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

Launched by COHERUS BIOSCIENCES, INC. · Oct 23, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a new treatment called CHS-114, which is being studied in combination with another treatment called toripalimab, and possibly other standard therapies, for patients with advanced solid tumors that have spread to other parts of the body. The main goal is to find out if this combination is safe and if it can effectively help patients whose cancer has not responded to previous treatments.

To join the study, participants must be adults aged 65 or older and have at least one measurable tumor that can be evaluated. They should have a specific type of stomach cancer that has progressed after initial treatment. Additionally, patients must be able to provide tumor tissue samples for testing. However, those with certain health issues, like recent major surgery or active infections, may not qualify. If you or a loved one is looking for new treatment options for advanced cancer, this study could be an important opportunity to consider. Participants will receive close monitoring and care throughout the trial.

Gender

ALL

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.
• 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.