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NCT07822919From ClinicalTrials.govRecruiting

A Study of AWT020 in Participants With Advanced Solid Tumors

A Phase 1 Study of AWT020 in Patients With Advanced Solid Tumors

  • Advanced Cancers (Solid Tumors)

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Anwita Biosciences
Enrolment target
96
Started
11 September 2026
Main results due
January 2029
Study sites
2
Registry updated
23 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(2)

  • Florida Clinical Trials Group

    Plantation, Florida, United States

    Recruiting

  • NEXT Virginia

    Fairfax, Virginia, United States

    Recruiting

Showing 2 of 2 sites. 2 of the 2 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07822919. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study of AWT020 in Participants With Advanced Solid Tumors | Trialion