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Tests treatment safety and results for Locally Advanced or Metastatic Solid Tumors
Official title 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
ClinicalTrials.gov ID: NCT05205109
What this study is testing
What is ATG-037?
ATG-037 is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for locally advanced or metastatic solid tumors.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- There is at least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
- Estimated life expectancy of a minimum of 12 weeks.
You likely can't join if
- Primary central nervous system disease, central nervous system metastatic disease, leptomeningeal disease, metastatic cord compression or...
- 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...
- 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...
- Prior major surgery (excluding placement of vascular access) within 28 days of the first dose of study treatment or minor surgical procedures ≤7 days.
See the full eligibility criteria
- 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.
- Estimated life expectancy of a minimum of 12 weeks.
- people with acquired immune checkpoint inhibitors resistance (objective response or SD\>6 months).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at ICF signature.
- Females should be using adequate contraceptive measures until 180 days after the end of treatment, should not be breastfeeding.
- Male people 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.
- people should have adequate organ function.
- 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...
- 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...
- Prior major surgery (excluding placement of vascular access) within 28 days of the first dose of study treatment or minor surgical procedures ≤7 days.
- 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...
- 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...
- people receiving unstable or increasing doses of corticosteroids.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Sydney, New South Wales, Australia
- Benowa, Queensland, Australia
- Bedford Park, South Australia, Australia
- Frankston, Victoria, Australia
- Mount Pleasant, Western Australia, Australia
- Chongqing, Chongqing Municipality, China
- Guangzhou, Guangdong, China
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Sydney, New South Wales, Australia; Benowa, Queensland, Australia; Bedford Park, South Australia, Australia; Frankston, Victoria, Australia; Mount Pleasant, Western Australia, Australia; Chongqing, Chongqing Municipality, China and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.