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

NCT04518137 | Terminated Phase 2

• 1 other identifier: ATG-008-AST-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 4

Brief 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

Conditions

Advanced Solid Tumors

Outcome Measures

Primary Outcomes (1)

• ORR

  Percentage of subjects with PR, or CR

  19 months

Secondary Outcomes (4)

• DOR

  19 months

• DCR

  19 months

• OS

  19 months

• PFS

  19 months

Study Arms (1)

ATG-008

EXPERIMENTAL

Enrolled patients will be treated with ATG-008 at an oral fixed milligram (mg) dose of 30 mg QD

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

Interventions

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

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

Also known as: ATG-008

ATG-008

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to comprehend and provide informed consent.
• Males or females of 18 years of age or older
• Harboring with below specific genetic alterations:
• NFE2L2 mutations
• STK11 mututions
• 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).

You may not qualify if:

• 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%);
• 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

Sponsors & Collaborators

• Shanghai Antengene Corporation Limited: lead

Study Sites (4)

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

Beijing, Beijing Municipality, 100021, China

Location

Chongqing university cancer hospital

Chongqing, Chongqing Municipality, 400030, China

Location

The first affiliated hospital of xiamen university

Xiamen, Fujian, 361003, China

Location

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Study Officials

• Yuankai Shi, MD; PhD

  Chinese Academay of Medical Science and Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 15, 2020
• First Posted: August 19, 2020
• Study Start: April 9, 2021
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: January 31, 2023

Record last verified: 2023-01

Locations

CN (4)