Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06686745

Study of SIM0508 Alone and in Combination in Patients With Advanced Solid Tumors

Led by Jiangsu Simcere Pharmaceutical Co., Ltd. · Updated on 2025-01-07

130

Participants Needed

2

Research Sites

212 weeks

Total Duration

On this page

Sponsors

J

Jiangsu Simcere Pharmaceutical Co., Ltd.

Lead Sponsor

S

Shanghai Xianxiang Medical Technology Co., Ltd.

Collaborating Sponsor

AI-Summary

What this Trial Is About

This is a multicenter, open-label, first-in-human study to evaluate the safety,efficacy, and PK/PD characteristics of SIM0508 as a single agent and in combination with olaparib in participants with locally advanced/metastatic solid tumors.

CONDITIONS

Official Title

Study of SIM0508 Alone and in Combination in Patients With Advanced Solid Tumors

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Voluntary participation with signed informed consent
  • Adults with confirmed ovarian, prostate, breast, or pancreatic cancer
  • ECOG performance status of 0 or 1
  • Expected survival of 12 weeks or more
Not Eligible

You will not qualify if you...

  • Active hepatitis B or C infection
  • Known HIV infection or AIDS
  • Unable to swallow study medication or have gastrointestinal conditions affecting drug absorption
  • Unresolved toxicities from previous cancer treatments above Grade 1
  • Pregnant, nursing, or women of childbearing potential without a recent negative pregnancy test and contraceptive agreement
  • Male participants with female partners of reproductive potential who do not agree to use highly effective contraception

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Actively Recruiting

2

Chongqing Cancer Hospital

Chongqing, China

Actively Recruiting

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Research Team

J

Juan Wen Wang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

3

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