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A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy

StatusRecruiting
PhasePhase 1/2
Started2024-08-23
View on ClinicalTrials.gov ↗
This study is an open-label Phase Ib (Part A) dose escalation followed by a blinded, randomized, multi cohort Phase 2a (Part B) comparison of combination vs. reference regimens. Currently study will only be enrolling the Phase 1b and the Phase 2a protocol requirements will be added to the study near completion of the Phase 1b

Amendment record

Amended 7 times since 2024-04-11; most recent filed 2026-04-07. Every amendment is listed below.

Dates here are the day the sponsor filed the amendment, not the day ClinicalTrials.gov published it. Version history last read from ClinicalTrials.gov on 2026-08-30.

2026-04-07
Amendment Study Status, Oversight, Contacts/Locations v7
2025-09-11
Amendment Study Identification, Study Status, Arms and Interventions, Eligibility, Contacts/Locations v6
2024-11-22
Amendment Study Status, Contacts/Locations v5
2024-09-11
Amendment Study Identification, Study Status, Oversight, Eligibility, Contacts/Locations v4
2024-08-09
Amendment Study Status, Contacts/Locations v3
2024-07-26
Amendment Study Status v2
2024-05-30
Amendment Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
2024-04-11
Original filing
Trial Details
NCT Number NCT06362369
Lead Sponsor 7 Hills Pharma, LLC
Conditions Advanced Cancer, Advanced Solid Tumor, Melanoma, Metastasis, Pleural Mesothelioma, Renal Cell Carcinoma, MSI-High, Mismatch Repair Deficiency +10 more
Enrollment 126 participants
Start Date 2024-08-23
Primary Completion 2027-12-31 (estimated)
Study Completion 2028-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-13