Advanced Solid TumorPhase 1/2NCT04337463
ATG-008 Combined With Toripalimab in Advanced Solid Tumors
A Phase 1/2 study testing ATG-008 and Toripalimab in people with Advanced Solid Tumor, run by Sichuan University at 2 sites in China.
Trial summary
This is an open-label, single-arm study with dose-escalation and expansion phases to access ATG-008 combined with Toripalimab in patients with advanced solid tumors. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Advanced Solid Tumor
- What is being tested?
- ATG-008 and Toripalimab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesChina
- Study dates
- 23 Apr 2020to 1 Dec 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Know and voluntarily sign informed consent.
- Age 18-70 years old (including 18 and 70 years old), weight ≥45 Kg.
- At least one measurable lesion according to the RECIST 1.1 and RANO evaluation criteria.
- ECOG performance status score is 0 or 1.
- Blood chemistry test results, meet the following results:
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × normal upper limit (ULN)
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- Total bilirubin ≤ 1.5 × ULN
- Serum albumin> 29 g / L
- Creatinine ≤ 1.5 × ULN or 24-hour serum creatinine clearance ≥ 50 mL / min
- Lipase and amylase ≤ 2 × ULN.
- Adequate bone marrow function and meets the following results:
- Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L
- Platelets ≥ 75 × 10^9 / L
- Hemoglobin ≥ 90 g / L.
- Except for hearing loss and hair loss, all toxicity caused by previous anti-tumor therapy must have returned to ≤ Grade 1 (according to NCI-CTCAE version 5.0).
- Life expectancy is longer than 3 months.
Who cannot join
- Have a history of hepatic encephalopathy.
- Have a thyroid disorder with a clinically significant thyroid dysfunction judged by the investigator (not applicable for thyroid cancer in dose expansion phase).
- Active or history of upper gastrointestinal bleeding, ulcers, or esophageal varices with bleeding within 6 months.
- Have a history of HIV infection and/or acquired immunodeficiency syndrome
- Major surgery has been performed within 4 weeks before the first dose, or is expected during the study period.
- Have a history of organ transplantation (eg., liver transplantation).
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- Poorly-controlled pleural or pericardial effusion during the screening period.
- Other primary malignancies occurred within 5 years before the first administration of the study drug with the exception of locally curable malignancies
- Suffering from active or previously recurring autoimmune diseases or under such a risk.
- Systemically immunosuppressive drugs are currently used within 14 days of the first dose.
- The investigator considers that the complications or other situations of the subject may affect compliance with the protocol, or are not suitable for participation in this study.
- Subjects with diabetes or glycated hemoglobin (HbA1c)> 7%.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
West China of Sichuan University
Chengdu, Sichuan, 610000
Li Zheng, +86 028-85423655, lzheng2005618@163.com
- Recruiting
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality
Iris Li
About this study
Official title: An Open, Dose-escalation and Expansion Study With a Dual TORC1/2 Inhibitor of ATG-008 Combined With PD-1 Antibody of Toripalimab in Advanced Solid Tumors
This is an open-label, single-arm study with dose-escalation and expansion phases to access ATG-008 combined with Toripalimab in patients with advanced solid tumors.
- Conditions
- Advanced Solid Tumor
- Being tested
- ATG-008, Toripalimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ATG-008Drug
Tablet
ToripalimabDrug
IV infusion
| Study group | Role | What they receive |
|---|---|---|
| ATG-008 and Toripalimab | Experimental | Toripalimab will be combined with ATG-008. Receives: Drug: ATG-008; Drug: Toripalimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
MTD
Maximum Tolerated Dose
Measured: Within 21 days after dosing
RP2D
Recommended phase 2 dose
Measured: Within 21 days after dosing
ORR
Overall Response Rate
Measured: Through study completion (approximately 2 years)
Secondary outcomes (6)
Cmax
Peak Plasma Concentration (Cmax)
Measured: Day 1 - Day 15
AUC
Area under the plasma concentration versus time curve (AUC)
Measured: Day 1 - Day 15
DOR
Duration from the first observation of at least PR to time of disease progression, or deaths due to disease progression, whichever occurs first.
Measured: 12 months
DCR
Disease Control Rate (DCR=CBR+Stable Disease[SD; for a minimum of 12 weeks])
Measured: 12 months
PFS
Duration from start of study treatment to PD or death (regardless of cause), whichever comes first
Measured: 12 months
OS
The estimates of Kaplan-Meier
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2020
- Study start23 Apr 2020
- Primary completion1 May 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Advanced Solid TumorStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sichuan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Zheng, Sichuan University
- Investigators
- Li Zheng, Principal investigator, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04337463
- Sponsor's protocol ID
- ATG-008-HX-001
- Status last verified
- May 2021
- First submitted
- 21 Mar 2020
- Last updated
- 17 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shu P, Li X, Zhou Q, Li G, Zhang K, Yuan L, Liu Y, Li Q, Wang Y, Xie H, Zheng L. Multicenter phase 1/2 study of onatasertib, a dual TORC1/2 inhibitor, combined with the PD-1 antibody toripalimab in advanced solid tumors. Signal Transduct Target Ther. 2025 Jun 25;10(1):198. doi: 10.1038/s41392-025-02281-0.
PubMed 40555721
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Dose-escalation and Expansion Study With a Dual TORC1/2 Inhibitor of ATG-008 Combined With PD-1 Antibody of Toripalimab in Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04337463
- Acronym / sponsor ID
- ATG-008-HX-001
- Conditions
- Advanced Solid Tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sichuan UniversityUniversity, hospital or other
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 7 Apr 2020 (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 an open-label, single-arm study with dose-escalation and expansion phases to access ATG-008 combined with Toripalimab in patients with advanced solid tumors.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATG-008 and Toripalimab | Experimental | Drug: ATG-008, Drug: ToripalimabToripalimab will be combined with ATG-008. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Know and voluntarily sign informed consent.
- Age 18-70 years old (including 18 and 70 years old), weight ≥45 Kg.
- At least one measurable lesion according to the RECIST 1.1 and RANO evaluation criteria.
- ECOG performance status score is 0 or 1.
- Blood chemistry test results, meet the following results:
Key exclusion criteria (12 listed)
- Have a history of hepatic encephalopathy.
- Have a thyroid disorder with a clinically significant thyroid dysfunction judged by the investigator (not applicable for thyroid cancer in dose expansion phase).
- Active or history of upper gastrointestinal bleeding, ulcers, or esophageal varices with bleeding within 6 months.
- Have a history of HIV infection and/or acquired immunodeficiency syndrome
- Major surgery has been performed within 4 weeks before the first dose, or is expected during the study period.
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-008Tablet | Drug | ATG-008 and Toripalimab |
| ToripalimabIV infusion | Drug | ATG-008 and Toripalimab |
Primary outcome
MTD
Time frame: Within 21 days after dosing
Maximum Tolerated Dose
RP2D
Time frame: Within 21 days after dosing
Recommended phase 2 dose
ORR
Time frame: Through study completion (approximately 2 years)
Overall Response Rate
6 secondary outcomes
Cmax
Time frame: Day 1 - Day 15
AUC
Time frame: Day 1 - Day 15
DOR
Time frame: 12 months
DCR
Time frame: 12 months
PFS
Time frame: 12 months
OS
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Derived from this study: PubMed 40555721Shu P, Li X, Zhou Q, Li G, Zhang K, Yuan L, Liu Y, Li Q, Wang Y, Xie H, Zheng L. Multicenter phase 1/2 study of onatasertib, a dual TORC1/2 inhibitor, combined with the PD-1 antibody toripalimab in advanced solid tumors. Signal Transduct Target Ther. 2025 Jun 25;10(1):198. doi: 10.1038/s41392-025-02281-0.
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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. This study is not recruiting at the moment.
Li Zheng principal investigator
West China Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ATG-008 and Toripalimab in people with Advanced Solid Tumor, run by Sichuan University at 2 sites in China.
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 16 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Zheng (+86 028-85423655, lzheng2005618@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MTD (time frame: Within 21 days after dosing). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04337463, which also lists 1 linked publication.
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 17 May 2021.