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

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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 — DRUG
    Dose 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

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