A Phase I Study to Evaluate the Safety,Pharmacokinetics,Pharmacodynamics,and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors
- Sponsor
- TJ Biopharma Co., Ltd.
- Study ID
- NCT07715747
- Phase
- PHASE1
- Status
- Not Yet Recruiting
Notify me when recruiting opens
Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.
Add your contact details and location so we can keep your interest tied to this study.
Conditions
- Metastatic Endometrial Carcinoma
- Metastatic Gastric Cancer
- Metastatic Ovary Cancer
- Solid Tumor
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- TJ037130 — DRUGDose Escalation:TJ037130 will be administered at up to 5 dose levels(0.75,2,5,10 and 18mg/kg) once 3 weeks(Q3W); During dose expansion, TJ037130 will be administered once 3 weeks in 4 Cohorts.
Study Details
The goal of this clinical trial is to evaluate the safety and tolerability of TJ037130 in participants with advanced or metastatic solid tumors, and to determine the Potential Optimal Biological Dose (POBD) of TJ037130 for subsequent investigations.
Key Dates
- First listed
- Jul 20, 2026
- Start date
- Aug 21, 2026
- Status verified
- Jul 2026
- Primary completion
- Jun 30, 2028
- Completion
- Jun 30, 2028
Study Design
- Enrollment
- 128 participants (estimated)
- Allocation
- NA
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: TJ037130
Primary Outcome Measure
Incidence,type,severity and correlation with study treament of AEs [ Time Frame: Up to 90 days post last dose ]
Central Contacts
- Lina Qin+86-18600672907
- Liting Liu+86-15026781022
Related Studies
- A Study of Pembrolizumab (MK-3475) in Pediatric Participants With an Advanced Solid Tumor or Lymphoma (MK-3475-051/KEYNOTE-051)PHASE1/PHASE2 · Recruiting · Merck Sharp & Dohme LLC · Aurora, Colorado
- Metronomic Therapy for Pediatric Patients With Solid Tumors at High Risk of RecurrenceEARLY_PHASE1 · Recruiting · Miller Children's & Women's Hospital Long Beach · Long Beach, California
- Umbilical Cord Blood Transplantation From Unrelated DonorsRecruiting · University of Rochester · Rochester, New York
- Dabrafenib and/or Trametinib Rollover StudyPHASE4 · Recruiting · Novartis Pharmaceuticals · Scottsdale, Arizona