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

• Status: Recruiting
• Trial end date: 2022-09-30
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Antengene Corporation Limited

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(AST and ALT ≤5 × ULN for subjects with liver metastasis).

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.