AWT020 in people with advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1 dose-escalation and dose-optimization trial to determine the maximum tolerated dose and recommended phase 2 dose of AWT020 as a single-agent therapy. Participants have progressed after at least one systemic therapy and have unresectable, advanced solid tumors with no beneficial standard option available. The study uses a BOIN design to assign participants to one of four dose levels and monitor safety, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity. Treatment continues until disease progression, withdrawal, or death, with safety being the primary objective and pharmacology and potential efficacy as secondary objectives. Key assessments include safety, PK/PD, and immunogenicity, alongside tumor response per RECIST where applicable.

Why it matters

Who can join: the full rules

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 it's running

• Florida Clinical Trials Group
  Plantation, Florida, United States Recruiting
• NEXT Virginia
  Fairfax, Virginia, United States Recruiting

Study contacts

• Principal investigator: Harshad Amin, MD — Florida Clinical Trials Group
• Study coordinator: Laksmi Wilson
• Email: lwilson@anwitabio.com
• Phone: 650-600-9828

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Testing AWT020 for advanced cancer treatment

  This study is testing a new drug called AWT020 to see if it can help people with advanced cancer who haven't had success with other treatments.

  Recruiting at 4 sites Phase 1 Anwita Biosciences · South Brisbane, Queensland and 3 other locations · NCT06092580

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.