Clinical trial · Interventional
First-In-Human Dose-Escalation Study of STP1002 in Patients With Advanced-Stage Solid Tumors
NCT04505839CI-TRIAL-00078492completedPhase 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 an open-label, multicenter, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics (PK) and to determine the maximum tolerated dose (MTD) of STP1002 in patients with advanced-stage solid tumors.
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 |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| STP1002 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- STP1002
- interventionNames
- Drug: STP1002
Primary outcomes (1)
- measure
- Dose limiting toxicities (DLTs)
- timeFrame
- 28 days
- description
- DLTs are defined as any of the following adverse events (AEs) that are possibly or probably related to the trial regimen occurring during Cycle 1
Secondary outcomes (2)
- measure
- Treatment-emergent adverse events (TEAEs)
- timeFrame
- 24 months
- description
- Number and severity of TEAEs, treatment-related AEs, and SAEs for all dose groups according to the NCI CTCAE v5.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Advanced-stage solid tumor (metastatic or locally advanced and unresectable) with histologically confirmed diagnosis of CRC, NSCLC, GC, RCC, or HCC * Measurable lesion(s) according to RECIST 1.1 criteria * Performance status of ≤ 2 on the Eastern Cooperative Oncology Group (ECOG) scale. * Ability to swallow capsules * Received last chemotherapy, biologic, or investigational therapy at least 4 weeks prior to first dosing of study treatment * Has received or is intolerant to all standard of care treatment options with known clinical benefit * Life expectancy of more than 3 months * Adequate hematological, hepatic and renal function * For women of childbearing potential, a negative serum pregnancy test performed within 7 days prior to start of treatment Exclusion Criteria: * Received treatment within the last 28 days with a drug that has not received regulatory approval for any indication at the time of study entry * Major surgery within the last 28 days prior to the first dose of investigational drug * Prior radiation therapy within 14 days prior to study Cycle 1 Day 1 and/or persistence of radiation-related adverse effects. * Concurrent treatment with any anticancer agent * Currently taking either strong CYP inhibitors or inducers * Known brain metastases, uncontrolled seizure disorder, or active neurologic disease * Significant cardiovascular impairment * Pregnant or nursing * Known HIV infection, active hepatitis C and/or hepatitis B infection * Known bleeding disorder or coagulopathy * Active drug or alcohol abuse or history of alcohol or drug abuse during the last two years. * Diagnosis of osteoporosis at the time of the screening * Any history of retinal pathology including diabetic retinopathy, macular degeneration, or other retinal degenerative disease
References
Publications (0)
Data not yet available
No reference posted for this study.