Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06314373

A Study for HSK39775 in Participants With Solid Tumors

Led by Xizang Haisco Pharmaceutical Co., Ltd · Updated on 2024-03-18

243

Participants Needed

1

Research Sites

234 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research is designed to determine if HSK39775 is safe, tolerable, and has anti-cancer activity in patients with advanced solid tumors.

CONDITIONS

Official Title

A Study for HSK39775 in Participants With Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older at screening
  • Histological or cytological confirmation of advanced malignancy with failed or intolerant standard treatment, no standard therapy recognized, or standard therapy unavailable
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Presence of evaluable disease
  • Life expectancy of at least 12 weeks
  • Adequate organ and bone marrow function as defined by protocol
  • Female patients of childbearing potential must have a negative pregnancy test within 7 days before first dose and agree to use effective contraception during treatment and for 6 months after last dose
  • Male patients must agree to use effective contraception during treatment and for 6 months after last dose
  • Written informed consent obtained
Not Eligible

You will not qualify if you...

  • Known allergies to HSK39775 or its excipients
  • Ineligible prior anticancer treatment as per protocol
  • Use of continuous corticosteroids above 10 mg prednisone/day or equivalent within 4 weeks before first dose
  • Receipt of live vaccine within 4 weeks before first dose
  • Current participation in another investigational study
  • Prior treatment with agents targeting the same pathway
  • Unresolved toxicities from previous therapies above grade 1 or baseline
  • Use of drugs with potential interactions within 4 weeks or 5 half-lives before first dose
  • Major surgery within 4 weeks before first dose
  • Central nervous system metastases with neurological symptoms
  • Active hepatitis B or C infection
  • History of immunodeficiency
  • Clinically relevant cardiovascular disease as defined by protocol
  • Inability to swallow study drug or gastrointestinal conditions affecting absorption
  • Pregnancy or lactation
  • Other conditions 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

Fundan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China, 200032

Actively Recruiting

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Research Team

Y

Yong Cao

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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