Clinical trial · Interventional
Phase 1 Study of AWT020 in Advanced Cancer
A Phase 1/2, First-in-human, Open-label Study of Single-agent AWT020 in Patients With Progressive Locally Advanced or Metastatic Cancer
NCT06092580CI-TRIAL-00094382recruitingPhase 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 aims of this clinical trial are (1) to assess the safety of AWT020 at different dose levels; (2) to determine the pharmacokinetics and pharmacodynamics of AWT020 in subjects with locally advanced or metastatic cancer who have failed standard therapy.
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 Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AWT020 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- AWT020
- description
- Participants receiving intravenous infusion of AWT020
- interventionNames
- Biological: AWT020
Primary outcomes (1)
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE 5.0
- timeFrame
- From the first infusion up to 90 days after last infusion
- description
- The overall safety of AWT020 in treated subjects
Secondary outcomes (8)
- measure
- Cmax of AWT020
- timeFrame
- 30 minutes after the first infusion in cycle 1 and cycle 2
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject has provided informed consent prior to initiation of any study specific activities or procedures. * Subject must be ≥ 18 years of age or per local regulation. * Subjects must have a histological diagnosis of solid tumors (carcinoma or sarcoma) or malignant lymphoma, either progressive locally advanced not amenable to local therapy or metastatic, which is refractory, ineligible (in the opinion of the Investigator) or intolerant to standard therapy. Subjects with hepatocellular carcinoma must be diagnosed with dynamic CT or MRI if no tissue diagnosis is available. * Subject must have performance status of 0, or 1 on the ECOG performance scale. * Subject with adequate organ function. * Life expectancy is longer than three months. * Subject must be able to receive effective contraceptive measures. Exclusion Criteria: * Subject is allergic or intolerant to either anti-PD1 or interleukin-2 therapy. * Subject has received prior immune-check point inhibitors and was discontinued due to greater than grade 3 toxicities. * Subject is receiving other investigational agent or device. * Subject has active infection, uncontrolled hypertension, unstable angina, uncontrolled diabetes mellitus, recent myocardial infarction, and congestive heart failure with ejection fraction less than 50%. * Subject has prior allogeneic stem cell or bone marrow transplant or organ transplant. * Subject has active central nervous system (CNS) metastases or carcinomatous meningitis. * Subject with HIV whose viral load is \> 400 copies/mL or CD4+ T cell counts are \< 350 cells/µL. * Subject has baseline corrected QT interval (QTc) longer than 480 ms by Fridericia formula. * Subject is pregnant or breast-feeding. * Subject has received live virus vaccine within 28 days prior to the first dose of study. * Any other conditions that might compromise the safety of the subject or the integrity of the study.
References
Publications (0)
Data not yet available
No reference posted for this study.