Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): 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.
Summary
Brief summary (as posted)
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).
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Triple-negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lucitanib | Drug | Lucitanib | ALIAS |
| Rucaparib | Drug | Rucaparib | ALIAS |
| Sacituzumab govitecan | Drug | Sacituzumab Govitecan | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Arm A: Rucaparib and Lucitanib
- description
- Participants will receive oral rucaparib twice daily (BID) and oral lucitanib once daily (QD) continuously in 28-day cycles.
- interventionNames
- Drug: Rucaparib
- Drug: Lucitanib
- type
- EXPERIMENTAL
- label
- Arm B: Rucaparib BID and Sacituzumab Govitecan
- description
- 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.
- interventionNames
- Drug: Rucaparib
- Drug: Sacituzumab govitecan
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available