NCT06362369 is a Phase 1, PHASE2 clinical trial of Alintegimod in Advanced Cancer, sponsored by 7 Hills Pharma, LLC.

Who is sponsoring NCT06362369?

NCT06362369 is sponsored by 7 Hills Pharma, LLC.

What drugs are being tested in NCT06362369?

Interventions in NCT06362369: Alintegimod, Ipilimumab, Nivolumab.

What condition does NCT06362369 study?

NCT06362369 studies 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, Kidney Cancer, Skin Cancer, Non Small Cell Lung Cancer, NSCLC, Anaplastic Lymphoma Kinase Genomic Tumor Aberrations, ALK Genomic Tumor Aberrations.

Is NCT06362369 still recruiting?

NCT06362369 is currently recruiting now. Last updated 13 April 2026.

Last reviewed 2026-04-13 · How we verify

NCT06362369

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Recruiting now Phase 1, PHASE2 Last updated 13 April 2026

What this trial tests

Phase 1, PHASE2 trial testing Alintegimod in Advanced Cancer in 126 participants. Currently enrolling.

Timeline

23 August 2024

Primary endpoint
31 December 2027

31 December 2028

Quick facts

Lead sponsor	7 Hills Pharma, LLC
Phase	Phase 1, PHASE2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	126
Start date	23 August 2024
Primary completion	31 December 2027
Estimated completion	31 December 2028
Sites	5 locations across United States

Drugs / interventions tested

Alintegimod — full drug profile →
Ipilimumab — full drug profile →
Nivolumab (nivolumab) — full drug profile →

Conditions studied

Advanced Cancer — all drugs for Advanced Cancer →
Advanced Solid Tumor — all drugs for Advanced Solid Tumor →
Melanoma — all drugs for Melanoma →
Metastasis — all drugs for Metastasis →

Sponsor

7 Hills Pharma, LLC — full company profile →

Who can join

18 and older, any sex, with Advanced Cancer or Advanced Solid Tumor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Focal adhesion in the tumour metastasis: from molecular mechanisms to therapeutic targets.
Liu Z, Zhang X, Ben T, Li M, et al · · 2025 · cited 12× · PMID 40045379 · DOI 10.1186/s40364-025-00745-7
Current and emerging concepts for systemic treatment of metastatic colorectal cancer.
Steup C, Kennel KB, Neurath MF, Fichtner-Feigl S, et al · · 2025 · cited 10× · PMID 41047178 · DOI 10.1136/gutjnl-2025-335412
Interplay of integrins and selectins in metastasis.
Maltseva D, Nersisyan A, Tonevitsky A. · · 2025 · cited 1× · PMID 40327521 · DOI 10.1002/1878-0261.70026
Targeting Tumor Stroma: Current Challenges and Future Directions.
Wang S, Hu H, Zeng W, Qin L, et al · · 2026 · PMID 42125068 · DOI 10.1002/mco2.70763
Emerging Immunotherapy and Antibody-Derived Therapeutics for the Treatment of Advanced Non-Small-Cell Lung Cancer: A Review.
Hou AY, Elantably D, Manochakian R, Velcheti V, et al · · 2026 · PMID 42073614 · DOI 10.3390/cancers18081291

Verify or expand the search:

Other recruiting trials for Advanced Cancer

Currently open trials in the same condition.

NCT07393529 — A Pilot Randomized Controlled Trial of a Social Network Intervention · NA · recruiting
NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss · Phase 1 · recruiting
NCT07246954 — A Chaplain-clinician Led Spiritual Care (PEACE) Intervention on Spiritual/Religious Beliefs Related to Medical Care in P · NA · recruiting
NCT06346197 — Combination of Immune Checkpoint in Locally Advanced or Metastatic MSI/dMMR Esogastric Adenocarcinomas · Phase 3 · recruiting
NCT07147023 — Better Real-time Information on Documentation of Goals of Care for Engagement in Serious Illness Communication · NA · active not recruiting

Other 7 Hills Pharma, LLC trials

Trials by the same sponsor.

NCT04508179 — A Phase 1 SAD and MAD Study of the Safety, Tolerability and PK of 7HP349 in Normal Healthy Male Subjects · Phase 1 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT06362369 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by 7 Hills Pharma, LLC
Last refreshed: 13 April 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06362369.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing