ATG-008 Combined With Toripalimab in Advanced Solid Tumors

Advanced Solid Tumor Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04337463
• Other study ID #: ATG-008-HX-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: April 23, 2020
• Est. completion date: December 1, 2022

Study information

• Verified date: May 2021
• Source: Sichuan University
• Contact: Li Zheng
• Phone: +86 028-85423655
• Email: lzheng2005618[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. Know and voluntarily sign informed consent.

2. Age 18-70 years old (including 18 and 70 years old), weight =45 Kg.

3. At least one measurable lesion according to the RECIST 1.1 and RANO evaluation criteria.

4. ECOG performance status score is 0 or 1.

5. Blood chemistry test results, meet the following results:

1. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 × normal upper limit (ULN)

2. Total bilirubin = 1.5 × ULN

3. Serum albumin> 29 g / L

4. Creatinine = 1.5 × ULN or 24-hour serum creatinine clearance = 50 mL / min

5. Lipase and amylase = 2 × ULN.

6. Adequate bone marrow function and meets the following results:

1. Absolute neutrophil count (ANC) = 1.5 × 109 / L

2. Platelets = 75 × 10^9 / L

3. Hemoglobin = 90 g / L.

7. 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).

8. Life expectancy is longer than 3 months.

Exclusion Criteria:

1. Have a history of hepatic encephalopathy.

2. Have a thyroid disorder with a clinically significant thyroid dysfunction judged by the investigator (not applicable for thyroid cancer in dose expansion phase).

3. Active or history of upper gastrointestinal bleeding, ulcers, or esophageal varices with bleeding within 6 months.

4. Have a history of HIV infection and/or acquired immunodeficiency syndrome

5. Major surgery has been performed within 4 weeks before the first dose, or is expected during the study period.

6. Have a history of organ transplantation (eg., liver transplantation).

7. Poorly-controlled pleural or pericardial effusion during the screening period.

8. Other primary malignancies occurred within 5 years before the first administration of the study drug with the exception of locally curable malignancies

9. Suffering from active or previously recurring autoimmune diseases or under such a risk.

10. Systemically immunosuppressive drugs are currently used within 14 days of the first dose.

11. 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.

12. Subjects with diabetes or glycated hemoglobin (HbA1c)> 7%.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• Neoplasms

Intervention

Drug:
• ATG-008
Tablet
• Toripalimab
IV infusion

Locations

Country	Name	City	State
China	West China of Sichuan University	Chengdu	Sichuan
China	Chongqing Cancer Hospital	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Sichuan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTD	Maximum Tolerated Dose	Within 21 days after dosing
Primary	RP2D	Recommended phase 2 dose	Within 21 days after dosing
Primary	ORR	Overall Response Rate	Through study completion (approximately 2 years)
Secondary	Cmax	Peak Plasma Concentration (Cmax)	Day 1 - Day 15
Secondary	AUC	Area under the plasma concentration versus time curve (AUC)	Day 1 - Day 15
Secondary	DOR	Duration from the first observation of at least PR to time of disease progression, or deaths due to disease progression, whichever occurs first.	12 months
Secondary	DCR	Disease Control Rate (DCR=CBR+Stable Disease[SD; for a minimum of 12 weeks])	12 months
Secondary	PFS	Duration from start of study treatment to PD or death (regardless of cause), whichever comes first	12 months
Secondary	OS	The estimates of Kaplan-Meier	12 months