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

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

Due to a change in development priorities, no further clinical development of the lucitanib plus rucaparib or lucitanib plus sacituzumab govitecan combinations is planned at this time.

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).

Participants will receive oral rucaparib twice daily (BID) and oral lucitanib once daily (QD) continuously in 28-day cycles.

Participants will receive oral rucaparib BID, administered continuously, in combination with intravenous (IV) sacituzumab govitecan administration on Day 1 and Day 8 of a 21-day cycle.

Participants will receive oral rucaparib QD, administered continuously, in combination with IV sacituzumab govitecan administration on Day 1 and Day 8 of a 21-day cycle.

Number of Participants With Objective Response, as Assessed by the Investigator Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v)1.1 (Phase 2)

From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years

From the date of first best response to disease progression or death, whichever occurs first, assessed up to 2 years

From the first dose of study drug to documented radiographic progression or death, whichever occurs first, assessed up to 2 years

Number of Participants With Objective Response, as Assessed by the Investigator Per RECIST v1.1 (Phase 1b)

From the first dose of study drug until the date of documented response to treatment, assessed up to 2 years

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