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Back|NCT05635643Recruiting
Official Title

A Phase 1 Study of CHS-114 in Participants With Advanced Solid Tumors

Phase
Phase 1
Sponsor
Coherus Oncology, Inc.
Enrollment
87
Timeline
Dec 2022 → Feb 2026
About This Study

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 patients with solid tumors.

Eligibility Criteria

Inclusion Criteria

  • 1Participants must be ≥ 18 years of age.
  • 2For 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).
  • 3At least 1 measurable lesion per RECIST 1.1.
  • 4Lesions previously treated with radiation or other forms of locoregional therapy must show radiographic evidence of disease progression to be used as a target lesion.
  • 5For Arms 1a, 1b, and 2 only, 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).
  • 6Resolution 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.
  • 7Serum creatinine clearance ≥ 30 mL/min per Cockcroft-Gault formula.
  • 8Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN if elevated because of liver metastases or documented Gilbert's syndrome).
  • 9Aspartate 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.
  • 10Adequate hematologic function, defined as absolute neutrophil count ≥ 1.0 × 10\^9/L, hemoglobin ≥ 8.0 g/dL, and platelet count ≥ 75 × 10\^9/L.
  • 11Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
  • 12Ejection fraction ≥ 50%, as measured by echocardiogram, multigated acquisition scan, nuclear stress test, or equivalent modality.
  • 13Willingness 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 women of childbearing potential who are continuously not heterosexually active are exempt from contraceptive requirements.
  • 14Histologically 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).
  • 15Metastatic or locoregionally recurrent HNSCC malignancy that is incurable by surgery or radiotherapy.
  • 16Arm 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.
  • 17Histologically or cytologically confirmed locally advanced or metastatic HNSCC (primary tumor location of oral cavity, oropharynx, hypopharynx, or larynx). Participants may not have a primary tumor site of nasopharynx (any histology).
  • 18Participants should have been treated with anti-PD-1/PD-L1-directed systemic therapy for incurable recurrent, advanced, or metastatic disease and experienced progressive disease. targeting agent (separately or in combination therapy).
  • 19Metastatic or locoregionally recurrent HNSCC malignancy that is incurable by surgery or radiotherapy.
  • 20Consent to provide HPV status assessed by p16 and results from baseline PD-L1 IHC assay score.
  • 21Consent to provide tumor tissue samples is required for enrollment.

Exclusion Criteria

  • 1Previously received an anti-CCR8 antibody or anti-CCR8 targeted therapy.
  • 2History of Grade 4 allergic or anaphylactic reaction to any monoclonal antibody therapy or any excipient in the study drugs.
  • 3Major surgery within 4 weeks prior to Screening.
  • 4Unstable 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.
  • 5Received \> 4 prior systemic regimens for advanced/metastatic disease.
  • 6Nasopharyngeal carcinoma or nasal cavity malignancies other than HNSCC (eg, adenocarcinoma and variants, neuroendocrine tumors, mucosal melanoma).
  • 7Receiving chronic anti-coagulation therapy (eg, warfarin, enoxaparin) that cannot be safely discontinued temporarily for the required biopsies (only for patients who provide tumor biopsies).
  • 8Received ≥ 2 prior systemic regimens for advanced/metastatic disease.

Locations

16 sites participating in this study

Emory Winship Cancer Institute

Atlanta, Georgia 30308

Recruiting

Nabil F Saba, MD

Hoag Memorial Hospital

Newport Beach, California 92663

Recruiting

Alain Mita, MD

FOMAT Medical Research

Oxnard, California 93030

Recruiting

Nawazish Khan, MD

Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →