RecruitingPhase 1

A Study of CHS-114 (Tagmokitug) in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors

A Phase 1B, Multicenter, Open-Label Study of the Safety and Efficacy of CHS-114 in Combination With Toripalimab With or Without Other Treatments in Participants With Advanced or Metastatic Solid Tumors (TREGCHECK 102)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests CHS-114 (tagmokitug) with toripalimab and/or other standard cancer treatments. It checks safety and early signs of how well treatment works in people with solid tumors that are advanced or have spread.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have at least one tumor that the study doctor can measure.
  • Side effects from past treatment must be mild or back to their earlier level, unless the doctor decides they pose no safety risk.
  • Group A: Have stomach or food pipe adenocarcinoma, a gland-cell cancer, that cannot be removed by surgery and is advanced or has spread. Tests must show HER2-negative and MSS/pMMR cancer.
  • Group A: Cancer must have worsened during or after a first treatment with platinum and fluoropyrimidine chemotherapy, with or without immune treatment. Provide tumor samples before and during study treatment.
  • Group B: Have advanced or spreading squamous cell cancer of the food pipe that cannot be removed by surgery. Cancer must have worsened after one of the listed first treatments. Provide stored tumor tissue and past PD-L1 test results.
  • Group C: Have advanced or spreading squamous cell cancer of the food pipe that cannot be removed by surgery. Provide tumor tissue and past PD-L1 test results. Kidney filtering must be at least 60 mL/min.
  • Group D: Have advanced or spreading colon or rectal gland-cell cancer that cannot be removed by surgery. Provide tumor tissue and records of required tumor gene and DNA-repair tests.
  • Group D: Have no treatment with proven benefit still available in your country, as judged by the study doctor.

Who can't join

  • Another cancer that is getting worse or has needed active treatment in the past 3 years.
  • Cancer spread to the brain, spinal cord, or their lining that causes symptoms or is untreated and needs treatment.
  • Major surgery under general anesthesia within 28 days before study treatment, ongoing recovery from surgery, or surgery planned during the study.
  • Past treatment with an anti-CCR8 antibody, or a life-threatening allergic reaction to an antibody treatment or an ingredient in the study treatment.
  • An active, uncontrolled bacterial, fungal, or viral infection, including hepatitis B, hepatitis C, known HIV, or AIDS-related illness.
  • Groups A, B, and C: High risk of a fistula, an abnormal opening in the food pipe. Groups A and B also exclude people who had two or more treatments that reach the whole body for advanced or spreading cancer.
  • Group C: Any past treatment that reaches the whole body for advanced or spreading cancer, or cancer that worsened during or within 6 months after treatment around surgery meant to cure it.
  • Group C: Allergy to 5-FU or cisplatin, or certain known enzyme or gene changes that raise the risk of harm from 5-FU chemotherapy.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: * 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) not constituting a safety risk per Investigator judgement. Cohort A (2L Gastric, Gastro-esophageal-junction \[GEJ\], Esophageal Adenocarcinoma \[EAC\]) Specific Inclusion Criteria: * 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 stable (MSS)/proficient mismatch repair (pMMR). * 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 (that is, in the second line setting). * Consent to provide tumor tissue samples (baseline and on-treatment) is required for enrollment. Cohort B (2L Esophageal Squamous Cell Carcinoma \[ESCC\]) - Specific Inclusion Criteria: * 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 combination therapy. * 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 Inclusion Criteria: * 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 Inclusion Criteria: * 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, according to country level guidelines. * 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 chemotherapy, anti-VEGF biological therapy (eg, bevacizumab, aflibercept, ramucirumab), an anti-EGFR therapy (eg, cetuximab, panitumumab) if RAS wildtype unless right-sided, either trifluridine/tipiracil, fruqintinib or regorafenib, and a BRAF inhibitor (ie, encorafenib) in BRAF V600E mutant). * 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 in the metastatic setting. * Consent to provide baseline tumor tissue sample is required for enrolment. Key Exclusion Criteria: * 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 \[EAC\]) Specific Exclusion Criteria: * 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 (EUS). Cohort B (2L Esophageal Squamous Cell Carcinoma \[ESCC\]) - Specific Exclusion Criteria: * 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 (EUS). Cohort C (1L Esophageal Squamous Cell Carcinoma \[ESCC\]) - Specific Exclusion Criteria: * 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 (EUS). * 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.

Study sites (20)

AZ

CA

CO

GA

LA

MI

NM

NV

NY

PA

SC

TN

TX

UT

VA