Clinical Trials

Inclusion Criteria:

- Patients must have biopsy-confirmed high grade serous epithelial ovarian cancer.

- Patients must present with stage III or IV disease and be appropriate to receive
neoadjuvant chemotherapy

- Patients must be willing to provide an archival tumor tissue block or slides, or
undergo procedure to obtain a new biopsy using a low-risk, medically routine procedure
for immunohistochemistry (IHC) confirmation of FR? positivity

- Patients must have a performance status of 0 or 1.

- Patient's tumor must be positive for FR? expression as defined by a score of PS2+
intensity in >75% of cells

- Patients must have adequate hematologic, liver and kidney functions defined as:

- Absolute neutrophil count (ANC) ≥ 1.5 x 109/L (1,500/?L)

- Platelet count ≥ 100 x 109/L (100,000/?L) without platelet transfusion in the prior 10
days

- Hemoglobin ≥ 9.0 g/dL

- Serum creatinine ≤ 1.5 x upper limit of normal (ULN)

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3.0 x ULN

- Serum bilirubin ≤ 1.5 x ULN (patients with documented diagnosis of Gilbert syndrome
are eligible if total bilirubin < 3.0 x ULN)

- Serum albumin ≥ 2 g/dL

- Patients must be willing and able to sign the informed consent form (ICF) and to
adhere to the protocol requirements

- Women of childbearing potential (WCBP) must agree to use highly effective
contraceptive method(s) (as defined in Section 5.8.6 while on MIRV and for at least 4
months after the last dose

- WCBP must have a negative pregnancy test within the 4 days prior to the first dose of
MIRV

Exclusion Criteria:

- Patients who have previously been treated with a systemic anti-cancer therapy

- Patients with low-grade serous, endometrioid, clear cell, or mucinous histology

- Patients with active or chronic corneal disorders, history of corneal transplantation,
or active ocular conditions requiring ongoing treatment/monitoring, such as
uncontrolled glaucoma, wet age-related macular degeneration requiring intravitreal
injections, active diabetic retinopathy with macular edema, macular degeneration,
presence of papilledema, and /or monocular vision

- Patients with serious concurrent illness or clinically relevant active infection,
including, but not limited to the following:

- History of hepatitis B or C infection (whether or not on active antiviral therapy)

- History of human immunodeficiency virus (HIV) infection

- Any other concurrent infectious disease requiring IV antibiotics within 2 weeks prior
to the first dose of MIRV

- Patients with a history of multiple sclerosis (MS) or other demyelinating disease
and/or Lambert-Eaton syndrome (paraneoplastic syndrome)

- Patients with clinically significant cardiac disease including, but not limited to,
any of the following:

- Myocardial infarction ≤ 6 months prior to first dose

- Unstable angina pectoris

- Uncontrolled congestive heart failure (New York Heart Association > class II)

- Uncontrolled ≥ Grade 3 hypertension (per CTCAE)

- Uncontrolled cardiac arrhythmias

- Patients with a history of hemorrhagic or ischemic stroke within 6 months prior to
enrollment

- Patients with a history of cirrhotic liver disease (Child-Pugh Class B or C)

- Patients with a previous clinical diagnosis of noninfectious interstitial lung disease
(ILD), including noninfectious pneumonitis

- Patients requiring use of folate-containing supplements (eg, folate deficiency)

- Patients with prior hypersensitivity to monoclonal antibodies (mAb)

- Women who are pregnant or breastfeeding

- Patients who received prior treatment with MIRV or other FR?-targeting agents

- Patients with untreated or symptomatic central nervous system (CNS) metastases

- Patients with a history of other malignancy within 3 years prior to enrollment Note:
patients with tumors with a negligible risk for metastasis or death (eg, adequately
controlled basal-cell carcinoma or squamous-cell carcinoma of the skin, or carcinoma
in situ of the cervix or breast) are eligible

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

Eligibility last updated 3/12/2024. Questions regarding updates should be directed to the study team contact.