First Time in Human Study of AZD8701 With or Without Durvalumab in Participants With Advanced Solid Tumours

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
AstraZeneca
Study ID
NCT04504669
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 101 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD8701 — DRUG
    FOXP3 antisense oligonucleotide
  • Durvalumab — BIOLOGICAL
    anti PDL-1 monoclonal antibody

Study Details

The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of AZD8701 Alone and in Combination with Durvalumab (MEDI4736) in Adult Subjects with Select Advanced Solid Tumors

Key Dates

Start date
Aug 18, 2020
Status verified
Nov 2024
Primary completion
Oct 7, 2024
Completion
Oct 7, 2024

Study Design

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

Arms

  • Experimental: Monotherapy
    Participants will receive AZD8701 intravenously, on Day 1, 3, 5 and 8 and then weekly for a maximum of 2 years.
  • Experimental: Combination Therapy
    Participants will receive AZD8701 (intravenously, on Day 1, 3, 5 and 8 and then weekly) and durvalumab (MEDI4736) intravenously monthly for a maximum of 2 years.

Primary Outcome Measure

Maximum Tolerated dose (or optimal dose or maximum feasible dose) and RP2D of AZD8701 as monotherapy and in combination with Durvalumab assessed through evaluation of AEs and SAEs [ Time Frame: From screening until 105 days after last dose of study treatment ]

Locations (6)

FacilityCityStateZIPSite coordinators
Research SiteBaltimoreMaryland21287-
Research SiteSt LouisMissouri63110-
Research SiteHuntersvilleNorth Carolina28078-
Research SiteFranklinTennessee37067-
Research SiteHoustonTexas77030-
Research SiteMadisonWisconsin53792-

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