An Open-label, Dose-escalation, Phase 1 Study to Investigate the Safety and Tolerability of WM-A1-3389, in Combination With Pembrolizumab in Patients With Advanced or Metastatic Solid Tumors and Non-Small Cell Lung Cancer
The purpose of the present study is to determine the safety, tolerability, and efficacy of WM-A1-3389 in combination with pembrolizumab in participants with advanced or metastatic solid tumors and non-small cell lung cancer (NSCLC).
• \[Stage 1: monotherapy\]
• Be ≥19 and \<75 years of age
• Participant with histologically and/or cytologically confirmed diagnosis of unresectable advanced or metastatic solid tumors that have been confirmed as progressed disease after standard of care or for which no further standard therapy is available due to intolerance or incompatibility
• IGSF1 positive expression
• Have measurable disease defined as at least one lesion based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Have life expectancy ≥ 12 weeks
• Have adequate organ functions defined as the following laboratory test criteria at screening (During the screening phase, one re-test will be permitted):
∙ Absolute neutrophil count (ANC) ≥ 1,500/mm3
‣ Platelet count ≥ 100,000/mm3
‣ Hemoglobin (Hb) ≥ 9 g/dL
‣ Total bilirubin ≤ 1.5 X Institutional Upper Limit of Normal (IULN) (Not applicable to patients with Gilbert syndrome)
‣ Serum creatinine ≤ 1.5 X IULN
‣ Aspartate aminotransferase (AST) and/or Alanine aminotransferase (ALT) ≤ 2.5 X IULN (AST and ALT ≤ 5 X IULN in patients with confirmed liver metastasis)
‣ Prothrombin time (PT) ≤ 1.5 X IULN \*IULN: Institutional Upper Limit of Normal
• Have provided archival tumor tissue sample obtained within 3 months prior to IP administration or newly obtained biopsy
• Have agreed to undergo up to 2 tumor tissue biopsies after IP administration
⁃ Participant (or legally acceptable representative if applicable) provides written informed consent for the trial
• \[Stage 2: Combination therapy\]
• Be ≥ 19 and \< 75 years of age
• Participant with histologically and/or cytologically confirmed diagnosis of unresectable advanced or metastatic NSCLC
∙ Have been confirmed as progressive disease after standard of care or for which no further standard therapy is available due to intolerance or incompatibility
‣ Have been confirmed as progressive disease during or after anti-cancer therapy including programmed cell death protein 1 (PD-1) inhibitors and programmed cell death-Ligand 1 (PD-L1) inhibitors
‣ IGSF1 positive expression
‣ PD-L1 low or negative expression (tumor proportion score \[TPS\] \< 50%)
• Have measurable disease defined as at least one lesion based on Response Evaluation Criteria In Solid Tumors (RECIST) v1.1
• Have ECOG performance status score of 0 or 1
• Have life expectancy ≥ 12 weeks
• Have adequate organ functions defined as the following laboratory test criteria at screening (During the screening period, one re-test will be permitted):
∙ Absolute neutrophil count (ANC) ≥ 1500/mm3
‣ Platelet count ≥ 100,000/mm3
‣ Hemoglobin (Hb) ≥ 9 g/dL
‣ Total bilirubin ≤ 1.5 X IULN (Not applicable to patients with Gilbert's syndrome)
‣ Serum creatinine ≤ 1.5 X IULN
‣ Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) ≤ 2.5 X IULN (AST and ALT ≤ 5 X IULN in patients with confirmed liver metastasis)
‣ Prothrombin time (PT) ≤ 1.5 X IULN \*IULN: Institutional Upper Limit of Normal
• Have provided archival tumor sample obtained within 3 months prior to IP administration or newly obtained biopsy prior to IP administration
• Have agreed to undergo up to 2 tumor tissue biopsies after IP administration
• Participant (or legally acceptable representative if applicable) provides written infromed consent for the trial