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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

NCT05205109 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2025-06-09

No results posted yet for this study

Summary

This is a study of ATG-037 Monotherapy and Combination Therapy with Pembrolizumab in Patients with Locally Advanced or Metastatic Solid Tumors

Conditions

  • Locally Advanced or Metastatic Solid Tumors

Interventions

DRUG

ATG-037

Part I : ATG-037 will be administered orally once a day (QD) on D-2, then multiple doses of ATG-037 will be administered orally BID for every day from C1D1. A treatment cycle will be defined as 21 days. Part II: ATG-037 will be administered orally BID for every day from C1D1.

DRUG

KEYTRUDA ®( Pembrolizumab)

Part I: After 2 cycles of ATG-037 monotherapy, eligible participants will receive ATG-037 combination therapy with Keytruda ®(Pembrolizumab) 200mg/Q3W fixed dose for up to 35 administrations (approximately 2 years). Part II: Keytruda ®(Pembrolizumab) will be administered from C1.

Sponsors & Collaborators

Principal Investigators

  • Ganessan Kichenadasse, MD · Southern Oncology Clinical Research Unit

  • Yi-Long Wu, PhD · Guangdong Provincial People's Hospital

  • Qing Zhou · Guangdong Provincial People's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-07
Primary Completion
2027-08-30
Completion
2028-02-28

Countries

  • Australia
  • China

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05205109 on ClinicalTrials.gov