A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG 037 Monotherapy and Combination Therapy With Pembrolizumab in Patients With Advanced Solid Tumors

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorAntengene Therapeutics Limited

About this trial

This is a study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors

Eligibility criteria

Qualifiers

Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.

Aged at least 18 years as of the date of consent.

Unresectable Stage III or Stage IV melanoma patients, who have had disease progression on or after at least one prior ICI containing treatment. Patients with mucosal and uveal melanoma types are to be excluded.

There is at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

Disqualifiers

Primary central nervous system disease, central nervous system metastatic disease, leptomeningeal disease, metastatic cord compression or carcinomatous meningitis.

Prior exposure to a CD73 inhibitor/antibody or adenosine receptor inhibitor.

Patients considered to have rapidly progressive disease (from the starting of prior line therapy to disease progression lasting no more than 90 days).

Prior therapy with any chemotherapy, immunotherapy, anticancer agents or investigational products from a previous clinical study within 28 days of the first dose of study treatment or within a period during which the investigational product or systemic anticancer treatment has not been cleared from the body.

Trial design

Treatments tested in this trial

  • ATG-037
  • KEYTRUDA ®( Pembrolizumab)

Treatment groups

98 Participants
are divided into 1 treatment group

Sponsors and collaborators

Antengene Therapeutics Limited

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator