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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
Phase
Phase 1
Sponsor
Coherus Oncology, Inc.
Enrollment
154
Timeline
Apr 2025 → May 2027
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
Inclusion Criteria
- 1At least 1 measurable lesion based on RECIST v1.1 as determined by the Investigator.
- 2Resolved 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.
- 3Histologically 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).
- 4Progressed 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).
- 5Consent to provide tumor tissue samples (baseline and on-treatment) is required for enrollment.
- 6Histologically or cytologically documented unresectable, locally advanced or metastatic ESCC.
- 7Progressed 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.
- 8Consent to provide results from prior PD-L1 IHC assay score by FDA-approved or equivalent PD-L1 IHC diagnostic tests.
- 9Consent to provide archival tumor tissue sample (baseline) is required for enrolment.
- 10Histologically or cytologically documented unresectable, locally advanced or metastatic ESCC.
- 11Consent to provide baseline tumor tissue is required.
- 12Consent to provide results from prior PD-L1 IHC assay score by FDA-approved or equivalent PD-L1 IHC diagnostic tests.
- 13Calculated creatinine clearance ≥60 mL/min.
- 14Histologically 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.
- 15Participants who have no approved standard therapies with a proven clinical benefit available in the participant's country. These therapies include 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, trifluridine/tipiracil or regorafenib, and a BRAF inhibitor (ie, encorafenib) in BRAF V600E mutant).
- 16Participants 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.
- 17Consent to provide baseline tumor tissue sample is required for enrolment.
Exclusion Criteria
- 1History of prior malignancy other than the cancer under study that is progressing or has required active treatment within the past 3 years.
- 2Symptomatic or untreated central nervous system metastases, including leptomeningeal metastases, requiring concurrent treatment, including but not limited to surgery, radiation, and/or corticosteroids.
- 3Major 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.
- 4Prior exposure to anti-C-C motif chemokine receptor 8 (CCR8) antibody.
- 5History of Grade 4 allergic or anaphylactic reaction to any monoclonal antibody (mAb) therapy or any excipient in the study treatment.
- 6Active 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.
- 7Any condition that, in the opinion of the Investigator or Sponsor, would interfere with the interpretation of study results.
- 8Received ≥ 2 prior systemic anticancer therapies for advanced or metastatic disease.
- 9Participants 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).
- 10Received ≥ 2 prior systemic anticancer therapies for advanced or metastatic disease.
- 11Participants 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).
- 12Received ≥ 1 prior systemic anticancer therapies for advanced or metastatic disease.
- 13Participants who progressed during or within 6 months following the last dose of neoadjuvant, or perioperative therapy with curative intent.
- 14Participants 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).
- 15Known dihydropyrimidine dehydrogenase deficiency or thymidine synthase gene polymorphism predisposing the participant to 5-FU toxicity.
- 16Known allergies to 5-FU or cisplatin.
Locations
21 sites participating in this study
Winship Cancer Center - Emory University
Atlanta, Georgia 30322
Oluwadunni Emiloju, MD
The University of Arizona Cancer Center
Tucson, Arizona 85724
Aaron Scott, MD
City of Hope
Duarte, California 91010
Dani Castillo, MD
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →