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Protocol NumberCHS-114-102
NCT Number(ClinicalTrials.gov Identfier)NCT06657144
Active

2025-03-31 - 2028-01-31

Phase I

Recruiting10

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

  • Trial Applicant

    MEDPACE TAIWAN LIMITED

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator Chia-Chi Lin Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ming-Huang Chen Division of Hematology & Oncology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Li-Yuan Bai Division of Hematology & Oncology
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chia-Jui Yen
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator HSIN-CHEN LIN Division of General Internal Medicine
Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Meng-Jer Hsieh Division of Hematology & Oncology
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林建良 Division of Hematology & Oncology
Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 蘇迺文 Division of Hematology & Oncology
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 賴冠銘 Division of Hematology & Oncology
CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jaw-Yuan Wang Division of Colorectal Surgery
Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Metastatic Solid Tumor、 Advanced Solid Tumor

Objectives

Groups A, B, C, and D Primary Objectives • Evaluate the safety and tolerability of CHS-114 combined with toripalimab, and the safety and tolerability of Group C combined with standard-of-care chemotherapy. Secondary Objectives • Evaluate the preliminary antitumor activity of CHS-114 combined with toripalimab, and the preliminary antitumor activity of Group C combined with standard-of-care chemotherapy. • Evaluate the pharmacokinetics (PK) of CHS-114 combined with toripalimab, and the PK of Group C combined with standard-of-care chemotherapy. • Evaluate the immunogenicity of CHS-114 combined with toripalimab. Exploratory Objectives • Further evaluate the survival benefit of CHS-114 combined with toripalimab, and the survival benefit of Group C combined with standard-of-care chemotherapy. • Evaluate the pharmacokinetics (PK) of toripalimab combined with CHS-114, and the PK of Group C combined with standard-of-care chemotherapy. • Evaluate the immunogenicity of toripalimab combined with CHS-114, and the PK of Group C combined with standard-of-care chemotherapy. Immunogenicity of CHS-114 combined with standard-of-care chemotherapy • Assess the immunogenicity of CHS-114 combined with toripalimab, and the immunogenicity of CHS-114 combined with standard-of-care chemotherapy • Assess tumor immunobiomarkers and explore the potential relationship between CCR8+ Tregs and immune properties in the tumor microenvironment and clinical outcomes of CHS-114 and toripalimab treatment • Identify molecular (genomic, metabolic, and/or proteosome) and cellular biomarkers that may indicate clinical response/resistance, safety, pharmacodynamic activity, and/or mechanism of action of CHS-114 combined with toripalimab

Test Drug

靜脈點滴注射劑
靜脈點滴注射劑

Active Ingredient

CHS-114
Toripalimab

Dosage Form

242
242

Dosage

100 mg/2 mL
240mg/6mL

Endpoints

• AEs identified by type, frequency, severity (CRS according to ASTCT classification, all other AEs according to NCI-CTCAE version 5.0 classification), time, severity, and relationship to the investigational therapy.

• Abnormal laboratory test results identified by type, frequency, severity (according to NCI-CTCAE version 5.0 classification), and time characteristics.

Inclution 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 (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 approved standard therapies with a proven clinical benefit available in the participant's country. These therapies include 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, trifluridine/tipiracil 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.

Exclusion Criteria

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.

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    154 participants

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