A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of TJ101 in Patients With Advanced/Metastatic Solid Tumors

The goal of this clinical trial is to evaluate whether TJ101, an investigational antibody-drug conjugate (ADC), can safely and effectively treat patients with advanced solid tumors. The main objectives of this study are : * To Determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) of TJ101 * to show preliminary antitumor activity in patients with advanced solid tumors Participants will: * Receive intravenous (IV) infusions of TJ101 at escalating dose levels (during dose escalation) or at the selected expansion dose. * Undergo regular tumor imaging to assess res

Trial Details

NCT ID
NCT07181473
Phase
PHASE1
Sponsor
Phrontline Biopharma
Status
RECRUITING
Cancer Type
Lung Cancer
Interventions
  • TJ101
Locations (sample)
  • Orlando, Florida, United States|28.53834,-81.37924
  • Nashville, Tennessee, United States|36.16589,-86.78444
  • Houston, Texas, United States|29.76328,-95.36327
  • Zhengzhou, Henan, China|34.75778,113.64861
  • Wuhan, Hubei, China|30.58333,114.26667

Key Eligibility Criteria

  • Histological and/or cytological diagnosis of advanced/metastatic solid tumors, who have failed standard treatment, or have no standard therapy.
  • Have at least one measurable lesion by RECIST v1.1 (Eisenhauer et al., 2009) for solid tumors.
  • Men or women ≥18 years old.
  • Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) of 0 to 1.

For full eligibility, visit ClinicalTrials.gov.

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