A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Participants With a Solid Tumor (SEASTAR)

SEASTAR: A Phase 1b/2, Open-label, Parallel Arm Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Oral Rucaparib in Combination With Other Anticancer Agents in Patients With a Solid Tumor

This is an open label, Phase 1b/2 study with multiple treatment arms evaluating the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of rucaparib in combination with a second anticancer therapy in participants with an advanced/metastatic solid malignancy (Phase 1b), followed by evaluation of the combination in one or more specific participant populations in an expansion phase (Phase 2 cohorts).

Inclusion Criteria Phase 1b (all arms):

• Solid tumor, advanced or metastatic, progressed on standard treatment participants in Arm B must have either triple negative breast cancer OR urothelial carcinoma OR ovarian cancer OR have a solid tumor with a deleterious mutation in BRCA1, BRCA2, PALB2, RAD51C or RAD51D
• Measurable disease per RECIST v1.1
• Adequate organ function
• Eastern Cooperative Oncology Group (ECOG) 0 or 1
• Tumor tissue for genomic analysis

Exclusion Criteria Phase 1b (all arms):

• Known history of myelodysplastic syndrome (MDS)
• Symptomatic and/or untreated central nervous system (CNS) metastases

Inclusion Criteria Phase 2 (all arms):

• Histologically or cytologically confirmed solid tumor, previously treated and measurable per RECIST v1.1, as follows:
• Arm A: ovarian cancer with gBRCAwt disease, either platinum-sensitive OR platinum-resistant
• Arm B: Metastatic triple negative breast cancer OR advanced/ metastatic urothelial carcinoma OR relapsed ovarian cancer
• At least 1 prior line of standard therapy for advanced disease
• Adequate organ function
• ECOG 0 or 1
• Tumor tissue for genomic analysis

Exclusion Criteria Phase 2 (all arms):

• Prior poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor treatment allowed for participants with ovarian cancer
• Known history of MDS
• Symptomatic and/or untreated CNS metastases