A Study of CHS-114 in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors
- Conditions
- Interventions
- Registration Number
- NCT06657144
- Lead Sponsor
- Coherus Biosciences, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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-Specific Inclusion Criteria
- Histologically or cytologically documented unresectable, locally advanced or metastatic gastric adenocarcinoma or adenocarcinoma of gastro-esophageal-junction (GEJ) 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.
Key
- 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 Specific Exclusion Criteria
- Received ≥ 2 prior systemic anticancer therapies for advanced or metastatic disease.
Note: Other protocol-specified inclusion/exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm A1: CHS-114 Dose B + Toripalimab Toripalimab Participants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab Q3W. Participants will remain on study treatment for approximately 2 years. Arm A1: CHS-114 Dose A + Toripalimab CHS-114 Participants will be treated with dose A of CHS-114 administered as an intravenous (IV) infusion in combination with toripalimab every 3 weeks (Q3W). Participants will remain on study treatment for approximately 2 years. Arm A1: CHS-114 Dose A + Toripalimab Toripalimab Participants will be treated with dose A of CHS-114 administered as an intravenous (IV) infusion in combination with toripalimab every 3 weeks (Q3W). Participants will remain on study treatment for approximately 2 years. Arm A1: CHS-114 Dose B + Toripalimab CHS-114 Participants will be treated with dose B of CHS-114 administered as an IV infusion in combination with toripalimab Q3W. Participants will remain on study treatment for approximately 2 years.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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