Clinical trial · Interventional
A Study of SGN-CD228A in Advanced Solid Tumors
A Phase 1 Study of SGN-CD228A in Select Advanced Solid Tumors
NCT04042480CI-TRIAL-00064916terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study closed due to portfolio prioritization
Summary
Brief summary (as posted)
This trial will study SGN-CD228A to find out whether it is an effective treatment for different kinds of cancer. It will also look at what side effects (unwanted effects) may occur. The study will have two parts. Part 1 of the study will find out how much SGN-CD228A should be given for treatment and how often. Part 2 of the study will use the dose found in Part 1 and look at how safe and effective the treatment is.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Cutaneous Melanoma | Cutaneous Melanoma | ONTOLOGY_EXACT | 0.98 |
| HER2 Negative Breast Neoplasms | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Pancreatic Ductal Adenocarcinoma | Pancreatic Ductal Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pleural Mesothelioma | Pleural Mesothelial Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SGN-CD228A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SGN-CD228A
- description
- SGN-CD228A monotherapy
- interventionNames
- Drug: SGN-CD228A
Primary outcomes (3)
- measure
- Number of participants with adverse events
- timeFrame
- Up to approximately 3.5 years
- description
- Any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment.
- measure
- Number of participants with laboratory abnormalities
- timeFrame
- Up to approximately 3.5 years
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria
* Metastatic or unresectable solid malignancy that is histologically or cytologically confirmed to be one of the tumor types listed below. Participants must have relapsed, refractory, or progressive disease (PD) and should have no appropriate standard therapy available. Disease-specific escalation/expansion includes the following tumor types.
* Metastatic cutaneous melanoma(MCM):
* Metastatic or advanced cutaneous melanoma, excludes acral or mucosal varieties.
* Participants must have received at least 1 PD-1-targeted therapy unless contraindicated.
* Participants with targetable mutations should have received at least 1 therapy targeting that mutation unless contraindicated.
* Malignant pleural mesothelioma (MPM):
* Participants must have received cisplatin and pemetrexed unless contraindicated.
* Advanced HER2-negative breast cancer:
* Participants must have received 1 or more prior lines of therapy for locally advanced or metastatic disease. Prior therapies must include taxane.
* Hormone-receptor-positive subjects should have received CDK4/6 inhibitor therapy and have received at least 1 prior hormonally-directed therapy, unless contraindicated.
* Advanced non-small cell lung cancer (NSCLC):
* Participants must have locally advanced or metastatic EGFR wild-type NSCLC.
* Participants must have received platinum-based therapy and at least 1 PD-1- or PD-L1-targeted therapy as a single agent or as part of a combination unless contraindicated.
* Advanced colorectal cancer:
* Participants must have received 2 or more prior lines of therapy for locally advanced or metastatic disease, including targeted therapies as appropriate.
* Advanced pancreatic ductal adenocarcinoma (PDAC):
* Participants must have unresectable or advanced PDAC.
* Participants must have received 1 or more prior line of therapy for locally advanced or metastatic disease unless contraindicated.
* Participants should be able to provide adequate tumor tissue for biomarker analysis
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
* Measurable disease per Response Evaluation Criteria for Solid Tumors version 1.1 (RECIST v1.1)
Exclusion Criteria
* History of another malignancy within 3 years before the first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death.
* Pre-existing neuropathy Grade 2 or greater
* Retinal or macular disease requiring treatment or ongoing active monitoring
* Prior receipt of SGN-CD228A or MMAE-containing agentsReferences
Publications (1)
- DERIVEDMazahreh R, Mason ML, Gosink JJ, Olson DJ, Thurman R, Hale C, Westendorf L, Pires TA, Leiske CI, Carlson M, Nguyen LT, Cochran JH, Okeley NM, Yumul R, Jin S, Stone IJ, Sahetya D, Nesterova A, Allred S, Hensley KM, Hu R, Lawrence R, Lewis TS, Sandall S. SGN-CD228A Is an Investigational CD228-Directed Antibody-Drug Conjugate with Potent Antitumor Activity across a Wide Spectrum of Preclinical Solid Tumor Models. Mol Cancer Ther. 2023 Apr 3;22(4):421-434. doi: 10.1158/1535-7163.MCT-22-0401. PMID 36800443