NCT05456685

Inclusion Criteria:

1. Must be ≥ 18 years of age.

2. Must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1.

3. Must have a confirmed diagnosis of high-grade serous epithelial ovarian, primary
peritoneal, or fallopian tube cancer.

4. Must have relapsed after 1 prior line of platinum-based chemotherapy.

5. Must have platinum-sensitive disease defined as radiographic progression greater
than 6 months from last dose of platinum-based chemotherapy.

Note: Progression should be calculated from the date of the last administered dose
of platinum therapy to the date of the radiographic imaging showing progression.

6. If available locally and is the standard of care, breast cancer susceptibility gene
(BRCA) testing on the tumor or prior germline testing is required for eligibility,
and will need to be done prior to study entry. Somatic and germline BRCA-positive
participants must have received prior treatment with a poly adenosine
phosphate-ribose polymerase inhibitor (PARPi) unless documented as clinically
contraindicated.

7. Must have at least 1 lesion that meets the definition of measurable disease by
RECIST v1.1 (radiologically measured by the investigator).

8. Must 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 FRα positivity; FRα-expressing tumors
will be defined and classified by the Ventana FOLR1 Assay into low, medium, and high
expressions defined as 25%-49%, 50%-74%, and ≥ 75% of tumor cells with PS2+ staining
intensity, respectively. Must have confirmation of FRα positivity of ≥ 25% of tumor
staining at ≥ 2+ intensity for entry into the study.

9. Must have stabilized or recovered (Grade 1 or baseline) from all prior
therapy-related toxicities (except alopecia) and have discontinued any maintenance
therapy at least 4 weeks before the first dose of carboplatin plus MIRV.

10. Must have completed any major surgery at least 4 weeks before the first dose of
carboplatin plus MIRV and have recovered or stabilized from the side effects of
prior surgery before the first dose of carboplatin plus MIRV.

11. Must have adequate hematologic, liver, and kidney functions defined as:

1. Absolute neutrophil count ≥ 1.5 × 10^9/ liter(L) (1500/ microliter [μL])
without granulocyte colony-stimulating factor or long-acting white blood cell
growth factors in the 10 days prior to the Cycle 1 Day 1 (C1D1) dose

2. Platelet count ≥ 100 × 109/L (100,000/μL) without platelet transfusion in the
10 days prior to the C1D1 dose

3. Hemoglobin ≥ 9.0 grams/deciliter (g/dL) without packed red blood cell
transfusion in the 14 days prior to the C1D1 dose

4. Serum creatinine ≤ 1.5 × upper limit of normal (ULN)

5. Aspartate aminotransferase and alanine aminotransferase ≤ 3.0 × ULN

6. Serum bilirubin ≤ 1.5 × ULN (participants with documented diagnosis of Gilbert
syndrome are eligible if total bilirubin < 3.0 × ULN)

7. Serum albumin ≥ 2 g/dL

12. Must be willing and able to sign the informed consent form (ICF) and to adhere to
the protocol requirements.

13. Females of childbearing potential (FCBP) must agree to use highly effective
contraceptive method(s) while on study medication and for at least 3 months after
the last dose of MIRV and 6 months after the last dose of carboplatin.

14. FCBP must have a negative pregnancy test within the 4 days prior to the C1D1 dose.

Exclusion Criteria:

1. Participants with endometrioid, clear cell, mucinous, or sarcomatous histology,
mixed tumors containing any of the above types, or low-grade/borderline ovarian
tumor

2. More than one line of prior chemotherapy. Lines of prior anticancer therapy are
counted with the following considerations:

1. Neoadjuvant ± adjuvant therapies are considered 1 line of therapy if the
neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise,
they are counted as 2 prior regimens.

2. Maintenance therapy (eg, bevacizumab, PARPi) will be considered part of the
preceding line of therapy (ie, not counted independently).

3. Participants with prior wide-field radiotherapy affecting at least 20% of the bone
marrow

4. Participants with > Grade 1 peripheral neuropathy per Common Terminology Criteria
for Adverse Events (CTCAE)

5. Participants 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, or monocular vision

6. Participants with serious concurrent illness or clinically relevant active
infection, including, but not limited to the following:

1. Active hepatitis B virus (HBV) or hepatitis C virus (HCV)or C infection
(whether or not on active antiviral therapy)

2. HIV infection if inclusion clarifying eligibility for HIV positive participants
is not met

3. Active cytomegalovirus infection

4. Any other concurrent infectious disease requiring IV antibiotics within 2 weeks
prior to the first dose of carboplatin plus MIRV Note: Testing at screening is
not required for the above infections unless clinically indicated.

7. Participants with a history of multiple sclerosis or other demyelinating disease
and/or Lambert-Eaton syndrome (paraneoplastic syndrome)

8. Participants with clinically significant cardiac disease including, but not limited
to, any of the following:

1. Myocardial infarction ≤ 6 months prior to first dose

2. Unstable angina pectoris

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

4. Uncontrolled ≥ Grade 3 hypertension (per CTCAE)

5. Uncontrolled cardiac arrhythmias

9. Participants with a history of hemorrhagic or ischemic stroke within 6 months prior
to enrollment

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

11. Participants with a previous clinical diagnosis of noninfectious interstitial lung
disease, including noninfectious pneumonitis (exception: Grade 1 noninfectious
pneumonitis diagnosed on or within 6 weeks after treatment with an immunotherapeutic
agent used in the treatment of their malignancy that has resolved per investigator
or resolution of the radiologic findings)

12. Participants requiring use of folate-containing supplements (eg, folate deficiency)

13. Participants with prior hypersensitivity to monoclonal antibodies (mAb)

14. Females who are pregnant or breastfeeding

15. Participants who received prior treatment with MIRV or other FRα-targeting agents

16. Participants with untreated or symptomatic central nervous system metastases

17. Participants with a history of other malignancy within 3 years before enrollment
Note: Participants 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.

18. Prior known hypersensitivity reactions or known contraindications to study drugs or
any of their excipients