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New treatment option for Metastatic Solid Tumor
Official title A Study of CHS-114 (Tagmokitug) in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors
ClinicalTrials.gov ID: NCT06657144
What this study is testing
What is CHS-114?
CHS-114 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for metastatic 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
- The main purpose of this study is to evaluate the safety and preliminary efficacy of CHS-114 in combination with toripalimab and/or other standard of care (SOC) compound(s) in participants with advanced or metastatic solid tumors.
- Phase 1: an early, usually small safety study
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
You may be able to join if
- At least 1 measurable lesion based on RECIST v1.1 as determined by the Investigator.
- Resolved acute effects of any prior therapy to baseline severity or Grade 1 in accordance with National Cancer Institute (NCI)-Common Terminology...
- Histologically or cytologically documented unresectable, locally advanced or metastatic gastric, GEJ, or esophageal adenocarcinoma that is human...
- Progressed during or after first line systemic therapy that includes a platinum and fluoropyrimidine doublet with or without anti-programmed death...
- Consent to provide tumor tissue samples (baseline and on-treatment) is required for enrollment. Cohort B (2L Esophageal Squamous Cell Carcinoma...
You likely can't join if
- History of prior malignancy other than the cancer under study that is progressing or has required active treatment within the past 3 years.
- Symptomatic or untreated central nervous system metastases, including leptomeningeal metastases, requiring concurrent treatment, including but not...
- Major surgery requiring general anesthesia within 28 days prior to the first dose of study treatment, still recovering from prior surgery, or with...
- Prior exposure to anti-C-C motif chemokine receptor 8 (CCR8) antibody.
- History of Grade 4 allergic or anaphylactic reaction to any monoclonal antibody (mAb) therapy or any excipient in the study treatment.
- Active uncontrolled bacterial, fungal, or viral infection including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency...
See the full eligibility criteria
Who can join
- At least 1 measurable lesion based on RECIST v1.1 as determined by the Investigator.
- Resolved acute effects of any prior therapy to baseline severity or Grade 1 in accordance with National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except for adverse events (AEs)...
- Histologically or cytologically documented unresectable, locally advanced or metastatic gastric, GEJ, or esophageal adenocarcinoma that is human epidermal growth factor receptor 2 (HER2) - negative and microsatellite...
- Progressed during or after first line systemic therapy that includes a platinum and fluoropyrimidine doublet with or without anti-programmed death receptor 1 (PD-1)/programmed death ligand 1 (PD-L1)-directed therapy...
- Consent to provide tumor tissue samples (baseline and on-treatment) is required for enrollment. Cohort B (2L Esophageal Squamous Cell Carcinoma [ESCC]) - Specific
- Histologically or cytologically documented unresectable, locally advanced or metastatic ESCC.
- Progressed during or after first line systemic therapy including a doublet of platinum and fluoropyrimidine or paclitaxel with or without anti-PD-1/PD-L1-directed therapy or anti-CTLA-4 and anti-PD-1/PD-L1-directed...
- Consent to provide results from prior PD-L1 IHC assay score by FDA-approved or equivalent PD-L1 IHC diagnostic tests.
- Consent to provide archival tumor tissue sample (baseline) is required for enrolment. Cohort C (1L Esophageal Squamous Cell Carcinoma [ESCC]) - Specific
- Histologically or cytologically documented unresectable, locally advanced or metastatic ESCC.
- Consent to provide baseline tumor tissue is required.
- Consent to provide results from prior PD-L1 IHC assay score by FDA-approved or equivalent PD-L1 IHC diagnostic tests.
- Calculated creatinine clearance ≥60 mL/min. Cohort D, Arms D1 and D2 (4L+ Colorectal Carcinoma [CRC]) - Specific
- Histologically and/or cytologically documented unresectable advanced or metastatic colorectal adenocarcinoma. RAS, BRAF, and microsatellite instability/mismatch repair status for each participant must be documented...
- Participants who have no available therapies with a proven clinical benefit available in the participant's country per investigator. These therapies include the following: fluoropyrimidine, oxaliplatin, irinotecan-based...
- Participants who received oxaliplatin in the adjuvant setting and developed metastatic disease during or within 6 months of completing adjuvant therapy are considered eligible without receiving oxalipatin-based therapy...
- Consent to provide baseline tumor tissue sample is required for enrolment. Key
What rules you out
- History of prior malignancy other than the cancer under study that is progressing or has required active treatment within the past 3 years.
- Symptomatic or untreated central nervous system metastases, including leptomeningeal metastases, requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids.
- Major surgery requiring general anesthesia within 28 days prior to the first dose of study treatment, still recovering from prior surgery, or with surgery scheduled during the study.
- Prior exposure to anti-C-C motif chemokine receptor 8 (CCR8) antibody.
- History of Grade 4 allergic or anaphylactic reaction to any monoclonal antibody (mAb) therapy or any excipient in the study treatment.
- Active uncontrolled bacterial, fungal, or viral infection including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
- Any condition that, in the opinion of the Investigator or Sponsor, would interfere with the interpretation of study results. Cohort A (2L Gastric, Gastro-esophageal-junction [GEJ], Esophageal Adenocarcinoma [EAC])...
- Received ≥ 2 prior systemic anticancer therapies for advanced or metastatic disease.
- Participants at high risk for developing esophageal fistula by clinical assessment or imaging, such as prior history or associated symptoms of esophageal fistula or T4 classification assessed by endoscopic ultrasound...
- Received ≥ 2 prior systemic anticancer therapies for advanced or metastatic disease.
- Participants at high risk for developing esophageal fistula by clinical assessment or imaging, such as prior history or associated symptoms of esophageal fistula or T4 classification assessed by endoscopic ultrasound...
- Received ≥ 1 prior systemic anticancer therapies for advanced or metastatic disease.
- Participants who progressed during or within 6 months following the last dose of neoadjuvant, or perioperative therapy with curative intent.
- Participants at high risk for developing esophageal fistula by clinical assessment or imaging, such as prior history or associated symptoms of esophageal fistula or T4 classification assessed by endoscopic ultrasound...
- Known dihydropyrimidine dehydrogenase deficiency or thymidine synthase gene polymorphism predisposing the participant to 5-FU toxicity.
- Known allergies to 5-FU or cisplatin. Note: Other protocol-specified inclusion/exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Tucson, Arizona, United States
- Duarte, California, United States
- Aurora, Colorado, United States
- Atlanta, Georgia, United States
- New Orleans, Louisiana, United States
- Detroit, Michigan, United States
- Las Vegas, Nevada, United States
- Santa Fe, New Mexico, United States
- Lake Success, New York, United States
- New York, New York, United States
- Pittsburgh, Pennsylvania, United States
- Greenville, South Carolina, United States
- Nashville, Tennessee, United States
- Austin, Texas, United States
- San Antonio, Texas, United States
- Salt Lake City, Utah, United States
- West Valley City, Utah, United States
- Fairfax, Virginia, United States
- Norfolk, Virginia, United States
- Chang-hua, Taiwan
+ 4 more site(s).
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. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tucson, Arizona, United States; Duarte, California, United States; Aurora, Colorado, United States; Atlanta, Georgia, United States; New Orleans, Louisiana, United States; Detroit, Michigan, United States and 18 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.