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A Study of CHS-114 (Tagmokitug) in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors
NCT06657144 · Coherus Oncology, Inc.
In plain English
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Official title
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)
About this study
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.
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 design
Enrollment target: 154 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-04-01
Estimated completion: 2028-01
Last updated: 2026-04-06
Interventions
Drug: CHS-114Drug: ToripalimabDrug: 5 FluorouracilDrug: Cisplatin
Primary outcomes
- • Number of Participants With Treatment-emergent Adverse Events (TEAEs) (From first dose of study drug until 90 days after the last dose of study drug (up to approximately 2.25 years))
Sponsor
Coherus Oncology, Inc. · industry
Contacts & investigators
ContactClinical Operations Team · contact · clinicaltrials@coherus.com · +1-800-794-5434
All locations (30)
The University of Arizona Cancer CenterWithdrawn
Tucson, Arizona, United States
City of HopeRecruiting
Duarte, California, United States
University of Colorado - Aurora Cancer CenterRecruiting
Aurora, Colorado, United States
Winship Cancer Center - Emory UniversityRecruiting
Atlanta, Georgia, United States
Ochsner HealthRecruiting
New Orleans, Louisiana, United States
Henry Ford Health SystemRecruiting
Detroit, Michigan, United States
Comprehensive Cancer Center of NevadaRecruiting
Las Vegas, Nevada, United States
Christus St Vincent Regional Medical CenterRecruiting
Santa Fe, New Mexico, United States
START New YorkRecruiting
Lake Success, New York, United States
David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer CenterRecruiting
New York, New York, United States
Icahn School of Medicine at Mount SinaiRecruiting
New York, New York, United States
University of Pittsburg Medical Center _UPMC Hillman Cancer CenterRecruiting
Pittsburgh, Pennsylvania, United States
Prisma Health Cancer InstituteRecruiting
Greenville, South Carolina, United States
SCRI Oncology PartnersRecruiting
Nashville, Tennessee, United States
Texas Oncology - Central SouthRecruiting
Austin, Texas, United States
START San Antonio, LLC.Recruiting
San Antonio, Texas, United States
Huntsman Cancer Institute, University of UtahRecruiting
Salt Lake City, Utah, United States
START Mountain Region, LLC.Recruiting
West Valley City, Utah, United States
Virginia Cancer SpecialistsRecruiting
Fairfax, Virginia, United States
Virginia Oncology AssociatesRecruiting
Norfolk, Virginia, United States
Changhua Christian HospitalRecruiting
Chang-hua, Taiwan
E-Da Cancer HospitalRecruiting
Kaohsiung City, Taiwan
Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
Kaohsiung City, Taiwan
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
China Medical University HospitalRecruiting
Taichung, Taiwan
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
Chi Mei HospitalRecruiting
Tainan, Taiwan
National Taiwan University HospitalRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
Mackay Memorial HospitalRecruiting
Taipei, Taiwan