Spots Global Cancer Trial Database for A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy

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Trial Identification

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

Official Title: A Phase 1b/2a Multi-Center, Dose Escalation and Reference Regimen-Controlled, Multi-Cohort Study to Determine the Safety and Efficacy of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy in Patients With Anti-PD-1-Resistant Locally Advanced or Metastatic Cancers

Study ID: NCT06362369

Conditions

Mismatch Repair Deficiency

Colorectal Cancer

Hepatocellular Carcinoma

Hepatocellular Cancer

Renal Cell Cancer

Kidney Cancer

Skin Cancer

Non Small Cell Lung Cancer

NSCLC

Anaplastic Lymphoma Kinase Genomic Tumor Aberrations

ALK Genomic Tumor Aberrations

Interventions

Alintegimod

Ipilimumab

Nivolumab

Study Description

Brief Summary: 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

Detailed Description: This Phase study is designed to evaluate the safety, tolerability, and preliminary efficacy of oral Alintegimod (Alintegimod) alone, and then in combination with ipilimumab for, followed by nivolumab monotherapy cycles. All patients will receive nivolumab after completion of treatment with Alintegimod plus ipilimumab combination therapy to continue nivolumab treatment until the end of study (12 months) unless progression or toxicity result in early termination.