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Metastatic Solid TumorPhase 1NCT06657144

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

A Phase 1 study testing CHS-114, Toripalimab and 5 Fluorouracil in people with Metastatic Solid Tumor and Advanced Solid Tumor, run by Coherus Oncology, Inc. at 30 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Solid Tumor, Advanced Solid Tumor
What is being tested?
CHS-114, Toripalimab and 5 Fluorouracil
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
154 participants
Where
30 sitesin 2 countries
Study dates
1 Apr 2025to Jan 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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) 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.
Show all 21Show fewer
  • 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.

Who cannot join

  • 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.
Show all 20Show fewer
  • 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.

Trial locations and contacts

30 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Clinical Operations Team contact

+1-800-794-5434

clinicaltrials@coherus.com

30 sites in 2 countries

United States20 sites, 18 recruiting

  • Winship Cancer Center - Emory University

    Atlanta, Georgia, 30322

    Kathleen Coleman, 404-251-1278, kathleen.marie.coleman@emory.edu

    Oluwadunni Emiloju, MD

    Recruiting

  • University of Colorado - Aurora Cancer Center

    Aurora, Colorado, 80045

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

    Sunnie Kim, MD

    Recruiting

  • Texas Oncology - Central South

    Austin, Texas, 78731

    Marian Heaven, marian.heaven@usoncology.com

    Vivian Cline, MD

    Recruiting

  • Henry Ford Health System

    Detroit, Michigan, 48202

    CCTROGITeam@hfhs.org

    Gazala Khan, MD

    Recruiting

  • City of Hope

    Duarte, California, 91010

    Edwin Smura, 626-218-0115 ext. 80115, ESmura@coh.org

    Dani Castillo, MD

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Marcy Sullivan, Marcy.Sullivan@usoncology.com

    Mohamad A Salkeni, MD

    Recruiting

  • Prisma Health Cancer Institute

    Greenville, South Carolina, 29605

    Jill Roemmich, jill.roemmich@prismahealth.org

    Ki Chung, MD

    Recruiting

  • START New York

    Lake Success, New York, 11042

    Sadie Morium, 363-207-5166, sadia.morium@startresearch.com

    Geraldine O'Sullivan Coyne, MD

    Recruiting

  • Comprehensive Cancer Center of Nevada

    Las Vegas, Nevada, 89169

    AnaArlene Ramirez, 702-487-9428, anaarlene.ramirez@usoncology.com

    Kyaw Thein, MD

    Recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Karlie Williams, karlie.williams@scri.com

    Meredith S Pelster, MD

    Recruiting

  • Ochsner Health

    New Orleans, Louisiana, 70121

    Lauren Roddy, lauren.roddy@ochsner.org

    Jonathan Mizrahi, MD

    Recruiting

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

    New York, New York, 10065

    Amin Yaqubie, 646-888-4327, yaqubiea@mskcc.org

    Yelena Janjigian, MD

    Recruiting

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 11766

    Joseph Waters, Joseph.waters@mssm.edu

    Dan Feng, MD

    Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

    Withdrawn

  • University of Pittsburg Medical Center _UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

    Nicholas Kerin, 412-623-2466, kerinn@upmc.edu

    Anwaar Saeed, MD

    Recruiting

  • Huntsman Cancer Institute, University of Utah

    Salt Lake City, Utah, 84112

    Jamie White, 801-213-6106, jamie.white@hci.utah.edu

    Christopher Nevala-Plagemann, MD

    Recruiting

  • START San Antonio, LLC.

    San Antonio, Texas, 78229

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

    Amita Patnaik, MD

    Recruiting

  • Christus St Vincent Regional Medical Center

    Santa Fe, New Mexico, 87505

    Christopher Gallegos, christopher.gallegos@stvin.org

    Andrea Teague, MD

    Recruiting

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85724

    Withdrawn

  • START Mountain Region, LLC.

    West Valley City, Utah, 84119

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

    William McKean, MD

    Recruiting

Other trials in United States

Taiwan10 sites, 10 recruiting

  • Changhua Christian Hospital

    Chang-hua

    Ai-Ping Lai, +88647238595 ext. 3935, 96953@cch.org.tw

    Kuan-Ming Lai, MD

    Recruiting

  • E-Da Cancer Hospital

    Kaohsiung City, 824

    Wei-Ching Liu, +886-7-615-0022 ext. 6007, a0920365248@gmail.com

    Meng-Che Hsieh, MD

    Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

    Ya-Chieh Tsui, +886-918-957-721, candy10251025@hotmail.com

    Jaw-Yuan Wang, MD

    Recruiting

  • Taichung Veterans General Hospital

    Taichung, 40705

    Yi-Ru Lai, +886- 984-512-693, laiyiru0702@gmail.com

    Hsin-Chen Lin, MD

    Recruiting

  • China Medical University Hospital

    Taichung

    Ya-Hui Ding, 4-22052121 ext. 5051, hui6066@gmail.com

    Li-Yuan Bai, MD, PhD

    Recruiting

  • National Cheng Kung University Hospital

    Tainan, 704

    Ting-Yu Tseng, 866-6-235-3535 ext. 3041, hosp169230@gmail.com

    Chia-Jui Yen, MD

    Recruiting

  • Chi Mei Hospital

    Tainan, 736

    Olivia Chen, +886 6 6226191 ext. #77649, hospital77649@gmail.com

    Chien-Liang Lin, MD

    Recruiting

  • National Taiwan University Hospital

    Taipei, 10002

    Jia Ping Jiang, +886905925797, nancy9325@ntuh.gov.tw

    Chia-Chi Lin, MD

    Recruiting

  • Taipei Veterans General Hospital

    Taipei, 112

    Chiu-Mei Wang, +886 927751328, enjoy357208@gmail.com

    Ming-Huang Chen, MD

    Recruiting

  • Mackay Memorial Hospital

    Taipei

    Chia Jung Lee, +886-919301468, chialee113312@gmail.com

    Nai-Wen Su, MD

    Recruiting

Other trials in Taiwan

About this study

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)

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.

Being tested
CHS-114, Toripalimab, 5 Fluorouracil, Cisplatin
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)
Medical subject headings
Neoplasm Metastasis, Neoplasms, Stomach Neoplasms, Adenocarcinoma Of Esophagus, Esophageal Squamous Cell Carcinoma, Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06657144
Study groupRoleWhat they receive
Cohort A - Arm A1: CHS-114 Dose A + ToripalimabExperimentalParticipants will be treated with dose A of CHS-114 administered as an intravenous (IV) infusion in combination with toripalimab every 3 weeks (Q3W).
Receives: Drug: CHS-114; Drug: Toripalimab
Cohort A - Arm A2: CHS-114 Dose B + ToripalimabExperimentalParticipants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab Q3W.
Receives: Drug: CHS-114; Drug: Toripalimab
Cohort B - Arm B1: CHS-114 Dose A + ToripalimabExperimentalParticipants will be treated with dose A of CHS-114 administered as an IV infusion in combination with toripalimab Q3W.
Receives: Drug: CHS-114; Drug: Toripalimab
Cohort B - Arm B2: CHS-114 Dose B + ToripalimabExperimentalParticipants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab Q3W.
Receives: Drug: CHS-114; Drug: Toripalimab
Cohort C - Arm C: CHS-114 Dose B + Toripalimab + 5 fluorouracil (5 FU) + CisplatinExperimentalParticipants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab, 5 FU, and cisplatin Q3W.
Receives: Drug: CHS-114; Drug: Toripalimab; Drug: 5 Fluorouracil; Drug: Cisplatin
Experimental: Cohort D - Arm D1 (Liver Mets): CHS-114 + ToripalimabExperimentalParticipants will be treated with CHS-114 administered as an IV infusion in combination with toripalimab Q3W.
Receives: Drug: CHS-114; Drug: Toripalimab
Experimental: Cohort D - Arm D2 (Non-Liver Mets): CHS-114 + ToripalimabExperimentalParticipants will be treated with CHS-114 administered as an IV infusion in combination with toripalimab Q3W.
Receives: Drug: CHS-114; Drug: Toripalimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Treatment-emergent Adverse Events (TEAEs)

    Measured: From first dose of study drug until 90 days after the last dose of study drug (up to approximately 2.25 years)

Secondary outcomes (9)

  1. Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Investigator Assessment

    ORR is defined as percentage of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1.

    Measured: Up to approximately 2.25 years

  2. Duration of Response (DOR) Per RECIST v1.1 Based on Investigator Assessment

    DOR is defined as the time from first documentation of response (CR or PR) to first radiographic documentation of progressive disease or death due to any cause according to RECIST v1.1.

    Measured: Up to approximately 2.25 years

  3. Disease Control Rate (DCR) Per RECIST v1.1 Based on Investigator Assessment

    DCR is defined as the percentage of participants who achieve a confirmed CR or PR or stable disease (SD) lasting ≥ 12 weeks according to RECIST v1.1.

    Measured: Up to approximately 2.25 years

  4. Progression-free Survival (PFS) Per RECIST v1.1 Based on Investigator Assessment

    PFS is defined as the time of the first dose of study treatment to the time of the first documented unequivocal disease progression assessed per RECIST v1.1 or death due to any cause (whichever occurs first).

    Measured: Up to approximately 2.25 years

  5. Landmark PFS Rates

    Measured: Months 6, 9, and 12

  6. Maximum Observed Serum Concentration (Cmax) of CHS-114

    Measured: Up to approximately 2.25 years (pre-infusion and up to 336 hours post-infusion)

  7. Time to Reach Cmax (Tmax) of CHS-114

    Measured: Up to approximately 2.25 years (pre-infusion and up to 336 hours post-infusion)

  8. Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of CHS-114

    Measured: Up to approximately 2.25 years (pre-infusion and up to 336 hours post-infusion)

  9. Number of Participants With Anti-drug Antibodies (ADAs)

    Measured: Up to approximately 2.25 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2024
  2. Study start1 Apr 2025
  3. Primary completionJan 2028 (estimated)
  4. Study completionJan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
154 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06657144
Sponsor's protocol ID
CHS-114-102
Status last verified
Jul 2026
First submitted
23 Oct 2024
Last updated
15 Jul 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang X, Kapoor VN, Chin DJ, Klakamp SL, Baruffaldi F, Mohan JF, Haines R, Dulak A, Panduro M, Ren Y, Masia R, Hill JA, LaVallee TM, Rajasekaran N. CHS-114: An Afucosylated Anti-CCR8 Monoclonal Antibody that Selectively Depletes Intratumoral Treg Cells and Induces Antitumor Immune Responses. Mol Cancer Ther. 2026 May 4;25(5):685-700. doi: 10.1158/1535-7163.MCT-25-0367.

    PubMed 41423415

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CHS-114, Toripalimab and 5 Fluorouracil in people with Metastatic Solid Tumor and Advanced Solid Tumor, run by Coherus Oncology, Inc. at 30 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 30 sites in United States, Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Operations Team (+1-800-794-5434, clinicaltrials@coherus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the 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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06657144, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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