A Study of Lorigerlimab in Participants With Advanced Solid Tumors

Launched by MACROGENICS · Dec 9, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called lorigerlimab for women with certain types of advanced cancers, specifically those that are resistant to platinum-based chemotherapy. The trial will include about 60 participants who have conditions like platinum-resistant ovarian cancer or clear cell gynecologic cancers. To be eligible, participants must have a confirmed diagnosis of these cancers, have experienced disease progression after at least one prior treatment, and must be in good physical health.

During the trial, participants will receive lorigerlimab through an IV every 21 days and will be closely monitored for side effects and how their cancer responds to the treatment. This monitoring includes regular check-ups and lab tests. The study is not yet recruiting participants, and those who join will have a follow-up visit after their treatment ends to ensure their safety. It’s important for potential participants to be aware that they should not be pregnant or breastfeeding and must agree to use effective birth control if they are capable of becoming pregnant.

Gender

FEMALE

Eligibility criteria

• 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 ovarian (including primary peritoneal and fallopian tube), endometrial, vaginal, vulval, or cervical cancer.
• • 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 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).
• • Active brain metastases or leptomeningeal metastases.
• • Prior stem cell, tissue, or solid organ transplant.
• • 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.