Clinical trial · Interventional
Study of SC-003 Alone and in Combination With ABBV-181 in Subjects With Platinum-Resistant/Refractory Ovarian Cancer
A Phase 1a/1b Dose Escalation and Expansion Study of SC-003 as a Single-Agent and in Combination With ABBV-181 in Subjects With Platinum-Resistant/ Refractory Ovarian Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Strategic Considerations
Summary
Brief summary (as posted)
This is a Phase 1a/1b study of SC-003 as a single agent and in combination with ABBV-181 in patients with platinum-resistant/refractory ovarian cancer. SC-003 is an antibody-drug conjugate (ADC) comprised of a monoclonal antibody linked to a potent chemotherapy. ABBV-181 is a humanized, recombinant, mAb that binds to cell surface expressed programmed cell death 1 (PD-1).
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SC-003 | Drug | — | UNRESOLVED |
| SC-003 in combination with ABBV-181 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SC-003
- description
- Phase 1a (Escalation) - IV infusion Phase 1b (Expansion) - IV infusion
- interventionNames
- Drug: SC-003
- type
- EXPERIMENTAL
- label
- SC-003 in combination with ABBV-181
- description
- Phase 1a (Escalation) - IV infusion of SC-003 followed by IV infusion of ABBV-181 Phase 1b (Expansion) - IV Infusion of SC-003 followed by IV infusion of ABBV-181
- interventionNames
- Drug: SC-003 in combination with ABBV-181
Primary outcomes (1)
- measure
- Adverse Events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed ovarian epithelial cancer * Evidence of progressive disease (PD) on or within 6 months of a platinum (cisplatin or carboplatin) regimen: at least 1 prior regimen must have contained a platinum-taxane combination * Measurable disease as defined by RECIST 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Fresh or archived tumor tissue sample available for target expression analysis. \[Phase 1b only: Subjects' tumor tissue must test positive for target expression.\] * Adequate hematologic and organ function as confirmed by laboratory values * At least 3 weeks between last systemic chemotherapy and planned start of study treatment (4 weeks for prior investigational drugs, immunotherapy, radiotherapy, or biologics) for ovarian cancer * At least 3 weeks between major surgery and planned start of study treatment; major incisions must have healed Exclusion Criteria: * History of prior malignancy, with the exception of the following: malignancy treated with curative intent and with no evidence of active disease present for more than 3 years prior to screening and felt to be at low risk for recurrence by treating physician; or adequately treated lentigo maligna melanoma without current evidence of disease or adequately controlled non-melanomatous skin cancer; or adequately treated cervical carcinoma in situ without current evidence of disease. * Uncontrolled infection requiring systemic antibiotics/antivirals/antifungals * Evidence of complete or partial bowel obstruction * Patients requiring IV hydration or parenteral nutrition * Positive pregnancy test in females of child-bearing potential or pregnant or currently breastfeeding * Known hypersensitivity to any component of study drug including potential subjects with a history of major immunologic reaction to any IgG-containing agent * Inability to tolerate premedication with dexamethasone * Uncontrolled cardiac disease, or myocardial infarction within the last 12 months, or left ventricular ejection fraction (LVEF) \< 50%, or QTcF interval \> 470 msec * Class II, III or IV heart failure as defined by the NYHA functional class system * Positive serology for hepatitis B or C, or known human immunodeficiency virus infection (HIV) * Previous treatment with a pyrrolobenzodiazepine (PBD)-based drug Additional exclusion criteria for the SC-003 and ABBV-181 combination treatment regimen: * History of inflammatory bowel disease * Active autoimmune disease, with exceptions of psoriasis not requiring systemic treatment, vitiligo, type 1 diabetes mellitus and hypothyroidism * History of primary immunodeficiency, allogeneic bone marrow transplantation, solid organ transplantation, or previous clinical diagnosis of tuberculosis * History of immune-mediated pneumonitis * Current or prior use of immunosuppressive medication within 14 days prior to the first dose of study treatment
References
Publications (1)
- DERIVEDHamilton E, O'Malley DM, O'Cearbhaill R, Cristea M, Fleming GF, Tariq B, Fong A, French D, Rossi M, Brickman D, Moore K. Tamrintamab pamozirine (SC-003) in patients with platinum-resistant/refractory ovarian cancer: Findings of a phase 1 study. Gynecol Oncol. 2020 Sep;158(3):640-645. doi: 10.1016/j.ygyno.2020.05.038. Epub 2020 Jun 6. PMID 32513564