ATG-008 Combined With Toripalimab in Advanced Solid Tumors

NCT04337463 | Unknown Phase 1

• 1 other identifier: ATG-008-HX-001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Advanced Solid Tumor

Outcome Measures

Primary Outcomes (3)

• MTD

  Maximum Tolerated Dose

  Within 21 days after dosing

• RP2D

  Recommended phase 2 dose

  Within 21 days after dosing

• ORR

  Overall Response Rate

  Through study completion (approximately 2 years)

Secondary Outcomes (6)

• Cmax

  Day 1 - Day 15

• AUC

  Day 1 - Day 15

• DOR

  12 months

• DCR

  12 months

• PFS

  12 months

Study Arms (1)

ATG-008 and Toripalimab

EXPERIMENTAL

Toripalimab will be combined with ATG-008.

Drug: ATG-008; Drug: Toripalimab

Interventions

ATG-008 DRUG

Tablet

ATG-008 and Toripalimab

Toripalimab DRUG

IV infusion

ATG-008 and Toripalimab

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Know and voluntarily sign informed consent.
• Age 18-70 years old (including 18 and 70 years old), weight ≥45 Kg.
• At least one measurable lesion according to the RECIST 1.1 and RANO evaluation criteria.
• ECOG performance status score is 0 or 1.
• Blood chemistry test results, meet the following results:
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × normal upper limit (ULN)
• Total bilirubin ≤ 1.5 × ULN
• Serum albumin\> 29 g / L
• Creatinine ≤ 1.5 × ULN or 24-hour serum creatinine clearance ≥ 50 mL / min
• Lipase and amylase ≤ 2 × ULN.
• Adequate bone marrow function and meets the following results:
• Absolute neutrophil count (ANC) ≥ 1.5 × 109 / L
• Platelets ≥ 75 × 10\^9 / L
• Hemoglobin ≥ 90 g / L.
• 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).

You may not qualify if:

• Have a history of hepatic encephalopathy.
• Have a thyroid disorder with a clinically significant thyroid dysfunction judged by the investigator (not applicable for thyroid cancer in dose expansion phase).
• Active or history of upper gastrointestinal bleeding, ulcers, or esophageal varices with bleeding within 6 months.
• Have a history of HIV infection and/or acquired immunodeficiency syndrome
• Major surgery has been performed within 4 weeks before the first dose, or is expected during the study period.
• Have a history of organ transplantation (eg., liver transplantation).
• Poorly-controlled pleural or pericardial effusion during the screening period.
• Other primary malignancies occurred within 5 years before the first administration of the study drug with the exception of locally curable malignancies
• Suffering from active or previously recurring autoimmune diseases or under such a risk.
• Systemically immunosuppressive drugs are currently used within 14 days of the first dose.
• 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.
• Subjects with diabetes or glycated hemoglobin (HbA1c)\> 7%.

Sponsors & Collaborators

• Sichuan University: lead

Study Sites (2)

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

RECRUITING

West China of Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

MeSH Terms

Interventions

toripalimab

Study Officials

• Li Zheng

  West China Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Zheng

CONTACT

+86 028-85423655; lzheng2005618@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2020
• First Posted: April 7, 2020
• Study Start: April 23, 2020
• Primary Completion: May 1, 2022
• Study Completion: December 1, 2022
• Last Updated: May 17, 2021

Record last verified: 2021-05

Locations

CN (2)