Clinical Trials /

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

NCT04518137

Description:

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

Related Conditions:
  • Malignant Solid Tumor
Recruiting Status:

Not yet recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: ATG-008-AST-001
  • NCT ID: NCT04518137

Conditions

  • Advanced Solid Tumors

Interventions

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

Purpose

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

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.
    

Trial Arms

NameTypeDescriptionInterventions
ATG-008ExperimentalEnrolled patients will be treated with ATG-008 at an oral fixed milligram (mg) dose of 30 mg QD
  • ATG-008 30 mg, orally, QD, each 4 week (28-day) a cycle

Eligibility Criteria

        Inclusion Criteria:

          1. Males or females of 18 years of age or older

          2. 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 patients 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 fresh tumor tissues for genomic analysis.

          3. Harboring with below specific genetic alterations:

               1. NFE2L2 mutations

               2. STK11 mututions

               3. RICTOR amplifications

               4. Other genetic alterations maybe enrolled after discussion with Sponsor medical
                  monitor

          4. Eastern Cooperative Oncology Group (ECOG) performance status of < 2 at the screening.

          5. Able to comprehend and provide informed consent.

          6. A life expectancy longer than 3 months in the opinion of the Investigator.

          7. Adequate hematologic functions, as defined by: absolute neutrophil counts ≥ 1500/mm3;
             a hemoglobin level ≥ 9 g/dL; a platelet count ≥ 100,000/mm3.

          8. 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.

          9. Adequate renal function, as defined by the creatinine clearance ≥ 50 mL/minute (as
             calculated by the Cockcroft-Gault formula).

         10. 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).

         11. 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.

        Exclusion Criteria:

          1. Persistent ≥ Grade 2 toxicities from prior therapies, with the exception of alopecia
             of any grade, Grade ≤ 2 peripheral neuropathy, and laboratory values listed per the
             inclusion criteria.

          2. Concurrent unstable or uncontrolled medical conditions, including:

               1. Active systemic infections;

               2. Poorly controlled hypertension (systolic blood pressure ≥ 150 mmHg or diastolic
                  blood pressure ≥ 100 mmHg), or poor compliance with antihypertensive agents;

               3. Clinically significant arrhythmia, unstable angina pectoris, congestive heart
                  failure (Class II or IV of New York Heart Association) or acute myocardial
                  infarction;

               4. Uncontrolled diabetes or poor compliance with hypoglycemic agents (as defined:
                  HbA1c >7%);

               5. The presence of chronically unhealed wound or ulcers;

               6. Other chronic diseases, which, in the opinion of the Investigator, could
                  compromise safety of the patient or the integrity of the study.

          3. Any concurrent malignancy other than basal cell carcinoma or carcinoma in situ of the
             cervix. (Patients with a previous malignancy but without evidence of disease for ≥ 5
             years are allowed to participate).

          4. Females who are pregnant, lactating, or intend to become pregnant during their
             participation in this study.

          5. Known history of human immunodeficiency virus infection.

          6. Current or prior use of immunosuppressive medication within 14 days before the first
             dose. The following are exceptions to this criterion:

               1. Intranasal, inhaled, topical steroids or local steroid injections (eg,
                  intra-articular injection), OR

               2. systemic corticosteroids at physiologic doses not to exceed 10 mg/day of
                  prednisone or equivalent, OR

               3. steroids as premedication for hypersensitivity reactions (eg, CT scan
                  premedication).

          7. History of primary immunodeficiency or allogeneic transplantation.

          8. 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.

          9. The patient is the Investigator, sub-investigator or anyone directly involved in the
             conduct of the study.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:ORR
Time Frame:19 months
Safety Issue:
Description:Percentage of subjects with PR, or CR

Secondary Outcome Measures

Measure:DOR
Time Frame:19 months
Safety Issue:
Description:Duration of time from first occurrence of CR or PR until the first date that disease progression is objectively documented
Measure:DCR
Time Frame:19 months
Safety Issue:
Description: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)
Measure:OS
Time Frame:19 months
Safety Issue:
Description:Duration of time from the first dose of study drug until death due to any cause
Measure:PFS
Time Frame:19 months
Safety Issue:
Description:Duration of time from the first dose of study drug until progression or death due to any cause

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Shanghai Antengene Corporation Limited

Last Updated

August 15, 2020