Metastatic Solid Tumor, Advanced Solid Tumor
Conditions
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)
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.
Interventions
DRUGCHS-114
Solution for infusion
DRUGToripalimab
Solution for infusion
DRUG5 Fluorouracil
Solution for infusion
DRUGCisplatin
Solution for infusion
Sponsors
Coherus Oncology, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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. 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From first dose of study drug until 90 days after the last dose of study drug (up to approximately 2.25 years) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Based on Investigator Assessment | Up to approximately 2.25 years | ORR is defined as percentage of participants with confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. |
| Duration of Response (DOR) Per RECIST v1.1 Based on Investigator Assessment | Up to approximately 2.25 years | 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. |
| Disease Control Rate (DCR) Per RECIST v1.1 Based on Investigator Assessment | Up to approximately 2.25 years | 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. |
| Progression-free Survival (PFS) Per RECIST v1.1 Based on Investigator Assessment | Up to approximately 2.25 years | 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). |
| Landmark PFS Rates | Months 6, 9, and 12 | — |
| Maximum Observed Serum Concentration (Cmax) of CHS-114 | Up to approximately 2.25 years (pre-infusion and up to 336 hours post-infusion) | — |
| Time to Reach Cmax (Tmax) of CHS-114 | Up to approximately 2.25 years (pre-infusion and up to 336 hours post-infusion) | — |
| Area Under the Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of CHS-114 | Up to approximately 2.25 years (pre-infusion and up to 336 hours post-infusion) | — |
| Number of Participants With Anti-drug Antibodies (ADAs) | Up to approximately 2.25 years | — |
Countries
Taiwan, United States
Contacts
CONTACTClinical Operations Team
Outcome results
None listed