Clinical trial · Interventional
A Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK114
A Phase 1a, Multicenter, Open-label, Dose-escalation Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Activity of AK114 in Subjects With Advanced or Metastatic Solid Tumors
NCT05200273CI-TRIAL-00056051unknownPhase 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 Phase 1 study to evaluate the safety, tolerability, PK, immunogenicity, pharmacodynamics, and preliminary antitumor activity of AK114.
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 |
|---|---|---|---|
| Advanced or Metastatic Solid Tumors | — | UNRESOLVED | — |
| Malignancy | Malignant Neoplasm | ALIAS | 0.90 |
| Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AK114 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention/treatment
- description
- Experimental
- interventionNames
- Drug: AK114
Primary outcomes (2)
- measure
- Incidence of adverse events (AEs)
- timeFrame
- From the time of informed consent signed through to 90 days after last dose of study drug
- description
- An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study drug, whether or not considered related to the study drug.
- measure
- Number of participants with a Dose Limiting Toxicity (DLTs)
- timeFrame
- Within the first 28 days after receiving the first dose of study drug
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Written and signed informed consent 2. Age ≥ 18 3. Subjects must have histologically or cytologically confirmed advanced or metastatic solid tumor 4. Subject must have at least one measurable lesion according to RECIST v1.1 5. Eastern Cooperative Oncology Group (ECOG) performance status score ≤ 1 6. At the time of Day 1 of the study, subjects with central nervous system (CNS) metastases must have been treated 7. Available archived tumor tissue sample (block or a minimum of 10 unstained slides of formalin-fixed paraffin-embedded tissues) to allow for correlative biomarker studies 8. Subjects may opt to provide two fresh biopsy samples (pretreatment and on treatment), where clinically appropriate 9. Adequate organ function 10. Use acceptable method of contraception from screening, and must agree to continue for 120 days after the final dose of investigational product Exclusion Criteria: 1. History of severe hypersensitivity reactions to other monoclonal antibodies 2. History or concurrent gastrointestinal perforation, surgery and wound healing complications, hemorrhage events 3. Patients with clinically significant cardiovascular disease 4. Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of investigational product administration 5. Active or prior documented autoimmune disease within the past 2 years 6. History of primary immunodeficiency 7. History of organ transplant or hematopoietic stem cell that requires use of immunosuppressive medications 8. Known allergy or reaction to any component of the investigational product formulation. 9. History of interstitial lung disease or noninfectious pneumonitis except for those induced by radiation therapies. 10. Prior treatment with canakinumab.
References
Publications (0)
Data not yet available
No reference posted for this study.