Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06927570

A Study of HS-20122 in Patients With Advanced Solid Tumors

Led by Hansoh BioMedical R&D Company · Updated on 2026-01-16

1050

Participants Needed

1

Research Sites

167 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a first-in-human (FIH) Phase I, multi-center, open-label, study of HS-20122, in patients with advanced solid tumors. This study will evaluate the safety, tolerability, pharmacokinetics and efficacy of HS-20122 in advanced solid tumors.

CONDITIONS

Official Title

A Study of HS-20122 in Patients With Advanced Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 18 years or older
  • Histologically or cytologically confirmed locally advanced or metastatic solid tumors
  • Standard treatment is invalid, unavailable, or intolerable
  • At least one target lesion measurable by RECIST 1.1 criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Estimated life expectancy greater than 12 weeks
  • Use of adequate contraceptive measures throughout the study for men and women
  • Women must have evidence of non-childbearing potential
  • Signed and dated informed consent form
Not Eligible

You will not qualify if you...

  • Unresolved toxicities from prior therapy greater than Grade 2 by CTCAE 5.0, except alopecia or neurotoxicity
  • History of other primary cancers
  • Inadequate bone marrow or organ function
  • Evidence of cardiovascular risk
  • Severe or poorly controlled diabetes
  • Severe or poorly controlled hypertension
  • Clinically significant bleeding or bleeding tendency within 1 month prior to first dose
  • Severe arteriovenous thrombotic events within 3 months
  • Severe infection within 4 weeks prior to first dose
  • Steroid therapy longer than 30 days
  • Known active infections
  • Significant gastrointestinal dysfunction
  • Hepatic encephalopathy, hepatorenal syndrome, or liver cirrhosis Child-Pugh Grade B or worse
  • Moderate to severe pulmonary diseases
  • Significant neurological or mental disorders
  • Women who are pregnant, breastfeeding, or planning pregnancy during the study
  • Hypersensitivity to any ingredient of HS-20122
  • Unlikely to comply with study procedures or restrictions as judged by investigator
  • Any disease or condition that may compromise safety or interfere with study assessments

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

Ethics Committee of Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Actively Recruiting

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Research Team

K

Ketao Chen

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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