A Phase I/II, First-in-Human Study to Evaluate TJ102 in Participants With Advanced or Metastatic Ovarian Cancer and Other Solid Tumors.
NCT07778498 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2026-08-21
Summary
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.
Conditions
Interventions
- BIOLOGICAL
-
TJ102
TJ102 is a CDH6/FRa directed antibody conjugate with dual payloads
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
- 2026-09-15
- Primary Completion
- 2029-09-30
- Completion
- 2030-09-30
- FDA Drug
- Yes
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