IPH5201 as Monotherapy or in Combination With Durvalumab +/- Oleclumab in Subjects With Advanced Solid Tumors.

Part of paid clinical trials in Huntersville, North Carolina.

Sponsor
MedImmune LLC
Study ID
NCT04261075
Phase
PHASE1
Status
Completed

Conditions

  • Advanced Solid Tumors

Eligibility Criteria

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

Interventions

  • IPH5201 — BIOLOGICAL
    Ascending dose levels of IPH5201 every 3 weeks (Q3W) for a maximum of 2 years
  • durvalumab — BIOLOGICAL
    Durvalumab Q3W for a maximum of 2 years
  • oleclumab — BIOLOGICAL
    Oleclumab Q3W for a maximum of 2 years

Study Details

The purpose of this study is to assess the safety and tolerability and to determine the dose of IPH5201 that can be used as monotherapy or in combination with durvalumab +/- oleclumab in subjects with advanced solid tumors.

Key Dates

Start date
Mar 3, 2020
Status verified
Aug 2022
Primary completion
Jun 16, 2022
Completion
Jun 16, 2022

Study Design

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

Arms

  • Experimental: IPH5201 monotherapy dose escalation
    IPH5201 monotherapy
  • Experimental: IPH5201 dose escalation with durvalumab
    IPH5201 plus durvalumab
  • Experimental: IPH5201 dose escalation with durvalumab + oleclumab
    IPH5201 plus durvalumab and oleclumab

Primary Outcome Measure

Incidence of adverse events as a measure of safety [ Time Frame: From time of informed consent through treatment period and including the follow-up 12 weeks after last dose of investigational product, approximately 7 months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Research SiteHuntersvilleNorth Carolina28078-
Research SiteProvidenceRhode Island02906-
Research SiteNashvilleTennessee37203-

Find similar trials in Huntersville, NC

By research site
Research Site· Huntersville, NCResearch Site· Providence, RIResearch Site· Nashville, TN

Related Studies