Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT04998422

A Study of HG381 Administered to Patients With Advanced Solid Tumors

Led by HitGen Inc. · Updated on 2025-03-13

57

Participants Needed

1

Research Sites

215 weeks

Total Duration

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AI-Summary

What this Trial Is About

This is a Phase I, first in human, open-label, non-randomized, multicenter study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, preliminary efficacy and establish a recommended dose of HG381 administered intravenously (IV) alone in subjects with advanced solid tumors.

CONDITIONS

Official Title

A Study of HG381 Administered to Patients With Advanced Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide signed informed consent
  • Life expectancy of at least 3 months
  • Histological or cytological confirmation of advanced or recurrent solid tumor
  • Disease measurable by RECIST version 1.1 with at least one measurable lesion
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Adequate organ function including blood counts, liver, kidney, heart, and thyroid function within specified limits
  • Fertile subjects must agree to use effective contraception during the study and for at least 3 months after last dose
Not Eligible

You will not qualify if you...

  • Received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy, or other anticancer treatment within 4 weeks
  • Use of systemic immunosuppressive treatment within 4 weeks before first dose
  • Received any live vaccine within 4 weeks of study treatment start
  • Participation in unmarketed clinical trial drugs or treatments within 4 weeks
  • Surgery or interventional treatments (excluding biopsy) within 4 weeks
  • History or evidence of cardiovascular or cerebrovascular disease risk
  • Uncontrolled diabetes
  • Symptomatic CNS metastases or asymptomatic CNS metastases requiring steroids within 2 weeks
  • Current or past malignant tumors (other than target disease)
  • Uncontrollable pleural, pericardial effusion, or ascites needing frequent drainage
  • Active or suspected autoimmune disease
  • History of pulmonary fibrosis, interstitial lung disease, organizing pneumonia, or active pneumonitis
  • Severe toxicity from previous immunotherapy leading to discontinuation or unresolved toxicity higher than Grade 1
  • Acute bacterial, viral, or fungal infections needing systemic treatment
  • Positive for syphilis or HIV antibodies
  • Allergy to test drug or its ingredients
  • Pregnant or breastfeeding women
  • Known drug or alcohol abuse
  • Mental or neurological diseases
  • Prior bone marrow or solid organ transplantation
  • Serious systemic diseases or any condition deemed unsuitable by investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

HitGen Inc.

Chengdu, Sichuan, China, 610200

Actively Recruiting

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Research Team

J

Jie Shen, M.S

CONTACT

C

Can Xu, B.S

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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