Study identifier:D6770C00001
ClinicalTrials.gov identifier:NCT04261075
EudraCT identifier:2019-004579-38
CTIS identifier:N/A
A Phase 1, First-in-Human, Multicenter, Open-label, Dose-escalation Study of IPH5201 as Monotherapy or in Combination with Durvalumab ± Oleclumab in Advanced Solid Tumors
Advanced Solid Tumors
Phase 1
No
IPH5201, Durvalumab
All
57
Interventional
18 Years - 101 Years
Allocation: Non-randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Jan 2025 by MedImmune, LLC
MedImmune, LLC
-
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 participants with advanced solid tumors.
Study D6770C00001 is a Phase 1, first-in-human, multicenter, open-label, dose-escalation study to evaluate the safety, tolerability, antitumor activity, pharmacokinetics, and immunogenicity of IPH5201 in adult participants with advanced solid tumors, when administered as monotherapy or in combination with durvalumab ± oleclumab.
Location
Location
BORDEAUX CEDEX, France, 33076
Location
Huntersville, NC, United States, 28078
Location
Nashville, TN, United States, 37203
Location
Providence, RI, United States, 02906
Location
Lausanne, Switzerland, 1011
Location
Villejuif, France, 94805
Location
Barcelona, Spain, 8035
Location
Madrid, Spain, 28027
Arms | Assigned Interventions |
---|---|
Experimental: Part 1: IPH5201 Dose Level 1 Participants will receive intravenous (IV) infusion of IPH5201 Dose Level 1 on Day 1 then every 3 weeks (Q3W) until confirmed disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met. | Drug: IPH5201 Participants will receive IV infusion of IPH5201 as stated in arm description. |
Experimental: Part 1: IPH5201 Dose Level 2 Participants will receive IV infusion of IPH5201 Dose Level 2 on Day 1 then Q3W until confirmed disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met. | Drug: IPH5201 Participants will receive IV infusion of IPH5201 as stated in arm description. |
Experimental: Part 1: IPH5201 Dose Level 3 Participants will receive IV infusion of IPH5201 Dose Level 3 on Day 1 then Q3W until confirmed disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met. | Drug: IPH5201 Participants will receive IV infusion of IPH5201 as stated in arm description. |
Experimental: Part 1: IPH5201 Dose Level 4 Participants will receive IV infusion of IPH5201 Dose Level 4 on Day 1 then Q3W until confirmed disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met. | Drug: IPH5201 Participants will receive IV infusion of IPH5201 as stated in arm description. |
Experimental: Part 2: IPH5201 Dose Level 2 + Durvalumab Participants will receive IV infusions of IPH5201 Dose Level 2 plus durvalumab 1500 mg on Day 1 then Q3W until confirmed disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met. | Drug: IPH5201 Participants will receive IV infusion of IPH5201 as stated in arm description. Drug: Durvalumab Participants will receive IV infusion of durvalumab as stated in arm description. Other Name: MEDI4736 |
Experimental: Part 2: IPH5201 Dose Level 3 + Durvalumab Participants will receive IV infusions of IPH5201 Dose Level 3 plus durvalumab 1500 mg on Day 1 then Q3W until confirmed disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met. | Drug: IPH5201 Participants will receive IV infusion of IPH5201 as stated in arm description. Drug: Durvalumab Participants will receive IV infusion of durvalumab as stated in arm description. Other Name: MEDI4736 |
Experimental: Part 2: IPH5201 Dose Level 4 + Durvalumab Participants will receive IV infusions of IPH5201 Dose Level 4 plus durvalumab 1500 mg on Day 1 then Q3W until confirmed disease progression, unacceptable toxicity, withdrawal of participant consent, or another discontinuation criterion was met. | Drug: IPH5201 Participants will receive IV infusion of IPH5201 as stated in arm description. Drug: Durvalumab Participants will receive IV infusion of durvalumab as stated in arm description. Other Name: MEDI4736 |
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