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

NCT06362369 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 7HP-111
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 5

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

Conditions

Advanced Cancer; Advanced Solid Tumor; Melanoma; Metastasis; Renal Cell Carcinoma; MSI-High; Mismatch Repair Deficiency; Colorectal Cancer; Renal Cell Cancer; Kidney Cancer; Skin Cancer; Non Small Cell Lung Cancer; NSCLC; ALK Genomic Tumor Aberrations; Pleural Mesothelioma; Hepatocellular Carcinoma; Hepatocellular Cancer; Anaplastic Lymphoma Kinase Genomic Tumor Aberrations

Keywords

Phase 1; Phase 1b; 7 Hills Pharma

Outcome Measures

Primary Outcomes (3)

• Number of participants treated with Alintegimod monotherapy with treatment related adverse events as assessed by CTCAEv5.0

  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

  1 year

• Number of participants treated with Alintegimod in combination with treatment related adverse events as assessed by CTCAEv5.0

  To evaluate the safety and tolerability of Alintegimod administered in combination with ipilimumab followed by sequential nivolumab monotherapy, in the number of patients with adverse events as assessed by CTCAE v5.0 and coded by System Organ Class (SOC) using MedDRA coding dictionary

  1 year

• Define RPTDs for Alintegimod

  To define two doses of the Alintegimod + ipilimumab followed by nivolumab cohorts that will be used in the Phase 2a (Part B) study.

  18 months

Secondary Outcomes (6)

• Characterize Pharmacokinetics of Alintegimod monotherapy by measuring Maximum Plasma Concentration (Cmax)

  1 year

• Characterize Pharmacokinetics of Alintegimod monotherapy by measuring Area Under the Curve (AUC)

  1 year

• Characterize Pharmacokinetics of Alintegimod plus ipilimumab by measuring Maximum Plasma Concentration (Cmax)

  1 year

• Characterize Pharmacokinetics of Alintegimod plus ipilimumab by measuring Area Under the Curve (AUC)

  1 year

• Determine Progression Free Survival (PFS) response in patients treated with Alintegimod plus ipilimumab followed by nivolumab using RECIST v1.1 tumor assessment criteria.

  18 months

Study Arms (1)

Dose Escalation - Open Label Phase 1b

EXPERIMENTAL

Alintegimod dose escalation, 4 cohorts Alintegimod monotherapy 1 cycle Alintegimod + Ipilimumab - 4 cycles Nivolumab - 11 cycles

Drug: Alintegimod; Drug: Ipilimumab; Drug: Nivolumab

Interventions

Alintegimod DRUG

Alintegimod will be provided in bottles of 30 softgel capsules for oral administration

Also known as: 7HP349

Dose Escalation - Open Label Phase 1b

Ipilimumab DRUG

Ipilimumab (Yervoy) will be administered via IV

Also known as: Yervoy

Dose Escalation - Open Label Phase 1b

Nivolumab DRUG

Nivolumab (Opdivo) will be administered via IV

Also known as: Opdivo

Dose Escalation - Open Label Phase 1b

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Adult patients (age 18 or older)
• Patient has a histologically confirmed diagnosis of any of the following locally advanced or metastatic solid tumors: melanoma, pleural mesothelioma, renal cell carcinoma, MSI-high or mismatch repair-deficient colorectal cancer, hepatocellular carcinoma, and non-small cell lung cancer with no EGFR or anaplastic lymphoma kinase (ALK) genomic tumor aberrations, or tumor types for which the combination of ipilimumab and nivolumab has been FDA approved. Patients may have received treatment with anti PD-1/PD-L1.
• ANC ≥ 1000/µL without use of G-CSF, Hgb ≥ 9 g/dL without required blood transfusion for at least 5 days prior to pretreatment baseline, and platelet count ≥ 75,000/µL without transfusions for at least 5 days prior to pretreatment baseline.
• ECOG performance status of 0 or 1.
• Has a life expectancy of \> 12 weeks.
• Renal and hepatic function requirements:
• a. Renal function with either an eCrCL ≥ 60 mL/min (modified Cockcroft-Gault) or eGFR ≥ 60 mL/min/1.73 m2 (using MDRD or CKD-EPI or similar equations).
• b. Hepatic function with ALT/AST ≤ 3 x ULN, total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert Syndrome). If patients have hepatic metastases, then AST/ALT≤ 5 x ULN will be allowed.
• All Grade 3 AEs related to prior therapies have returned to Grade 1 or resolved to baseline (this includes with appropriate therapy in the case of thyroid dysfunction).
• All patients must have measurable disease by applicable RECIST criteria.
• Willing to allow blood samples to be used for research.
• Patients must not have received prior anticancer therapy or radiation therapy within the 3 weeks and must not have undergone major surgery within 4 weeks prior to initiation of treatment on protocol. Palliative radiation therapy is allowed. For small molecules (MW \< 0.9 kDA), the washout period is 3 weeks or 5 half-lives, whatever comes first.
• Active brain metastasis or leptomeningeal disease. Patients with treated brain metastasis must have stable disease, evidenced by MRI brain imaging for at least 4 weeks, and the patient must have been off steroids for at least 2 weeks prior to first dose of study drug.
• Previous episodes of ≥ Grade 3 (G3) immune-related toxicity that includes G3 colitis, G3 pneumonitis, G3 skin rash, G3 increase in liver enzymes (with the exception of symptoms that in the opinion of the investigator will not compromise the patients' safety on the trial. Patients with stable endocrinological AEs (e.g., hypothyroidism, adrenal insufficiency, hypopituitarism, or diabetes mellitus) are allowed.
• Persistent toxicity of NCI CTCAE version 5 Grade \> 1 severity that is related to prior therapy.

Sponsors & Collaborators

• 7 Hills Pharma, LLC: lead

Study Sites (5)

University of Colorado Cancer Center

Aurora, Colorado, 84005, United States

RECRUITING

Florida Cancer Specialists

Lake Mary, Florida, 32746, United States

COMPLETED

Dartmouth Hitchcock

Lebanon, New Hampshire, 03756, United States

RECRUITING

Brown University Health Cancer Institute

Providence, Rhode Island, 02906, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Melanoma; Neoplasm Metastasis; Mesothelioma, Malignant; Carcinoma, Renal Cell; Turcot syndrome; Colorectal Neoplasms; Carcinoma, Hepatocellular; Liver Neoplasms; Kidney Neoplasms; Skin Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Ipilimumab; Nivolumab

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mesothelioma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms, Mesothelial; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Pleural Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Urologic Neoplasms; Urogenital Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Liver Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Lionel Lewis, MA, MB.Bch, MD

  7 Hills Pharma

  STUDY CHAIR

Central Study Contacts

Sr. Director Clinical Affairs

CONTACT

1.210.279.1998; nicole@7hillspharma.com

VP Clinical Affairs and Regulatory

CONTACT

6892623575; bill@7hillspharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Phase 1b - Open Label
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: April 12, 2024
• Study Start: August 23, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (5)