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New cancer cocktail enters human testing

NCT ID NCT06657144

Disease control Sponsor: Coherus Oncology, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 16, 2026 · Updated 3 times

Summary

This early-stage trial is testing an experimental drug called CHS-114 combined with the immunotherapy toripalimab, with or without standard chemotherapy, in 154 people with advanced or metastatic solid tumors. The main goal is to see if the combination is safe and to get an early look at whether it can shrink tumors. Researchers are also checking how long any response lasts.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CHS-114 (an experimental drug) combined with toripalimab (an immunotherapy) and possibly chemotherapy drugs (5-fluorouracil, cisplatin)
What this could lead to
If successful, this could point toward a new combination treatment option for people with advanced or metastatic solid tumors that have not responded to other therapies.
What could go wrong
This is an early Phase 1 trial with only 154 participants, focused mainly on safety. The combination may not shrink tumors or could cause significant side effects. Results may not apply to all cancer types.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 154 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Adenocarcinoma Of Esophagus colorectal adenocarcinoma colorectal neoplasm esophageal adenocarcinoma esophageal squamous cell carcinoma gastric adenocarcinoma gastric neoplasm gastroesophageal junction adenocarcinoma metastatic malignant neoplasm neoplasm Neoplasm Metastasis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Metastatic solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    28 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Changhua Christian Hospital

    RECRUITING

    Chang-hua, Taiwan

  • Chi Mei Hospital

    RECRUITING

    Tainan, 736, Taiwan

    Contact Email: •••••@•••••

  • China Medical University Hospital

    RECRUITING

    Taichung, Taiwan

  • Christus St Vincent Regional Medical Center

    RECRUITING

    Santa Fe, New Mexico, 87505, United States

  • City of Hope

    RECRUITING

    Duarte, California, 91010, United States

  • Comprehensive Cancer Center of Nevada

    RECRUITING

    Las Vegas, Nevada, 89169, United States

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

    RECRUITING

    New York, New York, 10065, United States

  • E-Da Cancer Hospital

    RECRUITING

    Kaohsiung City, 824, Taiwan

  • Henry Ford Health System

    RECRUITING

    Detroit, Michigan, 48202, United States

    Contact Email: •••••@•••••

  • Huntsman Cancer Institute, University of Utah

    RECRUITING

    Salt Lake City, Utah, 84112, United States

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 11766, United States

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    RECRUITING

    Kaohsiung City, Taiwan

  • Mackay Memorial Hospital

    RECRUITING

    Taipei, Taiwan

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, 704, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, 10002, Taiwan

  • Ochsner Health

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Prisma Health Cancer Institute

    RECRUITING

    Greenville, South Carolina, 29605, United States

  • SCRI Oncology Partners

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • START Mountain Region, LLC.

    RECRUITING

    West Valley City, Utah, 84119, United States

  • START New York

    RECRUITING

    Lake Success, New York, 11042, United States

  • START San Antonio, LLC.

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, 40705, Taiwan

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, 112, Taiwan

  • Texas Oncology - Central South

    RECRUITING

    Austin, Texas, 78731, United States

  • The University of Arizona Cancer Center

    WITHDRAWN

    Tucson, Arizona, 85724, United States

  • University of Colorado - Aurora Cancer Center

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Pittsburg Medical Center _UPMC Hillman Cancer Center

    RECRUITING

    Pittsburgh, Pennsylvania, 15232, United States

  • Virginia Cancer Specialists

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Virginia Oncology Associates

    WITHDRAWN

    Norfolk, Virginia, 23502, United States

  • Winship Cancer Center - Emory University

    RECRUITING

    Atlanta, Georgia, 30322, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.