COMPLETED

Study of CHS-388 (Formerly Known as SRF388) in Patients With Advanced Solid Tumors

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Conditions

Advanced Solid TumorClear Cell Renal Cell CarcinomaHepatocellular CarcinomaNon-small Cell Lung Cancermetastatic solid tumorsadvanced solid tumorsPhase 1CHS-388IL-27safetyefficacyimmunotherapycancerimmuno-oncologykidney cancerrenal cell carcinomaliver cancerpembrolizumabPD-1toripalimabSRF388

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase 1/1b, open-label, first-in-human, dose-escalation and expansion study of CHS-388, a monoclonal antibody that targets IL-27, as a monotherapy and in combination in patients with solid tumors.

Official Title

A Phase 1/1b Study of CHS-388 (Formerly Known as SRF388) in Patients With Advanced Solid Tumors

Quick Facts

Study Start:2020-04-22
Study Completion:2025-06-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04374877

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥ 18 years of age
  2. * Locally advanced or metastatic (Stage IV) solid tumor that has progressed during or after standard therapy, and for whom no available therapies are appropriate (based on investigator judgment)
  3. * Patients in Part B with advanced or metastatic ccRCC, HCC, or NSCLC must have at least 1 measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
  4. * Patients with HCC in Part B must have at least 1 measurable target lesion according to modified RECIST (mRECIST)
  5. * Patients with HCC must have unresectable disease, Barcelona Clinic Liver Cancer (BCLC1) Stage B (not eligible for transcatheter arterial chemoembolization \[TACE\]) or Stage C
  6. * For patients in Part B with ccRCC, demonstrated progressive disease (PD) during or after the most recent treatment regimen. Prior treatment history must include progression during or after treatment with regimen(s) that have included a vascular endothelial growth factor (VEGF)-targeted agent and an immune checkpoint inhibitor. Patients who did not progress on but discontinued the VEGF-targeted agent for toxicity or intolerability are permitted.
  7. * For patients in Part B with HCC, demonstrated PD during or after the most recent treatment regimen. Prior treatment history must include progression during or after treatment with a VEGF-targeted agent. Patients who did not progress on but discontinued the VEGF-targeted agent for toxicity or intolerability are permitted.
  8. * For Part B patients in the tumor biopsy subsets only, must have tumor tissue that is accessible for pretreatment and on-treatment tumor biopsy in the opinion of the Investigator and be willing to undergo pretreatment and on-treatment biopsies per protocol
  9. * Serum creatinine clearance ≥ 30 mL/min per Cockcroft-Gault formula or serum creatinine ≤ 2.0 x the upper limit of normal (ULN)
  10. * Total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN if elevated because of Gilbert's syndrome and ≤ 2 x ULN for patients with HCC or patients with known liver metastases)
  11. * Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) \< 2.5 x ULN (\< 5 x ULN if liver metastasis or for patients with HCC)
  12. * For patients with HCC, Child-Pugh class A or B7 with a serum albumin ≥ 2.8 g/dL (≥ 28 g/L)
  13. * Adequate hematologic function, defined as absolute neutrophil count (ANC) ≥ 1.0 x 109/L, hemoglobin ≥ 9.0 g/dL, and platelet count ≥ 100 x 109/L. For patients with HCC, platelet count ≥ 75 x 109/L without transfusion
  14. * Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  15. * Patients with NSCLC must have histologically confirmed locally advanced and/or metastatic Stage IV NSCLC
  16. * Patients with NSCLC must have demonstrated progressive disease during or after the most recent treatment regimen
  1. * Previously received an anti-IL-27 antibody or anti-IL-27 targeted therapy
  2. * For patients in Part B with renal cell carcinoma (RCC), non-clear cell RCC histology
  3. * For patients with HCC, known fibrolamellar or mixed hepatocellular cholangiocarcinoma
  4. * History of Grade 4 allergic or anaphylactic reaction to any monoclonal antibody therapy or any excipient in the study drugs
  5. * Major surgery within 4 weeks prior to Screening
  6. * Unstable or severe uncontrolled medical condition (eg, unstable cardiac function, unstable pulmonary condition including pneumonitis and/or interstitial lung disease, uncontrolled diabetes) or any important medical illness or abnormal laboratory finding that would, in the Investigator's judgment, increase the risk to the patient associated with his or her participation in the study

Contacts and Locations

Principal Investigator

Koho Iizuka, MD
STUDY_CHAIR
Coherus BioSciences

Study Locations (Sites)

City of Hope
Duarte, California, 91010
United States
University of Southern California (USC) - Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
UCSF Medical Center - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, 94143
United States
University of Miami Leonard M. Miller School of Medicine (UMMSM)
Miami, Florida, 33136
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
United States
University of Michigan Health System (UMHS)
Ann Arbor, Michigan, 48109
United States
Washington University School of Medicine - St. Louis
St Louis, Missouri, 63110
United States
Roswell Park
Buffalo, New York, 14263
United States
Icahn School of Medicine at Mount Sinai (ISMMS) - The Mount Sinai Hospital (MSH)
New York, New York, 10029
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
University of Oklahoma Health Sciences Center (OUHSC) - Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104
United States
University of Pittsburgh Medical Center (UPMC) - Hillman Cancer Center (University of Pittsburgh Cancer Institute (UPCI))
Pittsburgh, Pennsylvania, 15232
United States
Vanderbilt University Medical Center (VUMC)
Nashville, Tennessee, 37232
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
The University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030
United States
South Texas Accelerated Research Therapeutics
San Antonio, Texas, 78229
United States
University of Washington
Seattle, Washington, 98195
United States

Collaborators and Investigators

Sponsor: Coherus Oncology, Inc.

  • Koho Iizuka, MD, STUDY_CHAIR, Coherus BioSciences

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-04-22
Study Completion Date2025-06-05

Study Record Updates

Study Start Date2020-04-22
Study Completion Date2025-06-05

Terms related to this study

Keywords Provided by Researchers

  • metastatic solid tumors
  • advanced solid tumors
  • Phase 1
  • CHS-388
  • IL-27
  • safety
  • efficacy
  • immunotherapy
  • cancer
  • immuno-oncology
  • kidney cancer
  • renal cell carcinoma
  • liver cancer
  • hepatocellular carcinoma
  • non-small cell lung cancer
  • pembrolizumab
  • PD-1
  • toripalimab
  • SRF388

Additional Relevant MeSH Terms

  • Advanced Solid Tumor
  • Clear Cell Renal Cell Carcinoma
  • Hepatocellular Carcinoma
  • Non-small Cell Lung Cancer