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A Study of AWT020 in Participants With Advanced Solid Tumors
RecruitingPhase 1
A Phase 1 Study of AWT020 in Patients With Advanced Solid Tumors
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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.
About the study
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.
What is being tested
- AWT020 (biological)
Sponsor: Anwita Biosciences · Participants: 96 · Started: Sep 11, 2026
Contact the study team
- Laksmi Wilson · Phone: 650-600-9828
Official record on ClinicalTrials.gov — NCT07822919
Locations in the U.S.
| Florida | Florida Clinical Trials Group, Plantation |
| Virginia | NEXT Virginia, Fairfax |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.