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

Launched by ANTENGENE THERAPEUTICS LIMITED · Jan 11, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called ATG-037, both on its own and in combination with another medication called Pembrolizumab, for patients with advanced solid tumors. Solid tumors are abnormal growths that can occur in various parts of the body, and this study aims to assess how safe these treatments are, how the body processes them, and whether they can effectively help patients whose cancer has not responded to standard therapies.

To participate in the trial, individuals must be at least 18 years old and have a confirmed diagnosis of a solid tumor that has either come back after treatment or is resistant to it. They should also have at least one measurable tumor that can be evaluated. Participants can expect to undergo regular monitoring during the study to ensure their safety and to see how well the treatments are working. It’s important to note that certain health conditions and previous treatments may prevent someone from joining the study, so potential participants should discuss their individual situation with their doctor.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Provision of signed and dated, written informed consent prior to any study-specific procedures, sampling, and analyses.
• • 2. Aged at least 18 years as of the date of consent.
• • 3. 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.
• • 4. There is at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
• • 5. Estimated life expectancy of a minimum of 12 weeks.
• • 6. Subjects with acquired immune checkpoint inhibitors resistance (objective response or SD\>6 months).
• • 7. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature.
• • 8. Females should be using adequate contraceptive measures until 180 days after the end of treatment, should not be breastfeeding.
• • 9. Male subjects should be willing to use barrier contraception, ie condoms, for the duration of the study and 180 days after the final dose of study treatment.
• • 10. Subjects should have adequate organ function.
• Exclusion Criteria:
• • 1. Primary central nervous system disease, central nervous system metastatic disease, leptomeningeal disease, metastatic cord compression or carcinomatous meningitis.
• • 2. Prior exposure to a CD73 inhibitor/antibody or adenosine receptor inhibitor.
• • 3. Patients considered to have rapidly progressive disease (from the starting of prior line therapy to disease progression lasting no more than 90 days).
• • 4. 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.
• • 5. Radiotherapy with a wide field of radiation within 28 days, or radiotherapy with a limited field of radiation for palliation within 14 days of the first dose of study treatment. Subject must have recovered from all radiation related toxicity, not requiring corticosteroids.
• • 6. Prior major surgery (excluding placement of vascular access) within 28 days of the first dose of study treatment or minor surgical procedures ≤7 days.
• • 7. Except for alopecia, platinum-induced peripheral neurotoxicity (≤Grade 2). Any unresolved toxicities from prior therapy greater than Common Terminology Criteria for Adverse Events (CTCAE 5.0) Grade 1 at the time of ICF signature.
• • 8. Received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher irAE (except endocrine disorders that can be treated with replacement therapy) or was discontinued from that treatment due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis.
• • 9. Subjects receiving unstable or increasing doses of corticosteroids.
• • 10. As judged by the investigator, any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension defined as a blood pressure (BP) ≥160/100 mmHg despite medical therapy, unstable or uncompensated respiratory and renal disease, active bleeding diseases, allogeneic stem cell transplantation, or any solid organ transplant, etc.