Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
Eligibility 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.
- * 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.
- * 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.
- * Received ≥ 2 prior systemic anticancer therapies for advanced or metastatic disease.
Ages Eligible for Study
18 Years to
Sexes Eligible for Study
ALL
Accepts Healthy Volunteers
No