Phrontline Biopharma
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 response. * Provide blood samples for pharmacokinetics (PK) and biomarker analysis. * Be monitored for side effects and overall tolerability. This study is being conducted in adult patients with advanced or metastatic solid tumors who have exhausted standard treatment options
This is a first-in-human, Phase I, open-label, multicenter study designed to evaluate the safety, tolerability, pharmacokinetics (PK), immunogenicity, and preliminary efficacy of TJ101, a bispecific antibody-drug conjugate (ADC) targeting EGFR and B7-H3, in patients with advanced or metastatic solid tumors. Study Objectives Phase Ia (Dose Escalation) * Primary: Assess safety/tolerability; determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and recommended dose(s) for expansion (RDEs). * Secondary: Characterize PK profile, assess preliminary anti-tumor activity, and evalu…
Inclusion Criteria: 1. Histological and/or cytological diagnosis of advanced/metastatic solid tumors, who have failed standard treatment, or have no standard therapy. 2. Have at least one measurable lesion by RECIST v1.1 (Eisenhauer et al., 2009) for solid tumors. 3. Men or women ≥18 years old. 4. Eastern Cooperative Oncology Group (ECOG) performance status (Oken et al., 1982) of 0 to 1. 5. Life expectancy of ≥ 12 weeks; 6. Patients with adequate organ function and the laboratory test criteria specifically defined as follows within 7 days prior to the first dosing. * Hepatic function: AST…
TJ101 is a EGFR/B7H3 directed antibody conjugate with a cleavable linker and a noval topoisomerase I inhibitor.