Phase 1/2Recruiting
A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy
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 Locally Advanced or Metastatic Cancers Following One or More Prior Therapies
- Sponsor
- 7 Hills Pharma, LLC (Industry)
- Enrollment
- 126 planned
- Conditions
- Advanced Cancer; Advanced Solid Tumor; Melanoma; Metastasis; Pleural Mesothelioma; Renal Cell Carcinoma; MSI-High; Mismatch Repair Deficiency; Colorectal Cancer; Hepatocellular Carcinoma; Hepatocellular Cancer; Renal Cell Cancer
- Interventions
- Alintegimod; Ipilimumab; Nivolumab
- Ages
- adults, older adults
- Registry
- NCT06362369
Full record on ClinicalTrials.gov
From the registry
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
Primary outcomes
- Number of participants treated with Alintegimod monotherapy with treatment related adverse events as assessed by CTCAEv5.0
- Number of participants treated with Alintegimod in combination with treatment related adverse events as assessed by CTCAEv5.0
- Define RPTDs for Alintegimod
History
Study completion expected
Primary completion expected
Last registry update
Started
Registered