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RecruitingLast updated: 27 March 2024

This study is evaluating a new drug at different dose levels in people with locally advanced or metastatic solid cancerA Phase 1/2, First-in-human, Open-label Study of Single-agent AWT020 in Patients With Progressive Locally Advanced or Metastatic Cancer

Clinical summary

Summary

This study will enrol people with locally advanced or metastatic cancer who have failed standard therapy. Participants enrolled into this study will be assigned a dose level and receive the study drug, called AWT020 via intravenous infusion (IV) at a regular interval. 

Conditions

This trial is treating patients with locally advanced or metastatic solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Anwita Biosciences

Scientific Title

A Phase 1/2, First-in-human, Open-label Study of Single-agent AWT020 in Patients With Progressive Locally Advanced or Metastatic Cancer

Eligibility

Inclusion

  • Subject has provided informed consent prior to initiation of any study specific activities or procedures.
  • Subject must be ≥ 18 years of age or per local regulation.
  • Subjects must have a histological diagnosis of solid tumors (carcinoma or sarcoma) or malignant lymphoma, either progressive locally advanced not amenable to local therapy or metastatic, which is refractory, ineligible (in the opinion of the Investigator) or intolerant to standard therapy. Subjects with hepatocellular carcinoma must be diagnosed with dynamic CT or MRI if no tissue diagnosis is available.
  • Subject must have performance status of 0, or 1 on the ECOG performance scale.
  • Subject with adequate organ function.
  • Life expectancy is longer than three months.
  • Subject must be able to receive effective contraceptive measures.

Exclusion

  • Subject is allergic or intolerant to either anti-PD1 or interleukin-2 therapy.
  • Subject has received prior immune-check point inhibitors and was discontinued due to greater than grade 3 toxicities.
  • Subject is receiving other investigational agent or device.
  • Subject has active infection, uncontrolled hypertension, unstable angina, uncontrolled diabetes mellitus, recent myocardial infarction, and congestive heart failure with ejection fraction less than 50%.
  • Subject has prior allogeneic stem cell or bone marrow transplant or organ transplant.
  • Subject has active central nervous system (CNS) metastases or carcinomatous meningitis.
  • Subject with HIV whose viral load is > 400 copies/mL or CD4+ T cell counts are < 350 cells/µL.
  • Subject has baseline corrected QT interval (QTc) longer than 480 ms by Fridericia formula.
  • Subject is pregnant or breast-feeding.
  • Subject has received live virus vaccine within 28 days prior to the first dose of study.
  • Any other conditions that might compromise the safety of the subject or the integrity of the study.

Inclusion

  • You have had treatment, but your cancer has come back.
  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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Recruiting hospitals

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