Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Blood and Lymph Conditions

Immune System Diseases

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Neoplasm Metastasis

Carcinoma, Hepatocellular

Lymphoma

Melanoma

Carcinoma, Renal Cell

Liver Neoplasms

Mesothelioma

Mesothelioma, Malignant

Skin Neoplasms

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Adenocarcinoma

Liver Diseases

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Adenoma

Neoplasms, Mesothelial

Lymphosarcoma

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Malignant Mesothelioma

Turcot Syndrome

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Ipilimumab

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Alintegimod dose escalation, 3 cohorts Alintegimod monotherapy 1 cycle Alintegimod + Ipilimumab - 4 cycles Nivolumab - 11 cycles

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

Alintegimod

Ipilimumab (Yervoy) will be administered via IV

Nivolumab (Opdivo) will be administered via IV

Sr. Director Clinical Affairs

William Schary, PhD

Study Coordinator

Alexander Philipovskiy, MD, PhD

Konstantin H Dragnev, MD

Apostolia-Maria Tsimberidou, MD, PhD

Lionel Lewis, MA, MB.Bch, MD

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

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.

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 Anti-PD-1-Resistant Locally Advanced or Metastatic Cancers

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

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

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

To characterize the pharmacokinetics of Cmax of Alintegimod monotherapy.

To characterize the pharmacokinetics of AUC of Alintegimod monotherapy.

To characterize the pharmacokinetics of Cmax of Alintegimod in combination with ipilimumab.

To characterize the pharmacokinetics of AUC of Alintegimod in combination with ipilimumab.

To assess the progression-free survival of patients treated with Alintegimod in combination with ipilimumab followed by nivolumab monotherapy, using RECIST v1.1 assessment for progression.

To assess the overall response rate of patients treated with Alintegimod in combination with ipilimumab followed by nivolumab monotherapy, using RECIST v1.1 assessment for progression.

7 Hills Pharma, LLC

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