A Study of Lorigerlimab in Participants With Advanced Solid Tumors

Inclusion criteria

• Histologically confirmed high-grade serous epithelial ovarian cancer, including primary peritoneal, or fallopian tube cancer, resistant to platinum based chemotherapy. OR
• Histologically confirmed clear cell carcinoma of the ovary (including primary peritoneal and fallopian tube), endometrium, vagina, vulva, or cervix.
• Persistent or recurrent disease with documented disease progression.
• Participants with PROC must have received at least 1 but not more than 3 prior lines of therapy for PROC.
• Participants with CCGC must have received at least 1 prior line of therapy for CCGC.
• Participants with a known breast cancer (BRCA) mutation (germline or somatic) must have received a Poly ADP-ribose polymerase (PARP) inhibitor, if locally approved and available, and experienced disease progression or intolerance on the PARP inhibitor.
• Participants must have at least one lesion that meets the definition of measurable disease by RECIST v1.1.
• Participants must have an available archival or formalin-fixed paraffin-embedded tumor tissue, or be willing to undergo a biopsy procedure to obtain a fresh tumor sample.
• Participants have acceptable physical condition and laboratory values.
• Participants of childbearing potential must agree to use highly effective methods of birth control.
• Participants must not be pregnant, planning to be pregnant, or breastfeeding.

Exclusion criteria

• Any underlying medical or psychiatric condition impairing participant's ability to receive, tolerate, or comply with the planned treatment or study procedures.
• Primary platinum-refractory disease, defined as disease that did not respond to (CR or PR) or has progressed within 3 months of the last dose of first-line platinum- containing chemotherapy.
• Prior treatment with a checkpoint inhibitor (e.g., anti-PD-1/PD-L1, anti-PD-L2, anti-CTLA-4). Prior use of immune checkpoint inhibitors (e.g., anti-PD-1, anti-PD-L1, anti-CTLA-4) is allowed for clear cell endometrial and clear cell cervical cancer.
• Active brain metastases or leptomeningeal metastases.
• Prior stem cell, tissue, or solid organ transplant.
• Paracentesis (removal of fluid from the abdomen) within 4 weeks prior to initiation of study treatment.
• Another hematologic or solid tumor ≥ stage 1 malignancy that completed surgery, last dose of radiotherapy, or last dose of systemic anti-cancer therapy ≤ 3 years from first dose of study treatment. Participants with another tumor that has a negligible risk for metastasis or death such as, adequately controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma in situ of the cervix or breast are eligible.