Locally Advanced or Metastatic Solid TumorsPhase 1NCT05205109
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
A Phase 1 study testing ATG-037 and KEYTRUDA ®( Pembrolizumab) in people with Locally Advanced or Metastatic Solid Tumors, run by Antengene Therapeutics Limited at 7 sites in 2 countries.
Trial summary
This is a study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced or Metastatic Solid Tumors
- What is being tested?
- ATG-037 and KEYTRUDA ®( Pembrolizumab)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 7 Jun 2022to 28 Feb 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Subjects with acquired immune checkpoint inhibitors resistance (objective response or SD>6 months).
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- 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 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.
- Subjects should have adequate organ function.
Who cannot join
- 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 investigational product or systemic anticancer treatment has not been cleared from the body.
- 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.
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- 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.
- 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.
- Subjects 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 uncompensated respiratory and renal disease, active bleeding diseases, allogeneic stem cell transplantation, or any solid organ transplant, etc.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Ting Liu contact
7 sites in 2 countries
Australia5 sites, 4 recruiting
- Terminated
Southern Oncology Clinical Research Unit
Bedford Park, South Australia, 5042
- Recruiting
Pindara Private Hospital
Benowa, Queensland, 4217
Mark Page, PhD, +61 7 5588 9040, HollandT@ramsayhealth.com.au
- Recruiting
Peninsula & South Eastern Haematology and Oncology Group
Frankston, Victoria, 3199
Albert Goikhman, PhD, 03 9113 1307, ag@paso.com.au
- Recruiting
One Clinical Research Pty Ltd
Mount Pleasant, Western Australia, WA6153
NA NA, management@oneclinicalresearch.com.au
- Recruiting
Calvary Mater Newcastle
Sydney, New South Wales, 2298
Janine Lomabard, MD, Janine.Lombard@calvarymater.org.au
China2 sites
- Terminated
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400000
- Terminated
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080
About this study
Official title: 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 is a study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors
Read the detailed description
This is a Phase I, 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.
Number of subjects :
- 39-51 subjects for Dose escalation phase part 1
- Maximum of 18 subjects or Dose escalation phase part 2
- 24-34 subjects per Dose expansion cohort
- Being tested
- ATG-037, KEYTRUDA ®( Pembrolizumab)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATG-037Drug
Part I : ATG-037 will be administered orally once a day (QD) on D-2, then multiple doses of ATG-037 will be administered orally BID for every day from C1D1. A treatment cycle will be defined as 21 days.
Part II: ATG-037 will be administered orally BID for every day from C1D1.
KEYTRUDA ®( Pembrolizumab)Drug
Also called MK-3475
Part I: After 2 cycles of ATG-037 monotherapy, eligible participants will receive ATG-037 combination therapy with Keytruda ®(Pembrolizumab) 200mg/Q3W fixed dose for up to 35 administrations (approximately 2 years).
Part II: Keytruda ®(Pembrolizumab) will be administered from C1.
| Study group | Role | What they receive |
|---|---|---|
| ATG-037+Keytruda(Pembrolizumab, MK-3475) | Experimental | Part I: Dose Escalation Phase of ATG-037 Monotherapy PartII: Dose Escalation Phase and Dose Expansion Phase of ATG-037 in Upfront Combination with Keytruda(Pembrolizumab, MK-3475) Receives: Drug: ATG-037; Drug: KEYTRUDA ®( Pembrolizumab) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse events and server adverse events
Will be graded according to the NCI-CTCAE Grading Scale version 5.0.
Measured: One year after last patient first dose
DLT
Number of Participants with Dose Limiting Toxicity
Measured: Up to 21 Days
MTD
Maximum tolerated dose of ATG-037
Measured: Up to 21 Days
RP2D
Recommended phase 2 dose of ATG-037
Measured: Up to 21 Days
Secondary outcomes (3)
Plasma concentration of ATG-037 and derived PK parameters
To characterize the PK/PDx of ATG-037
Measured: One year after last patient first dose
Inhibition of CD73 enzymatic activity in plasma
To evaluate the preliminary antitumor activity of ATG-037 monotherapy and combination therapy with pembrolizumab
Measured: One year after last patient first dose
ORR as per RECIST v1.1 and DOR, DCR, PFS, OS evaluated by the investigators
To evaluate the preliminary antitumor activity of ATG-037 monotherapy and combination therapy with pembrolizumab
Measured: One year after last patient first dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2022
- Study start7 Jun 2022
- Primary completion30 Aug 2027 (estimated)
- Study completion28 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Locally Advanced or Metastatic Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Antengene Therapeutics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Ganessan Kichenadasse, MD, Principal investigator, Southern Oncology Clinical Research UnitYi-Long Wu, PhD, Principal investigator, Guangdong Provincial People's HospitalQing Zhou, Principal investigator, Guangdong Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205109
- Sponsor's protocol ID
- ATG-037-001
- Other IDs
- KEYNOTE-E73
- Status last verified
- Jun 2025
- First submitted
- 11 Jan 2022
- Last updated
- 9 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05205109
- Acronym / sponsor ID
- ATG-037-001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Antengene Therapeutics LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 7 Jun 2022 (actual)
- Primary completion
- 30 Aug 2027 (estimated)
- Study completion
- 28 Feb 2028 (estimated)
- First posted
- 24 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors
Detailed description
This is a Phase I, 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.
Number of subjects :
- 39-51 subjects for Dose escalation phase part 1
- Maximum of 18 subjects or Dose escalation phase part 2
- 24-34 subjects per Dose expansion cohort
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATG-037+Keytruda(Pembrolizumab, MK-3475) | Experimental | Drug: ATG-037, Drug: KEYTRUDA ®( Pembrolizumab)Part I: Dose Escalation Phase of ATG-037 Monotherapy PartII: Dose Escalation Phase and Dose Expansion Phase of ATG-037 in Upfront Combination with Keytruda(Pembrolizumab, MK-3475) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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 investigational product or systemic anticancer treatment has not been cleared from the body.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ATG-037Part I : ATG-037 will be administered orally once a day (QD) on D-2, then multiple doses of ATG-037 will be administered orally BID for every day from C1D1. A treatment cycle will be defined as 21 days. Part II: ATG-037 will be administered orally BID for every day from C1D1. | Drug | ATG-037+Keytruda(Pembrolizumab, MK-3475) |
| KEYTRUDA ®( Pembrolizumab)Also: MK-3475Part I: After 2 cycles of ATG-037 monotherapy, eligible participants will receive ATG-037 combination therapy with Keytruda ®(Pembrolizumab) 200mg/Q3W fixed dose for up to 35 administrations (approximately 2 years). Part II: Keytruda ®(Pembrolizumab) will be administered from C1. | Drug | ATG-037+Keytruda(Pembrolizumab, MK-3475) |
Primary outcome
Incidence of adverse events and server adverse events
Time frame: One year after last patient first dose
Will be graded according to the NCI-CTCAE Grading Scale version 5.0.
DLT
Time frame: Up to 21 Days
Number of Participants with Dose Limiting Toxicity
MTD
Time frame: Up to 21 Days
Maximum tolerated dose of ATG-037
RP2D
Time frame: Up to 21 Days
Recommended phase 2 dose of ATG-037
3 secondary outcomes
Plasma concentration of ATG-037 and derived PK parameters
Time frame: One year after last patient first dose
Inhibition of CD73 enzymatic activity in plasma
Time frame: One year after last patient first dose
ORR as per RECIST v1.1 and DOR, DCR, PFS, OS evaluated by the investigators
Time frame: One year after last patient first dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ting Liu contact
Ganessan Kichenadasse, MD principal investigator
Southern Oncology Clinical Research Unit
Yi-Long Wu, PhD principal investigator
Guangdong Provincial People's Hospital
Qing Zhou principal investigator
Guangdong Provincial People's Hospital
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ATG-037 and KEYTRUDA ®( Pembrolizumab) in people with Locally Advanced or Metastatic Solid Tumors, run by Antengene Therapeutics Limited at 7 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia, China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sunny He (187 2152 1865, sunny.he@antengene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events and server adverse events (time frame: One year after last patient first dose). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2025.