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Advanced Solid TumorsPhase 2NCT04518137

A Study of Evaluating the Safety and Efficacy of ATG-008 for Advanced Solid Tumors (BUNCH)

A Phase 2 study testing ATG-008 30 mg, orally, QD, each 4 week (28-day) a cycle in people with Advanced Solid Tumors, run by Shanghai Antengene Corporation Limited at 4 sites in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This is a single-arm and open-label study of ATG-008 for the Treatment of Patients With advanced Solid Tumors harboring NFE 2L2, STK11, RICTOR or other specific genetic alterationts Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced Solid Tumors
What is being tested?
ATG-008 30 mg, orally, QD, each 4 week (28-day) a cycle
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
4 sitesChina
Study dates
9 Apr 2021to 30 May 2022
Phase
Phase 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Able to comprehend and provide informed consent.
  • Males or females of 18 years of age or older
  • Have histologically-proven measurable, or evaluable advanced (systemically or locally progressive), or metastatic solid tumors or the locally advanced disease is not amenable to local therapy, who have failed, or are intolerant to standard therapy or for whom no standard therapy is available. (For subjects with hepatocellular carcinoma, the diagnosis needs to be supported by dynamic computed tomography [CT]/magnetic resonance imaging, if pathological confirmation is not attainable) and agree to provide tumor tissues (within 24 months) for genomic analysis (For subjects who can provide the first NGS reports[The report was based on tumor tissues within 12 months prior to the subject's test] within 12 months prior to screening and has target gene variation(s), it is recommended to provide their tumor tissue samples to the central laboratory for testing, but the test results will not affect the inclusion/exclusion evaluation of the subjects).
  • Harboring with below specific genetic alterations:
  • NFE2L2 mutations
  • STK11 mututions
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  • RICTOR amplifications
  • Other genetic alterations maybe enrolled after discussion with Sponsor medical monitor
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • A life expectancy longer than 3 months in the opinion of the Investigator.
  • Adequate hematologic functions, as defined by: absolute neutrophil counts ≥ 1500/mm3; a hemoglobin level ≥ 9 g/dL; a platelet count ≥ 100,000/mm3.
  • Adequate hepatic function defined by: a total bilirubin level ≤ 1.5 × of upper limit of normal (ULN); aspartate transaminase and alanine transaminase levels ≤ 2.5 × ULN(AST and ALT ≤5 × ULN for subjects with liver metastasis).
  • Adequate renal function, as defined by the creatinine clearance ≥ 50 mL/minute (as calculated by the Cockcroft-Gault formula).
  • Females of child-bearing potential must have a negative pregnancy test upon entry into this study and must be willing to use highly effective birth control upon enrollment, during the Treatment Phase and for 180 days following the last dose of study drug. A female is considered of child-bearing potential following menarche and until becoming postmenopausal (no menstrual period for a minimum of 12 months) unless permanently sterile (undergone a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy).
  • If male, must be surgically sterile or willing to use highly effective birth control upon enrollment, during the Treatment Phase, and for 180 days following the last dose of study drug.
  • Child-pugh score of A or B7 (for subjects with hepatocellular carcinoma only).

Who cannot join

  • Except for hearing loss and hair loss, all toxicity from previous antitumor therapy was not recovered to≤Grade 1 (according to National Cancer Institute-Common Terminology Criteria Adverse Events [NCI-CTCAE], version 5.0).
  • Concurrent unstable or uncontrolled medical conditions, including:
  • Active systemic infections;
  • Poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg), or poor compliance with antihypertensive agents;
  • Clinically significant arrhythmia, unstable angina pectoris, congestive heart failure (Class II or IV of New York Heart Association) or acute myocardial infarction;
  • Uncontrolled diabetes or poor compliance with hypoglycemic agents (as defined: HbA1c >7%);
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  • The presence of chronically unhealed wound or ulcers;
  • Other chronic diseases, which, in the opinion of the Investigator, could compromise safety of the patient or the integrity of the study.
  • Poorly controlled pleural effusion or pericardial effusion (with clinical symptoms, fluctuating or repeated drainage of effusion, oral diuretics, etc) existed in the screening period. During the screening period, there are ascites that can be detected on physical examination, or clinical symptoms caused by ascites, or special treatment is required, such as repeated drainage, intraperitoneal drug perfusion, etc (the presence of a small amount of ascites that can only be detected by imaging examination may be considered for enrollment).
  • CNS metastases or involvement (except for the subjects with stable symptoms and no recurrence within 2 years and be likely to obtain benefit from the study determined by the investigator).
  • History of hepatic encephalopathy (only applicable to hepatocellular carcinoma subjects).
  • Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the cervix. (Subjects with a previous malignancy but without evidence of disease for ≥ 5 years can participate).
  • Females who are pregnant, lactating, or intend to become pregnant during their participation in this study.
  • Current or prior use of immunosuppressive medication within 14 days before the first dose. The following are exceptions to this criterion:
  • Intranasal, inhaled, topical steroids or local steroid injections (eg, intra-articular injection), OR
  • systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or equivalent, OR
  • steroids as premedication for hypersensitivity reactions (eg, CT scan premedication).
  • Unable to swallow ATG-008 tables.
  • Major surgery was performed within 28 days prior to screening.
  • Had anti-tumor therapy (including radiotherapy and interventional therapy, etc), systemic chemotherapy, hormone regulation therapy (such as tamoxifen), traditional Chinese medicine therapy with anti-tumor indications, or clinical trial drugs, and medical devices within 28 days prior to screening.
  • History of primary immunodeficiency or allogeneic transplantation.
  • History of human immunodeficiency virus (HIV) infection and/or acquired immunodeficiency syndrome.
  • Active hepatitis B (HBsAg active), active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test followed by a positive HCV RNA test at Screening.
  • History of interstitial lung disease.
  • Receipt of live attenuated vaccines within 30 days prior to screening. Subjects, if enrolled, should not receive live or live attenuated vaccines during the study.
  • Use/eating of drugs or food known to have potent CYP3A4 inhibitory effects within 2 weeks prior to screening, including but not limited to, atazanavir, clarithromycin, Indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, vinegar oleandomycin, voriconazole, grapefruit and grapefruit juice.
  • Use of drugs known to have strong CYP3A4 induction within 2 weeks prior to screening, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, and St. John's wort.
  • Use of drugs as CYP3A4 substrates (with stenosis treatment index) within 2 weeks prior to screening, including but not limited to dihydroergodemine, ergodemine, pimozide, astimidazole, cisapride, and terfenadine.
  • Treatment with mTOR（TORC1and/orTORC2）inhibitor, included but not limited to sirolimus, temsirolimus, everolimus, and other experimental or approved mTOR/PI3K/AKT inhibitors.
  • The subject is the investigator, sub-investigator, or anyone directly involved in the conduct of the study.
  • The investigator considers that complications or other conditions of the subject may affect the compliance with the protocol or make the subject unsuitable to participate in the study.

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Science and Peking Union Medical College

    Beijing, Beijing Municipality, 100021

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

  • Chongqing university cancer hospital

    Chongqing, Chongqing Municipality, 400030

  • The first affiliated hospital of xiamen university

    Xiamen, Fujian, 361003

Other trials in China

About this study

Official title: An Open-Label, Single-Arm Basket Study of ATG-008 for the Treatment of Patients With Advanced Solid Tumors Harboring NFE2L2, STK11, RICTOR or Other Specific Genetic Alterations

This is a single-arm and open-label study of ATG-008 for the Treatment of Patients With advanced Solid Tumors harboring NFE 2L2, STK11, RICTOR or other specific genetic alterationts

Read the detailed description

This is a single-arm and open-label study. Approximately 10-12 patients will be enrolled per each genetic alterration group in the study. ATG-008 is the monotherapy for advanced solid tumors with 30mg QD. The clinical efficacy, safety and tolerability of ATG-008 will be evaluated. Addtionalal dose levels may apply after the efficacy/safety and tolerabitly of 30mg QD has been accessed by Sponosor and study steering committee.

Being tested
ATG-008 30 mg, orally, QD, each 4 week (28-day) a cycle

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ATG-008 30 mg, orally, QD, each 4 week (28-day) a cycleDrug

    Also called ATG-008

    48 patients enrolled will be treated with 30mg QD of ATG-008, orally, each 4 week (28-day) a cycle

Study groups in NCT04518137
Study groupRoleWhat they receive
ATG-008ExperimentalEnrolled patients will be treated with ATG-008 at an oral fixed milligram (mg) dose of 30 mg QD
Receives: Drug: ATG-008 30 mg, orally, QD, each 4 week (28-day) a cycle

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ORR

    Percentage of subjects with PR, or CR

    Measured: 19 months

Secondary outcomes (4)

  1. DOR

    Duration of time from first occurrence of CR or PR until the first date that disease progression is objectively documented

    Measured: 19 months

  2. DCR

    Proportion of patients who achieve CR, PR, or SD for a minimum of 4 weeks, following the first dose of study drug (i.e., CR+PR+SD)

    Measured: 19 months

  3. OS

    Duration of time from the first dose of study drug until death due to any cause

    Measured: 19 months

  4. PFS

    Duration of time from the first dose of study drug until progression or death due to any cause

    Measured: 19 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2020
  2. Study start9 Apr 2021
  3. Primary completion30 May 2022
  4. Study completion30 May 2022

Why it stopped: Due to the low popularity of NGS testing in China and the small number of target subjects, our company decided to adjust the research and development strategy, terminate this study and not apply for new drug registration after careful consideration.

Resources

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04518137
Sponsor's protocol ID
ATG-008-AST-001
Status last verified
Jan 2023
First submitted
15 Aug 2020
Last updated
31 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing ATG-008 30 mg, orally, QD, each 4 week (28-day) a cycle in people with Advanced Solid Tumors, run by Shanghai Antengene Corporation Limited at 4 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 31 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: stopped early, as of the sponsor's last update on 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 phase mean?

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?

The study was stopped early (reason given: Due to the low popularity of NGS testing in China and the small number of target subjects, our company decided to adjust the research and development strategy, terminate this study and not apply for new drug registration after careful consideration.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR (time frame: 19 months). 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 NCT04518137.

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 31 Jan 2023.

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