Summary

Eligibility

1. At least 1 measurable lesion based on RECIST v1.1 as determined by the Investigator.
2. 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:
3. 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).
4. 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).
5. 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:
6. Histologically or cytologically documented unresectable, locally advanced or metastatic ESCC.
7. 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.
8. Consent to provide results from prior PD-L1 IHC assay score by FDA-approved or equivalent PD-L1 IHC diagnostic tests.
9. Consent to provide archival tumor tissue sample (baseline) is required for enrolment. Cohort C (1L Esophageal Squamous Cell Carcinoma [ESCC]) - Specific Inclusion Criteria:
10. Histologically or cytologically documented unresectable, locally advanced or metastatic ESCC.
11. Consent to provide baseline tumor tissue is required.
12. Consent to provide results from prior PD-L1 IHC assay score by FDA-approved or equivalent PD-L1 IHC diagnostic tests.
13. Calculated creatinine clearance =60 mL/min. Cohort D (4L+ Colorectal Carcinoma [CRC]) - Specific Inclusion Criteria:
14. 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.
15. Participants who have no approved standard therapies with a proven clinical benefit available in the participant's country. These therapies include 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, trifluridine/tipiracil or regorafenib, and a BRAF inhibitor (ie, encorafenib) in BRAF V600E mutant).
16. 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.
17. Consent to provide baseline tumor tissue sample is required for enrolment. Key

Treatment Sites in Georgia