NCT05205109 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
| NCT ID | NCT05205109 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Antengene Therapeutics Limited |
| Condition | Locally Advanced or Metastatic Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 98 participants |
| Start Date | 2022-06-07 |
| Primary Completion | 2027-08-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 98 participants in total. It began in 2022-06-07 with a primary completion date of 2027-08-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors
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.
Contact & Investigator
Ganessan Kichenadasse, MD
PRINCIPAL INVESTIGATOR
Southern Oncology Clinical Research Unit
Frequently Asked Questions
Who can join the NCT05205109 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locally Advanced or Metastatic Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05205109 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05205109 currently recruiting?
Yes, NCT05205109 is actively recruiting participants. Contact the research team at sunny.he@antengene.com for enrollment information.
Where is the NCT05205109 trial being conducted?
This trial is being conducted at Sydney, Australia, Benowa, Australia, Bedford Park, Australia, Frankston, Australia and 3 additional locations.
Who is sponsoring the NCT05205109 clinical trial?
NCT05205109 is sponsored by Antengene Therapeutics Limited. The principal investigator is Ganessan Kichenadasse, MD at Southern Oncology Clinical Research Unit. The trial plans to enroll 98 participants.