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Trial Title:
A Study of CHS-114 in Combination With Toripalimab and/or Other Treatments in Participants With Advanced Solid Tumors
NCT ID:
NCT06657144
Condition:
Metastatic Solid Tumor
Advanced Solid Tumor
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Solid Tumors
Advanced Solid Tumors
Metastatic Solid Tumor
Cancer
Oncology
Tumor
CCR8
PD-1
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
CHS-114
Description:
Sterile solution for infusion
Arm group label:
Arm A1: CHS-114 Dose A + Toripalimab
Arm group label:
Arm A1: CHS-114 Dose B + Toripalimab
Intervention type:
Drug
Intervention name:
Toripalimab
Description:
Sterile solution for infusion
Arm group label:
Arm A1: CHS-114 Dose A + Toripalimab
Arm group label:
Arm A1: CHS-114 Dose B + Toripalimab
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.
Criteria for 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-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 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 Specific Exclusion Criteria
- Received ≥ 2 prior systemic anticancer therapies for advanced or metastatic disease.
Note: Other protocol-specified inclusion/exclusion criteria may apply.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
March 2025
Completion date:
May 2027
Lead sponsor:
Agency:
Coherus Biosciences, Inc.
Agency class:
Industry
Source:
Coherus Biosciences, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06657144
