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New treatment option for Advanced Solid Tumor
Official title Study of CHS-114 in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT05635643
What this study is testing
What is CHS-114?
CHS-114 is an investigational medicine, being studied as a potential treatment for advanced solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Key - Arms 1a, 1b, 2, and 3
- 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...
- 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...
You likely can't join if
- Arms 1a, 1b, 2, and 3
- 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...
- Received \> 4 prior systemic regimens for advanced/metastatic disease.
See the full eligibility criteria
- Key - Arms 1a, 1b, 2, and 3
- 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.
- For 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...
- 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...
- Serum creatinine clearance ≥ 30 mL/min per Cockcroft-Gault formula.
- Total bilirubin ≤ 1.5 × ULN (≤ 3 × ULN if elevated because of liver metastases or documented Gilbert's syndrome).
- 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...
- Adequate hematologic function, defined as absolute neutrophil count ≥ 1.0 × 10\^9/L, hemoglobin ≥ 8.0 g/dL, and platelet count ≥ 75 × 10\^9/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...
- 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...
- 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...
- Histologically 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...
- Participants 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...
- Metastatic or locoregionally recurrent HNSCC malignancy that is incurable by surgery or radiotherapy.
- Consent to provide HPV status assessed by p16 and results from baseline PD-L1 IHC assay score.
- Consent to provide tumor tissue samples is required for enrollment. Key
- Arms 1a, 1b, 2, and 3
- 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...
- 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). Additional Exclusion...
- Received ≥ 2 prior systemic regimens for advanced/metastatic disease.
The study team makes the final eligibility decision.
Where it's taking place
- Newport Beach, California, United States
- Oxnard, California, United States
- Palo Alto, California, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Hinsdale, Illinois, United States
- Louisville, Kentucky, United States
- Baltimore, Maryland, United States
- Ann Arbor, Michigan, United States
- Detroit, Michigan, United States
- St Louis, Missouri, United States
- Cincinnati, Ohio, United States
- Nashville, Tennessee, United States
- San Antonio, Texas, United States
- West Valley City, Utah, United States
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newport Beach, California, United States; Oxnard, California, United States; Palo Alto, California, United States; Orlando, Florida, United States; Atlanta, Georgia, United States; Hinsdale, Illinois, United States and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.