A Phase I/II, First-in-Human Study to Evaluate TJ102 in Participants With Advanced or Metastatic Ovarian Cancer and Other Solid Tumors.

Sponsor
Phrontline Biopharma
Study ID
NCT07778498
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • TJ102 — BIOLOGICAL
    TJ102 is a CDH6/FRa directed antibody conjugate with dual payloads

Study Details

The goal of this clinical trial is to evaluate whether TJ102, an investigational antibody-drug conjugate (ADC), can safely and effectively treat patients with advanced ovarian or other solid tumors. The main objectives of this study are : • To Determine the maximum tolerated dose (MTD) and recommended dose for expansion (RDE) of TJ102 • to show preliminary antitumor activity in patients with advanced ovarian or other solid tumors. Participants will: • Receive intravenous (IV) infusions of TJ102 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 ovarian or other solid tumors who have exhausted standard treatment options.

Key Dates

First listed
Aug 21, 2026
Start date
Sep 15, 2026
Status verified
Aug 2026
Primary completion
Sep 30, 2029
Completion
Sep 30, 2030

Study Design

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

Arms

  • Experimental: TJ102
    TJ102 will be infused intravenously once every 3 weeks. Participants will receive TJ102 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: 2 years ]

Central Contacts

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