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

NCT07181473 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-01-12

No results posted yet for this study

Summary

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

Conditions

  • Lung Cancer (NSCLC)
  • Prostate Cancer
  • Esophageal Cancer
  • Solid Tumor Malignancies

Interventions

DRUG

TJ101

TJ101 is a EGFR/B7H3 directed antibody conjugate with a cleavable linker and a noval topoisomerase I inhibitor.

Sponsors & Collaborators

  • Phrontline Biopharma

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-25
Primary Completion
2026-12-30
Completion
2027-09-15
FDA Drug
Yes

Countries

  • United States
  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07181473 on ClinicalTrials.gov