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 Jun 2024 by MedImmune, LLC
MedImmune, LLC
-
No locations available
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 |