Clinical trial · Interventional
A Study of SGN-STNV in Advanced Solid Tumors
A Phase 1 Study of SGN-STNV in Advanced Solid Tumors
NCT04665921CI-TRIAL-00085666terminatedPhase 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 look at a drug called SGN-STNV to find out whether it is safe for patients with solid tumors. It will study SGN-STNV to find out what its side effects are. A side effect is anything the drug does besides treating cancer. It will also study how well SGN-STNV works to treat solid tumors. The study will have two parts. Part A of the study will find out how much SGN-STNV should be given to patients. Part B will use the dose found in Part A to find out how safe SGN-STNV is and if it works to treat certain types of solid tumors.
Conditions
Conditions (12)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Appendiceal Adenocarcinoma | Appendix Adenocarcinoma | ALIAS | 0.90 |
| Carcinoma, Non-Small Cell Lung | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Endometrial Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Esophageal Neoplasms | Esophageal Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Exocrine Pancreatic Adenocarcinoma | — | UNRESOLVED | — |
| Gastroesophageal Junction Carcinoma | Gastroesophageal Junction Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SGN-STNV | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SGN-STNV
- description
- SGN-STNV monotherapy
- interventionNames
- Drug: SGN-STNV
Primary outcomes (3)
- measure
- Incidence of adverse events (AEs)
- timeFrame
- Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
- description
- To be summarized using descriptive statistics
- measure
- Incidence of laboratory abnormalities
- timeFrame
- Through 30-37 days following last dose of SGN-STNV; up to approximately 3 years
- description
- To be summarized using descriptive statistics
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Disease indication
* Must have disease that is relapsed or refractory or be intolerant to standard-of-care therapies and should have no appropriate standard-of-care therapeutic option.
* Non-small cell lung cancer (NSCLC)
* HER2 negative breast cancer
* Ovarian cancer
* Cervical cancer
* Endometrial cancer
* Esophageal cancer
* Gastric cancer and GEJ carcinoma
* Colorectal cancer
* Exocrine pancreatic adenocarcinoma
* Appendiceal adenocarcinoma and pseudomyxoma peritonei of unknown origin
* Participants enrolled in the following study parts should have an appropriate tumor site that satisfies the following criteria:
* Site has tumor that is not a target lesion and has not been previously irradiated (unless progression has occurred since end of radiotherapy)
* Site has tumor that is accessible for a minimally invasive biopsy that does not present a significant risk, AND
* Participant must agree to a biopsy as follows
* Disease-specific expansion cohorts: pre-treatment biopsy, unless medically infeasible following consultation with the medical monitor
* Biology expansion cohort: pretreatment biopsy (required) and additional on-treatment biopsy during Cycle 1 (unless medically infeasible following consultation with the medical monitor)
* Measurable disease per the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) at baseline
* An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
* Adequate renal, hepatic, and hematologic function
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.
* Known active central nervous system metastases
* Carcinomatous meningitis
* Previous receipt of monomethylauristatin E (MMAE)-containing drugs
* Pre-existing neuropathy ≥ Grade 2 per the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0
* Any uncontrolled ≥ Grade 3 (per the NCI CTCAE, Version 5.0) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of SGN-STNV
There are additional inclusion and exclusion criteria. The study center will determine if criteria for participation are met.References
Publications (0)
Data not yet available
No reference posted for this study.