NCT07822919 · Anwita Biosciences
A Study of AWT020 in Participants With Advanced Solid Tumors
What this study is about
This study is aimed at establishing the MTD and/or the RP2D for AWT020 treatment given alone and to provide safety, tolerability, effectiveness, PK, immunogenicity characteristics of AWT020.
View original scientific description
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.
Interventions
BIOLOGICAL
AWT020
Participants receiving AWT020 once every three weeks at designated dose levels
Primary outcome measures
Adverse Events (AEs) [Safety]
Time frame: Throughout the study up to 30 months
Type, incidence, and severity of Adverse Events (AEs)
Serious Adverse Events (SAEs) [Safety]
Time frame: Throughout the study up to 30 months
Type, incidence, and severity of Serious Adverse Events (SAEs)
Treatment-emergent Adverse Events (TEAEs) [Safety]
Time frame: Throughout the study up to 30 months
Type, incidence, and severity of treatment-emergent adverse events (TEAEs)
Adverse Events of Special Interest (AESIs) [Safety]
Time frame: Throughout the study up to 30 months
Type, incidence, and severity of adverse events of special interest (AESIs)
Dose-limiting Toxicities (DLTs) [Tolerability]
Time frame: Throughout the study up to 30 months
Incidence of dose-limiting toxicity (DLT)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Plantation, Florida
- Fairfax, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 23, 2026 · Source of record for eligibility and locations