MEDI9447 Alone and in Combination With MEDI4736 in Adult Participants With Select Advanced Solid Tumors.

Part of paid clinical trials in La Jolla, California.

Sponsor
MedImmune LLC
Study ID
NCT02503774
Phase
PHASE1
Status
Completed

Conditions

  • Solid Tumors

Eligibility Criteria

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

Interventions

  • Oleclumab — DRUG
    Participants will receive IV infusion of oleclumab as stated in arms' description.
  • Durvalumab — DRUG
    Participants will receive IV infusion of durvalumab as stated in arms' description.

Study Details

The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Antitumor Activity of MEDI9447 Alone and in Combination with MEDI4736 in Adult Participants with Select Advanced Solid Tumors

Key Dates

Start date
Jul 24, 2015
Status verified
Jul 2023
Primary completion
Jan 22, 2021
Completion
Mar 7, 2023

Study Design

Enrollment
192 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose-escalation: Oleclumab Dose 1
    Participants will receive oleclumab Dose 1 intravenously (IV) every two weeks (Q2W) until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
  • Experimental: Dose-escalation: Oleclumab Dose 2
    Participants will receive oleclumab Dose 2 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
  • Experimental: Dose-escalation: Oleclumab Dose 3
    Participants will receive oleclumab Dose 3 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
  • Experimental: Dose-escalation: Oleclumab Dose 4
    Participants will receive oleclumab Dose 4 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
  • Experimental: Dose-escalation: Oleclumab Dose 1 + Durvalumab Dose 1
    Participants will receive oleclumab Dose 1 IV Q2W followed by durvalumab Dose 1 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
  • Experimental: Dose-escalation: Oleclumab Dose 2 + Durvalumab Dose 1
    Participants will receive oleclumab Dose 2 IV Q2W followed by durvalumab Dose 1 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
  • Experimental: Dose-escalation: OleclumabDose 3 + Durvalumab Dose 1
    Participants will receive oleclumab Dose 3 IV Q2W followed by durvalumab Dose 1 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
  • Experimental: Dose-escalation: OleclumabDose 4 + Durvalumab Dose 1
    Participants will receive oleclumab Dose 4 IV Q2W followed by durvalumab Dose 1 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
  • Experimental: Dose-expansion (CRC): Oleclumab Dose 4 + Durvalumab Dose 1
    Participants with previously treated microsatellite stable-colorectal cancer (MSS-CRC) will receive oleclumab Dose 4 IV Q2W followed by durvalumab Dose 1 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
  • Experimental: Dose-expansion (Pancreatic adenocarcinoma): Oleclumab Dose 4+ Durvalumab Dose 1
    Participants with previously treated pancreatic adenocarcinoma will receive oleclumab Dose 4 IV Q2W followed by durvalumab Dose 1 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
  • Experimental: Dose-expansion (NSCLC): Oleclumab Dose 4 + Durvalumab Dose 1
    Participants with previously treated EGFRm NSCLC will receive oleclumab Dose 4 IV followed by durvalumab Dose 1 IV Q2W until confirmed disease progression, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLTs) in Dose-escalation Phase [ Time Frame: From Day 1 to Day 28 after first dose of study drug ]

Locations (11)

FacilityCityStateZIPSite coordinators
Research SiteLa JollaCalifornia92093-
Research SiteNew HavenConnecticut06510-
Research SiteGainesvilleFlorida32610-
Research SiteAtlantaGeorgia30318-
Research SiteSt LouisMissouri63156-
Research SiteDurhamNorth Carolina27705-
Research SiteCincinnatiOhio45267-
Research SiteColumbusOhio43210-
Research SiteNashvilleTennessee37203-
Research SiteDallasTexas75230-
Research SiteHoustonTexas77030-

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