Spots Global Cancer Trial Database for A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG 037 Monotherapy and Combination Therapy With Pembrolizumab in Patients With Advanced Solid Tumors
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Trial Identification
Brief Title: A Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG 037 Monotherapy and Combination Therapy With Pembrolizumab in Patients With Advanced Solid Tumors
Official Title: A Phase I/Ib, Multi-center, Open-label, and Dose-finding Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG-037 Monotherapy and Combination Therapy With Pembrolizumab in Patients With Locally Advanced or Metastatic Solid Tumors
Study ID: NCT05205109
Study Description
Brief Summary: This is a study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors
Detailed Description: This is a Phase I, Multi-center, Open-label, and Dose-finding Study to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors. Number of subjects : 1. 39-51 subjects for Dose escalation phase part 1 2. Maximum of 18 subjects or Dose escalation phase part 2 3. 24-34 subjects per Dose expansion cohort
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Calvary Mater Newcastle, Sydney, New South Wales, Australia
Pindara Private Hospital, Benowa, Queensland, Australia
Southern Oncology Clinical Research Unit, Bedford Park, South Australia, Australia
Peninsula & South Eastern Haematology and Oncology Group, Frankston, Victoria, Australia
One Clinical Research Pty Ltd, Mount Pleasant, Western Australia, Australia
Chongqing Cancer Hospital, Chongqing, Chongqing, China
Guangdong Provincial People's Hospital, Guangzhou, Guangdong, China
Contact Details
Name: Ganessan Kichenadasse, MD
Affiliation: Southern Oncology Clinical Research Unit
Role: PRINCIPAL_INVESTIGATOR
Name: Yi-Long Wu, PhD
Affiliation: Guangdong Provincial People's Hospital
Role: PRINCIPAL_INVESTIGATOR
Name: Qing Zhou
Affiliation: Guangdong Provincial People's Hospital
Role: PRINCIPAL_INVESTIGATOR
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