Assessing ATG-037 and Pembrolizumab for Advanced Solid Tumors

A Phase I/Ib, Multi-center, Open-label, and Dose-finding Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG-037 Monotherapy and Combination Therapy With Pembrolizumab in Patients With Locally Advanced or Metastatic Solid Tumors

This study is testing a new treatment called ATG-037, both alone and with Pembrolizumab, to see if it can help people with advanced solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 98 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Antengene Corporation (Industry-sponsored)
• Drugs / interventions: chemotherapy, immunotherapy, radiation, Pembrolizumab
• Locations: 7 sites (Sydney, New South Wales and 6 other locations)
• Trial ID: NCT05205109 on ClinicalTrials.gov

What this trial studies

This Phase I, multi-center, open-label study evaluates the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of ATG-037 both as a monotherapy and in combination with Pembrolizumab in patients with locally advanced or metastatic solid tumors. The study involves a dose-finding approach with an initial dose escalation phase followed by a dose expansion cohort. Participants will be closely monitored for treatment responses and side effects to determine the optimal dosing and effectiveness of the therapies.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed solid tumors that have relapsed or are refractory to standard treatments.

Not a fit: Patients with solid tumors that are not measurable or those who have not previously received immune checkpoint inhibitors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors that are resistant to standard therapies.

How similar studies have performed: Other studies involving combination therapies with immune checkpoint inhibitors have shown promising results, suggesting potential for success in this approach.

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.

Where this trial is running

Sydney, New South Wales and 6 other locations

• Calvary Mater Newcastle — Sydney, New South Wales, Australia (Recruiting)
• Pindara Private Hospital — Benowa, Queensland, Australia (Recruiting)
• Southern Oncology Clinical Research Unit — Bedford Park, South Australia, Australia (Terminated)
• Peninsula & South Eastern Haematology and Oncology Group — Frankston, Victoria, Australia (Recruiting)
• One Clinical Research Pty Ltd — Mount Pleasant, Western Australia, Australia (Recruiting)
• Chongqing Cancer Hospital — Chongqing, Chongqing Municipality, China (Terminated)
• Guangdong Provincial People's Hospital — Guangzhou, Guangdong, China (Terminated)

Study contacts

• Principal investigator: Ganessan Kichenadasse, MD — Southern Oncology Clinical Research Unit
• Study coordinator: Sunny He

Conditions Locally Advanced or Metastatic Solid Tumors