ATG-008 Combined With Toripalimab in Advanced Solid Tumors

Sichuan University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Advanced Solid Tumor

Treatments: Drug: ATG-008; Drug: Toripalimab

Study type: Interventional

Funder types: Other

Identifiers

NCT04337463

ATG-008-HX-001

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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%.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Sequential Assignment

Masking: None (Open label)

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60 participants in 1 patient group

ATG-008 and Toripalimab

Experimental group

Description:

Toripalimab will be combined with ATG-008.

Treatment:

Drug: Toripalimab

Drug: ATG-008