Ensayos clínicos

Key Inclusion Criteria:

- Must have at least 1 measurable lesion per Response Evaluation Criteria in Solid
Tumors (RECIST) guidance

- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1

- Monotherapy-specific criteria for dose escalation cohorts:

- Participants may have pathologically confirmed NSCLC, gastric/GEJ, esophageal,
HNSCC, bladder, RCC, TNBC, cervical, and ovarian cancers for which standard
therapy has proven ineffective, intolerable, or considered inappropriate

- Disease-specific criteria for dose-expansion Cohort 1 (NSCLC):

- Histologically confirmed, documented diagnosis of locally advanced unresectable
or metastatic non-squamous NSCLC

- Treatment-naive in the unresectable locally advanced or metastatic setting

- Cannot have progressed within 6 months of prior platinum-based chemotherapy

- Mixed small-cell lung cancer histology is not permitted

- Disease-specific criteria for dose expansion Cohort 2 (Gastric/GEJ):

- Histologically confirmed, documented diagnosis of human epidermal growth factor 2
(HER2)-negative locally advanced unresectable or metastatic gastric or GEJ
adenocarcinoma

- No prior systemic treatment for locally advanced unresectable or metastatic
disease

- Cannot have progressed within 6 months of prior platinum-based chemotherapy

Key Exclusion Criteria:

- Use of any live vaccines against infectious diseases (eg, influenza, varicella) within
4 weeks (28 days) of initiation of study

- Underlying medical conditions or AEs that, in the investigator's or sponsor's opinion,
will make the administration of the study drugs hazardous

- Any active or documented history of autoimmune disease including but not limited to
inflammatory bowel disease, celiac disease, Wegner syndrome, Hashimoto syndrome,
systemic lupus erythematosus, scleroderma, sarcoidosis, or autoimmune hepatitis,
within 3 years of the first dose of study treatment

- History of trauma or major surgery within 28 days prior to the first dose of study
drug

- Treatment with systemic immunosuppressive medication within 2 weeks prior to
initiation of study treatment, or anticipation of need for systemic immunosuppressant
medication during study treatment with certain protocol specified exceptions

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 12/5/23. Questions regarding updates should be directed to the study team contact.