Actively Recruiting
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
Led by Antengene Therapeutics Limited · Updated on 2025-06-09
98
Participants Needed
7
Research Sites
298 weeks
Total Duration
On this page
Sponsors
A
Antengene Therapeutics Limited
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors
CONDITIONS
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent before any study procedures
- At least 18 years old at consent
- Unresectable Stage III or IV melanoma with disease progression after prior immune checkpoint inhibitor treatment
- At least one measurable lesion by RECIST 1.1
- Estimated life expectancy of at least 12 weeks
- Acquired resistance to immune checkpoint inhibitors (response or stable disease >6 months)
- ECOG performance status 0 or 1 at consent
- Females must use adequate contraception until 180 days after treatment and not be breastfeeding
- Males must use barrier contraception during study and 180 days after final dose
- Adequate organ function
You will not qualify if you...
- Primary central nervous system disease or metastases, leptomeningeal disease, metastatic cord compression, or carcinomatous meningitis
- Prior exposure to CD73 or adenosine receptor inhibitors
- Rapidly progressive disease lasting 90 days or less from prior therapy start
- Chemotherapy, immunotherapy, anticancer agents or investigational product within 28 days before study treatment
- Radiotherapy within 28 days for wide field or 14 days for limited field, with recovery from toxicity
- Major surgery within 28 days or minor surgery within 7 days before study treatment
- Unresolved toxicities from prior therapy greater than CTCAE Grade 1 except alopecia or platinum-induced peripheral neuropathy Grade 2 or less
- Prior immunotherapy discontinued due to Grade 3 or higher immune-related adverse events (except manageable endocrine disorders) or Grade 2 myocarditis or recurrent Grade 2 pneumonitis
- Unstable or increasing corticosteroid doses
- Severe or uncontrolled systemic diseases including uncontrolled hypertension, unstable respiratory or renal disease, active bleeding, stem cell or organ transplant history
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
Calvary Mater Newcastle
Sydney, New South Wales, Australia, 2298
Actively Recruiting
2
Pindara Private Hospital
Benowa, Queensland, Australia, 4217
Actively Recruiting
3
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, Australia, 5042
Terminated
4
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, Australia, 3199
Actively Recruiting
5
One Clinical Research Pty Ltd
Mount Pleasant, Western Australia, Australia, WA6153
Actively Recruiting
6
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, China, 400000
Terminated
7
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China, 510080
Terminated
Research Team
S
Sunny He
CONTACT
T
Ting Liu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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