Clinical trial · Interventional
Study to Assess an Anti-Trop2 Antibody Drug Conjugate in Relapsed or Refractory Solid Tumors
A Phase 1B, Dose-Escalation Study of the Safety and Preliminary Efficacy of an Anti-Trop2 Antibody Drug Conjugate (STI-3258) in Patients With Relapsed or Refractory Solid Tumors
NCT05060276CI-TRIAL-00063449withdrawnPhase 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): Protocol changed to Phase 2
Summary
Brief summary (as posted)
This is a phase 1b, open-label, dose-escalation study o STI-3258 administered intravenously in subjects with relapsed or refractory solid tumors.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Relapsed Solid Neoplasm | Solid Neoplasm | CURATED_BROADER | 0.78 |
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| STI-3258 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- STI-3258
- description
- Intravenous infusion to be given with prophylaxis for infusion reactions, evaluating up to five dose cohorts including: 8 mg/kg, 12 mg/kg, 16 mg/kg, 20 mg/kg, and 24 mg/kg.
- interventionNames
- Biological: STI-3258
Primary outcomes (7)
- measure
- Incidence of adverse events by type, frequency, severity, and causality (safety)
- timeFrame
- Baseline through study completion at up to approximately 24 months
- description
- Safety as assessed by incidence of adverse events (AEs) by type, frequency, severity, and causality
- measure
- Incidence of treatment-emergent adverse events by type, frequency, severity, and causality (safety)
- timeFrame
- Baseline through study completion at up to approximately 24 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed advanced cancer that is relapsing or refractory to at least one prior treatment and not a candidate for other treatments or is intolerant to established treatments. * At least one measurable disease per Response Evaluation Criteria in Solid Tumors v. 1.1 (RECIST 1.1). * Eastern Cooperative Oncology Group Performance Status ≤ 2. * Must have a life expectancy of ≥ 6 months. * Must have adequate bone marrow, hepatic and renal function as assessed by specific laboratory tests. * Must be recovered ≤ Grade 1 from acute toxicities from previous therapies, excluding alopecia and vitiligo. * Has not had prior treatment within 2 weeks of screening with high dose corticosteroids. * Be willing and able to comply with the study schedule and all study requirements. * Willing to follow all contraception guidelines. Exclusion Criteria: * Previous treatment with any systemic therapy or investigational drug within 2 weeks of the first dose of study drug. * Currently participating in any other interventional clinical study. * Has a diagnosis of other malignancies if the malignancy has required therapy within the last 3 years or is not in complete remission. * Has presence of bulky disease defined as any mass \> 7 cm in greatest dimension will trigger a discussion with the medical monitor. * Has left ventricular ejection fraction (LVEF) \< 40%. * New York Heart Association (NYHA) Class ≥ 3. * Has prolonged QTcF interval on an electrocardiogram. * Has spinal cord compression or clinically active brain metastases. * Has a history of Sacituzumab govitecan treatment. * History of anaphylactic reaction to irinotecan or ≥ Grade 3 toxicity to prior irinotecan treatment. * Has active or prior COVID-19 infection, with symptoms presenting within 4 weeks of the first dose of study drug. * Has an active bacterial, viral, or fungal infection. * Is currently pregnant or breast feeding or planning on either during the study. * Has chronic or moderate chronic obstructive pulmonary disease or other chronic respiratory conditions unless receiving treatment and stable for 3 months prior to screening. * Has known HIV or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or C. * Has any significant medical condition, abnormality, or psychiatric illness that would prevent study participation.
References
Publications (0)
Data not yet available
No reference posted for this study.