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NCT06362369 · ClinicalTrials.gov registry record · Phase 1
A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy
A Phase 1 study of Colorectal Cancer and Melanoma, sponsored by 7 Hills Pharma.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 126
- Enrollment target
- 4
- Study locations
NCT06362369: Recruiting Phase 1 study of Colorectal Cancer and Melanoma, sponsored by 7 Hills Pharma.
NCT06362369 is a Phase 1 study of Colorectal Cancer and Melanoma that is actively recruiting participants, run by 7 Hills Pharma. The registered enrollment target is 126 participants, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (92% lower). The trial reports 4 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06362369, a Phase 1 study of Colorectal Cancer and Melanoma, is actively recruiting participants, sponsored by 7 Hills Pharma.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 126 participants
- Enrollment target
- 4
- Study locations
Study 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
Primary Outcome
To evaluate the safety and tolerability of Alintegimod administered as monotherapy, in the patients with adverse events as assessed by CTCAE v5.0 and coded by System Organ Class (SOC) using MedDRA coding dictionary
Conditions Studied
Interventions
- DRUG Nivolumab
- DRUG Ipilimumab
- DRUG Alintegimod
Study Locations (4)
Florida
- Florida Cancer Specialists - Lake Mary
New Hampshire
- Dartmouth Hitchcock - Lebanon
Rhode Island
- Brown University Health Cancer Institute - Providence
Texas
- MD Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2024-08-23 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 1 |
What NCT06362369 shows while recruiting
NCT06362369 is an interventional study that assigns participants to a tested intervention. The registered 126 participants enrollment target is mid-sized for trials with a published cap, below the 1,544-participant average among 381 other Colorectal Cancer trials with a reported enrollment target (92% lower).
The record links to 10 conditions, with Colorectal Cancer appearing as the primary indexed condition, and to 3 interventions - of which Nivolumab is the first listed.
NCT06362369 reports a single indexed study location in Florida, New Hampshire, Rhode Island.
Frequently Asked Questions
What is clinical trial NCT06362369 about?
NCT06362369 is a clinical study titled "A Study of Oral 7HP349 (Alintegimod) in Combination With Ipilimumab Followed by Nivolumab Monotherapy". 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 nea...
What is the current status of trial NCT06362369?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 126 participants. The study started on 2024-08-23. Estimated completion is 2028-12-31.
What conditions does trial NCT06362369 study?
This clinical trial studies the following conditions: Colorectal Cancer, Melanoma, Advanced Solid Tumor, Hepatocellular Carcinoma, Advanced Cancer.
What interventions are being tested in trial NCT06362369?
The interventions under investigation include: Nivolumab (DRUG), Ipilimumab (DRUG), Alintegimod (DRUG).
Who is sponsoring clinical trial NCT06362369?
This trial is sponsored by 7 Hills Pharma, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06362369 being conducted?
This trial has 4 study locations across Florida, New Hampshire, Rhode Island, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06362369's enrollment target sits among peer trials
126 197th of 381 higher than 185 of 381 other Colorectal Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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