Trial Title:
Study of CHS-114 in Participants With Advanced Solid Tumors
NCT ID:
NCT05635643
Condition:
Advanced Solid Tumor
Head and Neck Squamous Cell Carcinoma
Conditions: Official terms:
Squamous Cell Carcinoma of Head and Neck
Conditions: Keywords:
metastatic solid tumors
advanced solid tumors
Phase 1
SRF114
CCR8
safety
efficacy
immunotherapy
cancer
immuno-oncology
CHS-114
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CHS-114
Description:
CHS-114
Arm group label:
Arm 1a: CHS-114 Dose Escalation
Arm group label:
Arm 1b: CHS-114 Dose Expansion
Arm group label:
Arm 2: CHS-114 + toripalimab Dose Expansion
Intervention type:
Drug
Intervention name:
toripaliamab
Description:
toripalimab-tpzi
Arm group label:
Arm 2: CHS-114 + toripalimab Dose Expansion
Other name:
Loqtorzi
Summary:
This is a Phase 1, open-label, first-in-human, dose-escalation and expansion study of
SRF114, a monoclonal antibody that targets CCR8, as a monotherapy in patients with solid
tumors.
Detailed description:
This is a Phase 1, open-label, first-in-human, dose-escalation and expansion study of
CHS-114, a monoclonal antibody that targets CCR8, as a monotherapy in participants with
advanced solid tumors, that will be conducted in 3 parts:
- Arm 1a: CHS-114 monotherapy dose-escalation portion of the study will enroll
approximately 25 participants with advanced solid tumors.
- Arm 1b: CHS-114 monotherapy expansion cohort(s) will evaluate the safety, efficacy,
tolerability, pharmacokinetics, and pharmacodynamics of CHS-114 in indication
specific cohort(s). Up to approximately 10 participants will be enrolled.
- Arm 2: CHS-114 + toripalimab combination dose-escalation portion of the study will
evaluate the safety, efficacy, tolerability, pharmacokinetics, and pharmacodynamics
of CHS-114 in combination with toripalimab in indication specific cohort(s). Up to
approximately 6-12 participants will be enrolled.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria - Arms 1a, 1b, and 2
- Participants must be ≥ 18 years of age.
- For Arm 1a only, 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 the judgment of the Investigator).
- At least 1 measurable lesion per RECIST 1.1.
- Lesions previously treated with radiation or other forms of locoregional therapy
must show radiographic evidence of disease progression to be used as a target
lesion.
- Washout period from the last dose of previous anticancer therapy (chemotherapy,
biologic, or other investigational agent) to the initiation of study drug must be >
5 times the half-life of the agent or > 21 days (whichever is shorter).
- Resolution of non-immune-related AEs secondary to prior anticancer therapy
(excluding alopecia and peripheral neuropathy) to ≤ Grade 1 per NCI-CTCAE version
5.0 or higher, and complete resolution of immune-related AEs secondary to prior
checkpoint inhibitor therapy.
- Serum creatinine clearance ≥ 30 mL/min per Cockcroft-Gault formula.
- Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN if elevated because of Gilbert's syndrome and
≤ 2 × ULN for patients with hepatocellular carcinoma [HCC] or patients with known
liver metastases).
- Aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and
alanine aminotransferase/serum glutamic pyruvic transaminase (ALT/SGPT) < 2.5 × ULN
or < 5 × ULN for patients with known liver metastases.
- Adequate hematologic function, defined as absolute neutrophil count ≥ 1.0 × 109/L,
hemoglobin ≥ 9.0 g/dL, and platelet count ≥ 75 × 109/L.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
- Ejection fraction ≥ 50%, as measured by echocardiogram, multigated acquisition scan,
nuclear stress test, or equivalent modality.
- Willingness of male and female patients who are not surgically sterile or
postmenopausal to use medically acceptable methods of birth control for the duration
of the study treatment period, including 90 days after the last dose of CHS-114, 4
months after the last dose of toripalimab; male patients must refrain from donating
sperm during this period. Sexually active men, and women using oral contraceptive
pills, should also use barrier contraception. Azoospermic male patients and WCBP who
are continuously not heterosexually active are exempt from contraceptive
requirements.
Additional Inclusion Criteria - Arms 1b and 2 only
- Histologically or cytologically confirmed advanced or metastatic HNSCC that has
progressed during or after a platinum-based chemotherapy and/or a programmed cell
death receptor (PD)-1 or PD ligand 1 (PD-L1) targeting agent (separately or in
combination therapy).
- Metastatic or locoregionally recurrent HNSCC malignancy that is incurable by surgery
or radiotherapy.
- Arm 1b only, participants must have tumor tissue that is accessible for pretreatment
and on-treatment tumor biopsy in the opinion of the Investigator and be willing and
consent to undergo pretreatment and on-treatment biopsies per protocol.
Key Exclusion Criteria - Arms 1a, 1b, and 2
- Previously received an anti-CCR8 antibody or anti-CCR8 targeted therapy.
- History of Grade 4 allergic or anaphylactic reaction to any monoclonal antibody
therapy or any excipient in the study drugs.
- Major surgery within 4 weeks prior to Screening.
- Unstable or severe uncontrolled medical condition (eg, unstable cardiac function,
unstable pulmonary condition including pneumonitis and/or interstitial lung disease,
uncontrolled diabetes, symptomatic fistula) 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.
Additional Exclusion Criteria - Arms 1b and 2 only
- Received > 4 prior systemic regimens for advanced/metastatic disease.
- Nasopharyngeal carcinoma or nasal cavity malignancies other than HNSCC (eg,
adenocarcinoma and variants, neuroendocrine tumors, mucosal melanoma).
- Receiving chronic anti-coagulation therapy (eg, warfarin, enoxaparin) that cannot be
safely discontinued temporarily for the required biopsies (only for patients who
provide tumor biopsies).
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Stanford Cancer Center
Address:
City:
Palo Alto
Zip:
94305
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elizabeth Winters
Phone:
650-723-6372
Email:
ewinters@stanford.edu
Investigator:
Last name:
A. Dimitrios Colevas, MD
Email:
Principal Investigator
Facility:
Name:
Emory Winship Cancer Institute
Address:
City:
Atlanta
Zip:
30308
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mosope Oyewole
Phone:
404-778-5351
Email:
mosope.desayo.oyewole@emory.edu
Investigator:
Last name:
Nabil F Saba, MD
Email:
Principal Investigator
Facility:
Name:
University of Louisville
Address:
City:
Louisville
Zip:
40202
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Stacy
Phone:
502-217-5244
Email:
jennifer.stacy.1@louisville.edu
Investigator:
Last name:
Rebecca Redman, MD
Email:
Principal Investigator
Facility:
Name:
University of Michigan
Address:
City:
Ann Arbor
Zip:
48104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Megan Hull
Phone:
734-232-2561
Email:
meghull@med.umich.edu
Investigator:
Last name:
Francis Worden, MD
Email:
Principal Investigator
Facility:
Name:
Barbara Ann Karmanos Cancer Institute - Karmanos Cancer Center
Address:
City:
Detroit
Zip:
48201
Country:
United States
Status:
Recruiting
Contact:
Last name:
Supraja Chalasani
Phone:
313-576-9732
Email:
chalasas@karmanos.org
Investigator:
Last name:
Ammar Sukari, MD
Email:
Principal Investigator
Facility:
Name:
Washington University
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Samuel Williams
Phone:
314-747-2626
Email:
wsamuel@wustl.edu
Contact backup:
Last name:
Douglas Adkins, MD
Phone:
314.747.2626
Email:
dadkins@wustl.edu
Investigator:
Last name:
Douglas Adkins, MD
Email:
Principal Investigator
Facility:
Name:
University of Cincinnati
Address:
City:
Cincinnati
Zip:
45219
Country:
United States
Status:
Recruiting
Contact:
Last name:
Trisha Wise-Draper, MD
Phone:
513-584-7698
Email:
wiseth@ucmail.uc.edu
Investigator:
Last name:
Trisha Wise-Draper, MD
Email:
Principal Investigator
Facility:
Name:
START- San Antonio
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Elizabeth Gomez
Phone:
210-593-5994
Email:
elizabeth.gomez@startsa.com
Investigator:
Last name:
Amita Patnaik, MD
Email:
Principal Investigator
Facility:
Name:
START Mountain
Address:
City:
West Valley City
Zip:
84119
Country:
United States
Status:
Recruiting
Contact:
Last name:
Marianne Herden
Phone:
801-907-4753
Email:
marianne.herndon@startthecure.com
Contact backup:
Last name:
Justin Call, MD
Phone:
801-907-4753
Email:
justin.call@startthecure.com
Investigator:
Last name:
Justin Call, MD
Email:
Principal Investigator
Facility:
Name:
University of Washington/Fred Hutchinson Cancer Center
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ariana Dumenigo Jimenez
Phone:
206-606-7445
Email:
adumenigoj@fredhutch.org
Investigator:
Last name:
Christina Rodriguez, MD
Email:
Principal Investigator
Start date:
December 15, 2022
Completion date:
February 2026
Lead sponsor:
Agency:
Coherus Biosciences, Inc.
Agency class:
Industry
Source:
Coherus Biosciences, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05635643
