Clinical trial · Interventional
A Multiple Dose, Dose Escalation Trial of AEB1102 in Patients With Advanced Solid Tumors
A Phase 1 Multiple Dose, Dose Escalation Trial of AEB1102 (Co-Arg1-PEG) in Patients With Advanced Solid Tumors
NCT02561234CI-TRIAL-00120807completedPhase 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)
A first-in-human study of the safety of increasing dose levels of AEB1102 in patients with advanced cancers.
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 Cancers | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Co-ArgI-PEG | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (12)
- type
- EXPERIMENTAL
- label
- AEB1102 Dose Escalation Cohort 1
- description
- 3 patients dosed at 0.01 mg/kg until MTD determined
- interventionNames
- Drug: Co-ArgI-PEG
- type
- EXPERIMENTAL
- label
- AEB1102 Dose Escalation Cohort 2
- description
- 4 patients dosed at 0.02 mg/kg until MTD determined
- interventionNames
- Drug: Co-ArgI-PEG
- type
- EXPERIMENTAL
- label
- AEB1102 Dose Escalation Cohort 3
- description
- 4 patients dosed at 0.04 mg/kg until MTD determined
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: For patients participating in any part of the trial: * has an advanced solid tumor previously treated with, or inability to tolerate, standard therapy for the disease, or for which a standard therapy does not exist, and as such is considered a candidate for Phase 1 treatment * has adequate organ function: Hgb ≥9 g/dL; absolute neutrophil count (ANC) ≥ 1.5x109/L; plt ≥ 100,000/μL; AST and ALT \< 2.5x ULN (\< 5x ULN in patients with liver metastases); total bilirubin \< 2.0 mg/dL; serum creatinine ≤ 1.5x ULN * ECOG performance score 0-2 For patients participating in any expansion group: * has measurable disease based on RECIST 1.1 as determined by the treating investigator. Tumor lesions in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions * willing to consent for biopsy is strongly recommended but not mandatory * recovery of toxicities related to any prior treatments to at least Grade 1 by CTCAE v 4.03. Exceptions are patients with adverse event(s) that are clinically nonsignificant and/or stable on supportive therapy. For patients participating in specific expansion groups: Cutaneous Melanoma: * unresectable, locally advanced or metastatic (AJCC stage IIIB, IIIC, or IV) cutaneous malignant melanoma * relapsed or progressive disease after or unable to tolerate at least one prior systemic anticancer regimen for metastatic disease involving immunotherapy (anti-PD-1, anti-PD-L1, or anti-CTLA-4) * in tumors with a relevant BRAF mutation, relapsed, refactory, or unable to tolerate at least one prior systemic anticancer regimen for metastic disease involving a BRAF inhibitor Uveal Melanoma: * uveal melanoma at metastic stage Small Cell Lung Cancer: * extensive disease previously treated with, or inability to tolerate, platinum-based chemotherapy Exclusion Criteria: * has primary CNS malignancy * history of untreated brain mets or leptomeningeal disease or spinal cord compression * effects of prior anticancer therapy recovered to grade \< 2 * known HIV * active infection * major surgery within 2 weeks * history of another malignancy within 2 years prior
References
Publications (0)
Data not yet available
No reference posted for this study.