ATG-008 Combined With Toripalimab in Advanced Solid Tumors

S

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

  • 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).
  • Life expectancy is longer than 3 months.

Exclusion criteria

  • 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%.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Sequential Assignment

Masking

None (Open label)

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

Trial contacts and locations

0

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Central trial contact

Li Zheng

Data sourced from clinicaltrials.gov

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