Clinical trial · Interventional
Study of SGR-3515 In Participants With Advanced Solid Tumors.
A First-In-Human, Phase 1, Dose Escalation Study of SGR-3515 In Participants With Advanced Solid Tumors.
NCT06463340CI-TRIAL-00092990recruitingPhase 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)
The purpose of this study is to learn about the effects of a new study drug, called SGR-3515 that may be a treatment for advanced 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 |
|---|---|---|---|
| SGR-3515 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- 28-day treatment cycle.
- interventionNames
- Drug: SGR-3515
Primary outcomes (4)
- measure
- Incidence and severity of adverse events (AEs)
- timeFrame
- Day 1 to 28 days after the last dose of SGR-3515.
- description
- Incidence and severity of adverse events (AEs) per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) 5.0 and changes in hematology and chemistry values, vital signs, electrocardiograms (ECGs); and dose interruptions, dose reductions, dose delays and study drug discontinuation due to AEs.
- measure
- Incidence of Dose Limiting Toxicities (DLTs)
- timeFrame
- Day 1 to Day 28 of the first 28-day dosing cycle.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of advanced/metastatic solid tumor * Measurable disease per RECIST version 1.1 * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Participant must understand and sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures * Adequate bone marrow and organ function * Women of child-bearing potential (WOCBP) or males must agree to use highly effective contraception for the duration of study and for 90 days after the last dose of study drug Exclusion Criteria * Participants with primary Central Nervous System (CNS tumors). * Participant has received prior systemic anti-cancer treatments or other investigational agents ≤ 21 days of first dose of study drug, or 5 half-lives, whichever is shorter * Participant who has received definitive local control radiation (any dose greater than 50 Gy) \< 42 days prior to the first dose of study drug. * Participant who has received major surgeries ≤ 21 days prior to first dose of study drug * Participants who have not recovered to Grade 1 or baseline levels from toxicity or adverse events related to prior treatment for their cancer, excluding Grade 2 alopecia, peripheral neuropathy and ototoxicity. * Participant who has another clinically significant invasive malignancy, as determined by the investigator, ≤ 2 years prior to the first dose
References
Publications (0)
Data not yet available
No reference posted for this study.