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

Part of paid clinical trials in Orlando, Florida.

Sponsor
Phrontline Biopharma
Study ID
NCT07181473
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Aug 25, 2025
Status verified
Sep 2025
Primary completion
Dec 30, 2026
Completion
Sep 15, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: TJ101
    TJ101 will be infused intravenously once every 3 weeks. Participants will receive TJ101 at escalating dose levels (during dose escalation) or at the selected expansion dose.

Primary Outcome Measure

Number of participants with Dose-limiting toxicities [ Time Frame: 21 Days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Florida Cancer Specialists & Research InstituteOrlandoFlorida32827
Elizabeth Gilmore
904-380-2410
Sarah Cannon Research Institute (SCRI)NashvilleTennessee37203
Misty Moore
615-524-4025
Oncology ConsultantsHoustonTexas77030
Julio Peguero, Md
[email protected]
855-827-9525

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