Actively Recruiting
A Phase I/Ib Study to Assess Safety and Early Effects of ATG-037 Alone and With Pembrolizumab in Patients With Advanced Solid Tumors
Led by Antengene Therapeutics Limited · Updated on 2025-06-09
98
Participants Needed
7
Research Sites
26 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
Researchers are evaluating the safety, how the body processes and reacts to, and the early effects of ATG-037 alone and combined with Pembrolizumab in adults with locally advanced or metastatic solid tumors. This Phase I study aims to find the best dose and understand treatment impacts on patients whose cancer has progressed despite prior immune checkpoint inhibitor therapy. The trial is open-label, meaning both researchers and participants know the treatments being given, and it includes multiple centers to gather diverse data. The study has two main parts: Part I involves dose escalation of ATG-037 given orally once daily initially, then twice daily in cycles of 21 days, followed by combination therapy with Pembrolizumab administered every three weeks for up to about two years. Part II explores ATG-037 given twice daily from the start in combination with Pembrolizumab. Pembrolizumab is given as a fixed 200 mg dose every three weeks. The study includes dose escalation and expansion phases to evaluate different dosing and combinations. Participants will undergo regular monitoring including safety evaluations for adverse events up to one year after the last dose. Researchers will measure drug levels in plasma, immune activity markers, and tumor responses using standard criteria. The study assesses outcomes like dose-limiting toxicities, maximum tolerated dose, and response rates to understand treatment effects. Participants are expected to provide informed consent, meet specific health criteria, and participate in scheduled visits and assessments throughout the treatment and follow-up periods.
CONDITIONS
Brief 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 written informed consent before any study procedures
- Age 18 years or older
- Unresectable Stage III or IV melanoma with disease progression after at least one prior immune checkpoint inhibitor treatment
- At least one measurable tumor lesion per RECIST 1.1
- Estimated life expectancy of at least 12 weeks
- Acquired resistance to immune checkpoint inhibitors (objective response or stable disease over 6 months)
- ECOG performance status 0 or 1
- Females must use effective contraception until 180 days after treatment ends and not be breastfeeding
- Males must use barrier contraception during study and for 180 days after last dose
- Adequate organ function
You will not qualify if you...
- Central nervous system disease or metastases, including leptomeningeal disease or spinal cord compression
- Prior treatment with CD73 inhibitors or adenosine receptor inhibitors
- Rapidly progressive disease with progression within 90 days of prior therapy
- Recent chemotherapy, immunotherapy, anticancer agents, or investigational treatments within 28 days before study treatment
- Recent wide-field radiotherapy within 28 days or limited field radiotherapy within 14 days before study treatment
- Recent major surgery within 28 days or minor surgery within 7 days before treatment
- Unresolved toxicities greater than Grade 1 from prior treatments except alopecia and mild peripheral neuropathy
- Prior immunotherapy discontinued due to severe immune-related adverse events
- Use of 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, as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 2 years depending on treatment response and tolerability
Participants receive ATG-037 orally with dosing schedules depending on the study part, alone or in combination with Pembrolizumab. Treatment cycles are 21 days, with Pembrolizumab administered every 3 weeks for up to approximately 2 years.
Treatment visits aligned with dosing schedules, including oral medication daily and Pembrolizumab every 3 weeks
Duration - Up to 1 year after last dose
Participants are monitored for adverse events, pharmacokinetics, pharmacodynamics, and efficacy outcomes for up to one year after the last dose.
Periodic visits for safety and efficacy assessments
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
T
Ting Liu
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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