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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

Sponsor: Anwita Biosciences · Participants: 96 · Started: Sep 11, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07822919

Locations in the U.S.

FloridaFlorida Clinical Trials Group, Plantation
VirginiaNEXT Virginia, Fairfax

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.