Clinical trial · Interventional
A Study of AWT020 in Participants With Advanced Solid Tumors
A Phase 1 Study of AWT020 in Patients With Advanced Solid Tumors
NCT07822919CI-TRIAL-00126365recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
This study is aimed at establishing the MTD and/or the RP2D for AWT020 monotherapy and to provide safety, tolerability, efficacy, PK, immunogenicity characteristics of AWT020.
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 (Solid Tumors) | 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 (5)
- measure
- Adverse Events (AEs) [Safety]
- timeFrame
- Throughout the study up to 30 months
- description
- Type, incidence, and severity of Adverse Events (AEs)
- measure
- Serious Adverse Events (SAEs) [Safety]
- timeFrame
- Throughout the study up to 30 months
- description
- Type, incidence, and severity of Serious Adverse Events (SAEs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 years or older; able to provide written informed consent and comply with study visits and procedures. * Pathologically confirmed, unresectable advanced solid tumor. * Disease progression after at least one systemic therapy, with no beneficial standard option available or tolerated. Disease-specific prior therapy requirements apply to urothelial and renal cell carcinoma cohorts. * At least one measurable lesion by RECIST version 1.1, ECOG performance status of 0 or 1, and life expectancy of at least 3 months. * Adequate bone marrow, renal, hepatic, coagulation, and cardiac function as defined in the protocol. * Meets protocol requirements for reproductive safety and tumor tissue availability. Exclusion Criteria: * Relevant hypersensitivity or intolerance to prior immunotherapy, interleukin-2 based therapy, monoclonal antibodies, or the study treatment; or prior immunotherapy discontinued because of an immune-related adverse event. * Untreated or unstable central nervous system metastases, leptomeningeal disease, or brainstem metastases. * Clinically significant autoimmune or skin disease requiring systemic treatment; Stevens-Johnson syndrome or toxic epidermal necrolysis; or current, suspected, or steroid-treated interstitial lung disease/pneumonitis. * Unresolved toxicity from prior therapy, or recent anticancer treatment, major surgery, live vaccine, or other restricted therapy within protocol-defined washout periods. * Clinically significant cardiac, thromboembolic, cerebrovascular, gastrointestinal, bleeding, or other uncontrolled medical condition. * Active or recent severe infection. * Prior allogeneic transplantation or adoptive cellular immunotherapy; concurrent investigational therapeutic trial; or pregnancy or breastfeeding. * Another malignancy within 5 years, except permitted low-risk or in situ cancers; or any condition that increases risk, prevents consent or compliance, or could interfere with study interpretation.
References
Publications (0)
Data not yet available
No reference posted for this study.