Ovarian, Peritoneal, Tubal; Frontline Including Maintenance

Key Eligibility
1.Patients with newly diagnosed, pathologically confirmed, FIGO Stage III or IV ovarian cancer of the following types:
∙ high grade serous,
∙ high grade endometrioid, and/or
∙ other epithelial ovarian cancer with BRCA1/2 deleterious alteration (germline or somatic).
Submission of pathology report is required.
2. Patients must have:
a) Documented variant (tumor or germline) in BRCA1 or BRCA2 that is predicted to be pathogenic or suspected pathogenic (deleterious alteration).
∙ Submission of testing report is required.
OR
b) BRCA 1/2 wildtype AND known HRD deficient tumor determined by any commercial or academic, CLIA-certified laboratory (e.g., Myriad MyChoice©)
∙ Submission of testing report is required.
Prior Treatment
• Patient must have undergone cytoreductive surgery (primary or interval).
• Patients must have completed first line platinum-based therapy prior to registration:
• Platinum based chemotherapy course must have consisted of a minimum of 4 treatment cycles and a maximum of 9, although it is strongly recommended that patients receive at least 6 cycles unless medically contraindicated.
• For those receiving less than 6 cycles of platinum-based therapy, the reason for this must be documented and could include hematologic toxicity or non-hematologic toxicities directly related to therapy.
• Intravenous, intraperitoneal, or neoadjuvant platinum-based chemotherapy is allowed; for weekly therapy, three weeks are considered one cycle.
• Patients must not have received an investigational agent during their first line course of chemotherapy.
• Patients must have, in the opinion of the investigator, no clinical evidence of disease progression following completion of this chemotherapy course (partial or complete response to platinum-based chemotherapy).
• Patients with treated brain metastases are eligible if follow up brain imaging after CNS directed therapy shows no evidence of progression and patients are neurologically stable off steroid therapy.
• Patients must be randomized at least 3 weeks and no more than 12 weeks after their last dose of chemotherapy (last dose is the day of the last infusion of platinum agent).
• No previous treatment with a PARP inhibitor, including olaparib, niraparib, and rucaparib.
• ECOG Performance Status of ≤ 2

Key Eligibility
Newly diagnosed AJCC Stage I, II, III testicular NSGCT
1. Observation Only Arm: AJCC Stage IA, IB, IS, Age less than 50 years old
Monthly tumor marker assessment x 1 year, q2 months for year 2, then q6 months for years 3 and 4.
CXR and abdomen/pelvis CT scan are required at 3 and 12 months.
2. Standard Risk 2 Arm: AJCC Stage II, II, and IGCCC Good Risk, age less than 25 years old.
Patients are randomized between receiving 3 cycles of BEP or BEC
Cycles are 21 days with visits on Day 1-5, 8 and 15. Next cycle begins on Day 22 or when eligibility
criteria are met .

Ovarian Germ Cell Tumors
1. Low risk stratum
No age limit
Newly diagnosed stage I, grade 2 or 3 immature teratoma
2. Standard risk 2 stratum
Age > 11 and < 25
Stage II-IV GCT containing yolk sac tumor and/or embryonal carcinoma and/or choriocarcinoma
3. Visit Summary:
Low risk stratum: Observation with tumor markers q 2 mos first year, q 3 months 2nd year, annually 3rd year, then as clinically
indicated. Imaging at 4 and 12 months in first year, then as clinically indicated.
Standard risk 1 stratum: 4 cycles of chemotherapy q 3 weeks
Standard risk 2 stratum: 3 cycles of chemotherapy q 4 weeks

Key Eligibility Criteria:

Inclusion Criteria:
1. Disease-specific Inclusion Criteria in Phase 1b Expansion Cohorts: Ovarian Cancer
a) Histologically or cytologically confirmed epithelial ovarian, primary peritoneal, or fallopian tube carcinoma. Carcinosarcomas are also eligible.
b) Participants who had received one line of platinum-based therapy must have received at least four cycles of their initial platinum-containing regimen, had a response (complete or partial), and then had disease progression between 3 and 6 months after their last dose. Participants who had previously received two or three lines of platinum-based therapy must have had disease progression while receiving the therapy or within 6 months after the last dose.
c) At least 1 but no more than 4 prior lines of systemic therapy.

2. Disease-specific Inclusion Criteria in Phase 1b Expansion Cohorts: Endometrial Cancer
a) Histologically confirmed endometrial adenocarcinoma regardless of mismatch repair deficiency status.
b)Relapsed or progressive disease after at least one prior line of systemic therapy.
c)Disease not amenable to curative surgery or radiation.
d)At least 1 but no more than 3 prior lines of systemic therapy in any setting. Prior endocrine therapy is not counted as a prior line of systemic therapy.

Disease-specific Inclusion Criteria in Phase 1b Expansion Cohorts: Cholangiocarcinoma
a) Histologically or cytologically confirmed advanced cholangiocarcinoma (intrahepatic, extrahepatic, or hilar). Advanced gallbladder adenocarcinomas are also eligible. Ampullary carcinomas are not eligible in Phase 1b.
b) Unresectable, locally advanced, or metastatic disease.
c) Disease progression during or after at least one prior line of systemic therapy for advanced disease.
d) At least 1 but no more than 3 prior lines of systemic therapy for advanced disease.

Exclusion Criteria:
1. Participant has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant’s participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating Investigator.
2. Participant has received previous treatment with another agent targeting CD24.
3. Disease-specific Exclusion Criteria in Phase 1b Expansion Cohorts: Ovarian Cancer
a) Non-epithelial ovarian tumors or ovarian tumors of low malignant potential
4. Disease-specific Exclusion Criteria in Phase 1b Expansion Cohorts: Endometrial Cancer
a) Carcinosarcoma histology
5. Disease-specific Exclusion Criteria in Phase 1b Expansion Cohorts: Cholangiocarcinoma
a) Ampullary carcinoma (unless specifically cholangiocarcinoma histology)
b) Gallbladder cancers other than adenocarcinomas.

For pre-screening, please contact: Message Basket: VICC RESEARCH PHASE 1