Phase 1: testing ATG-037 for Locally Advanced or Metastatic Solid Tumors
This is a study of ATG-037 this drug alone and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors
Official registry: https://clinicaltrials.gov/study/NCT05205109 · Antengene Therapeutics Limited · enrollment listed as 98
What this phase means
Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are ATG-037, or KEYTRUDA ®( Pembrolizumab). The registry lists allocation as na. This is a study of ATG-037 this drug alone and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors
They plan to enroll about 98 people at 8 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
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
Interventions: ATG-037, KEYTRUDA ®( Pembrolizumab)
Primary outcome (registry wording): Incidence of adverse events and server adverse events
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
- Subjects 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
Who the registry excludes
- 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)
- 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
- 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 side effects (CTCAE 5.0) Grade 1 at the time of ICF signature
- Subjects receiving unstable or increasing doses of corticosteroids
Public study contact (from the registry)
Sunny He
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
8 listed- 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)
- Beijing GoBroad Hospital — Beijing, China (recruiting)
FAQ about this NCT record
Is NCT05205109 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT05205109?
Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT05205109?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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