and are followed for possible DLTs. If one DLT is observed in 1 of 3 patients, an additional 3 patients will be enrolled at this dose level. If no DLTs are noted in any of the 3 patients, next dosing arm will commence following review by Scientific Review Committee.
  • Experimental: Ph1a D3: 6 mg/kg Axatilimab
    Three (3) patients receive next higher dose of 6 mg/kg of axatilimab and are followed for possible DLTs. If one DLT is observed in 1 of 3 patients, an additional 3 patients will be enrolled at this dose level. If no DLTs are noted in any of the 3 patients, next dosing arm will commence following review by Scientific Review Committee.
  • Experimental: Ph1a D4: 10 mg/kg Axatilimab
    Three (3) patients receive next higher dose of 10 mg/kg of axatilimab and are followed for possible DLTs. If one DLT is observed in 1 of 3 patients, an additional 3 patients will be enrolled at this dose level. If no DLTs are noted in any of the 3 patients, next dosing arm will commence following review by Scientific Review Committee.
  • Experimental: Ph1b D1: 1 mg/kg Axatilimab+1500 mg durvalumab
    Three (3) patients receive starting dose of 1 mg/kg of axatilimab every two weeks and 1500 mg durvalumab every four weeks and are followed for possible DLTs. If one DLT is observed in 1 of 3 patients, an additional 3 patients will be enrolled at this dose level. If no DLTs are noted in any of the 3 patients, next dosing arm will commence following review by Scientific Review Committee. If 1 DLT is observed in 1 of 3 patients, then 3 additional patients will be treated at the 1 mg/kg axatilimab dose level; if none of the 3 additional patients experience a DLT (i.e. 1 of 6), the dose will be escalated to an intermediate dose of 2 mg/kg. Escalation from 2 mg/kg to 3 mg/kg will follow the general dose escalation rules described above for both study phases.
  • Experimental: Ph1b D2: 3 mg/kg Axatilimab+1500 mg durvalumab
    Three (3) patients receive next higher dose of 3 mg/kg of axatilimab every two weeks and 1500 mg durvalumab every four weeks and are followed for possible DLTs. For cohorts with doses ≥3 mg/kg, a sentinel recruitment approach will be utilized. Initially 1 patient in each cohort will be treated with the combination therapy and safety will be evaluated by SRC at Cycle 1, Day 8; if no safety concerns are identified, the next 2 patients can be treated in that cohort. If one DLT is observed in 1 of 3 patients, an additional 3 patients will be enrolled at this dose level. If no DLTs are noted in any of the 3 patients, next dosing arm will commence following review by Scientific Review Committee.
  • Experimental: Ph1b D3: 6 mg/kg Axatilimab+1500 mg durvalumab
    Three (3) patients receive next higher dose of 6 mg/kg of axatilimab every two weeks and 1500 mg durvalumab every four weeks and are followed for possible DLTs. For cohorts with doses ≥3 mg/kg, a sentinel recruitment approach will be utilized. Initially 1 patient in each cohort will be treated with the combination therapy and safety will be evaluated by SRC at Cycle 1, Day 8; if no safety concerns are identified, the next 2 patients can be treated in that cohort. If one DLT is observed in 1 of 3 patients, an additional 3 patients will be enrolled at this dose level. If no DLTs are noted in any of the 3 patients, next dosing arm will commence following review by Scientific Review Committee.

Primary Outcome Measure

Phase 1a: Determination of any Dose limiting toxicities (DLT)s of Axatilimab [ Time Frame: Approximately 9 months (from first dose to 90-day follow-up post-last dose) ]

Locations (5)

FacilityCityStateZIPSite coordinators
Honor HealthScottsdaleArizona85258-
Johns Hopkins UniversityBaltimoreMaryland21287-
Oregon Health and Science UniversityPortlandOregon97239-
NEXT OncologySan AntonioTexas78229-
South Texas Accelerated Research TherapeuticsSan AntonioTexas78229-

Find similar trials in Scottsdale, AZ

By research site
Honor Health· Scottsdale, AZJohns Hopkins University· Baltimore, MDOregon Health and Science University· Portland, ORNEXT Oncology· San Antonio, TXSouth Texas Accelerated Research Therapeutics· San Antonio, TX

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