Recruiting

Phase 1

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

Sponsor:

Coherus Oncology, Inc.

Code:

NCT06657144

Conditions

Metastatic Solid Tumor

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CHS-114

Toripalimab

5 Fluorouracil

Cisplatin

Study Details

Brief summary:

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.

Conditions

Metastatic Solid Tumor

Advanced Solid Tumor

Study ID

NCT06657144

Start date

Apr 1, 2025

Status verified date

Jul, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

154 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort A - Arm A1: CHS-114 Dose A + Toripalimab

Participants will be treated with dose A of CHS-114 administered as an intravenous (IV) infusion in combination with toripalimab every 3 weeks (Q3W).

experimental: Cohort A - Arm A2: CHS-114 Dose B + Toripalimab

Participants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab Q3W.

experimental: Cohort B - Arm B1: CHS-114 Dose A + Toripalimab

Participants will be treated with dose A of CHS-114 administered as an IV infusion in combination with toripalimab Q3W.

experimental: Cohort B - Arm B2: CHS-114 Dose B + Toripalimab

Participants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab Q3W.

experimental: Cohort C - Arm C: CHS-114 Dose B + Toripalimab + 5 fluorouracil (5 FU) + Cisplatin

Participants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab, 5 FU, and cisplatin Q3W.

experimental: Experimental: Cohort D - Arm D1 (Liver Mets): CHS-114 + Toripalimab

Participants will be treated with CHS-114 administered as an IV infusion in combination with toripalimab Q3W.

experimental: Experimental: Cohort D - Arm D2 (Non-Liver Mets): CHS-114 + Toripalimab

Participants will be treated with CHS-114 administered as an IV infusion in combination with toripalimab Q3W.

Interventions

CHS-114

Solution for infusion

Toripalimab

Solution for infusion

5 Fluorouracil

Solution for infusion

Cisplatin

Solution for infusion

Primary outcome measure

Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: From first dose of study drug until 90 days after the last dose of study drug (up to approximately 2.25 years) ]

Central Contacts and Locations

Central contacts

Clinical Operations Team

+1-800-794-5434 clinicaltrials@coherus.com

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Edwin Smura

626-218-0115 ESmura@coh.org

Principal Investigator:

Dani Castillo, MD

University of Colorado - Aurora Cancer Center

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Emily Harper

303-724-9407 Emily.harper@cuanschutz.edu

Principal Investigator:

Sunnie Kim, MD

Winship Cancer Center - Emory University

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Kathleen Coleman

404-251-1278 kathleen.marie.coleman@emory.edu

Principal Investigator:

Oluwadunni Emiloju, MD

Ochsner Health

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Lauren Roddy

lauren.roddy@ochsner.org

Principal Investigator:

Jonathan Mizrahi, MD

Henry Ford Health System

Recruiting

Detroit, Michigan, United States, 48202

Contacts

CCTROGITeam@hfhs.org

Principal Investigator:

Gazala Khan, MD

Comprehensive Cancer Center of Nevada

Recruiting

Las Vegas, Nevada, United States, 89169

Contacts

AnaArlene Ramirez

702-487-9428 anaarlene.ramirez@usoncology.com

Principal Investigator:

Kyaw Thein, MD

Christus St Vincent Regional Medical Center

Recruiting

Santa Fe, New Mexico, United States, 87505

Contacts

Christopher Gallegos

christopher.gallegos@stvin.org

Principal Investigator:

Andrea Teague, MD

START New York

Recruiting

Lake Success, New York, United States, 11042

Contacts

Sadie Morium

363-207-5166 sadia.morium@startresearch.com

Principal Investigator:

Geraldine O'Sullivan Coyne, MD

David H. Koch Center for Cancer Care at Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Amin Yaqubie

646-888-4327 yaqubiea@mskcc.org

Principal Investigator:

Yelena Janjigian, MD

Icahn School of Medicine at Mount Sinai

Recruiting

New York, New York, United States, 11766

Contacts

Joseph Waters

Joseph.waters@mssm.edu

Principal Investigator:

Dan Feng, MD

University of Pittsburg Medical Center _UPMC Hillman Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Contacts

Nicholas Kerin

412-623-2466 kerinn@upmc.edu

Principal Investigator:

Anwaar Saeed, MD

Prisma Health Cancer Institute

Recruiting

Greenville, South Carolina, United States, 29605

Contacts

Jill Roemmich

jill.roemmich@prismahealth.org

Principal Investigator:

Ki Chung, MD

SCRI Oncology Partners

Recruiting

Nashville, Tennessee, United States, 37203

Contacts

Karlie Williams

karlie.williams@scri.com

Principal Investigator:

Meredith S Pelster, MD

Texas Oncology - Central South

Recruiting

Austin, Texas, United States, 78731

Contacts

Marian Heaven

marian.heaven@usoncology.com

Principal Investigator:

Vivian Cline, MD

START San Antonio, LLC.

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Isabel Jimenez

210-593-5265 Isabel.jimenez@startresearch.com

Principal Investigator:

Amita Patnaik, MD

Huntsman Cancer Institute, University of Utah

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Jamie White

801-213-6106 jamie.white@hci.utah.edu

Principal Investigator:

Christopher Nevala-Plagemann, MD

START Mountain Region, LLC.

Recruiting

West Valley City, Utah, United States, 84119

Contacts

Marie Asay

801-907-4770 Marie.asay@startresearch.com

Principal Investigator:

William McKean, MD

Virginia Cancer Specialists

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Marcy Sullivan

Marcy.Sullivan@usoncology.com

Principal Investigator:

Mohamad A Salkeni, MD

More Information

Sponsor

Coherus Oncology, Inc.

Last update posted

Jul 15, 2026

Last verified

Jul, 2026

Keywords

Solid Tumors
Advanced Solid Tumors
Metastatic Solid Tumor
Cancer
Oncology
Tumor
CCR8
PD-1
Gastric cancer
Gastro-esophageal-junction (GEJ) cancer
Esophageal Adenocarcinoma (EAC)
Esophageal Squamous Cell Carcinoma
Cisplatin
5 Fluorouracil (5-FU)
Colorectal Carcinoma (CRC)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Coherus Oncology, Inc. on 2026-07-15.