Clinical trial · Interventional
A Dose Escalation Study of SDX-7320 in Patients With Advanced Refractory or Late-Stage Solid Tumors
A Phase 1 Dose Escalation Study of SDX-7320 to Assess the Safety and Tolerability in Patients With Advanced Refractory or Late-Stage Solid Tumors
NCT02743637CI-TRIAL-00042996SDX-0101completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a Phase 1 dose escalation to assess the safety, tolerability and maximum tolerated dose of subcutaneous administered SDX-7320 in patients with advanced refractory or late-stage solid tumors.
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 |
|---|---|---|---|
| Advanced Malignancy | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
| Metastasis | — | UNRESOLVED | — |
| Neoplasm | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SDX-7320 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SDX-7320
- description
- Increasing dose cohorts, until the maximum tolerated dose (MTD) is determined.
- interventionNames
- Drug: SDX-7320
Primary outcomes (1)
- measure
- Number of participants with adverse events as a measure of safety and tolerability of SDX-7320 to find the recommended Phase II dose
- timeFrame
- Up to 30 days after last subject enrolled
Secondary outcomes (1)
- measure
- Anti-tumor activity
- timeFrame
- From the screening visit though the end of the last cycle on treatment, an expected average of 16 weeks
- description
- RECIST v1.1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Patients have at least one site of radiographically measurable disease. * Eastern Cooperative Oncology Group (ECOG) status ≤1. * Adequate renal and liver functions. * Life expectancy ≥3 months. Exclusion Criteria: * Patients that have undergone organ transplant surgery. * The patient has a known history of Hepatitis A, B, or C and is on active anti-viral therapy. * History of gastric bypass surgery or banding procedure. * Uncontrolled or refractory hypertension: systolic \>180 or diastolic \>110, or hypotension: systolic \<90 or diastolic \<50 despite medical treatment. * Participation in any other trial of an investigational agent within 30 days prior to first dose of study drug. * The resting 12-lead electrocardiogram obtained during screening shows QTc (Fridericia correction) ≥470 ms or has a congenital prolonged QT syndrome.
References
Publications (0)
Data not yet available
No reference posted for this study.