Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06686745

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fudan University Shanghai Cancer Center, Shanghai, Shanghai Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Voluntary participation and signature of informed consent form.
  • Participants with histologically confirmed ovarian cancer, prostate cancer,breast cancer , or pancreatic cancer.
  • ECOG score of 0 or 1.
  • Expected survival ≥ 12 weeks.

Exclusion criteria

  • Active hepatitis B (HBsAg or HBcAb positive and HBV DNA≥1×104 copies/mL or≥2000 international unit [IU]/mL) or hepatitis C (HCV antibody positive and HCV RNA≥ULN) infection; participant with HBsAg positive or detective HBV-DNA at screening should receive antiviral treatment as per local practice during the study.
  • Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
  • Participants unable to swallow study drug and participants with gastrointestinal disorders likely to interfere with absorption of the study drug.
  • Toxicities from previous anticancer therapies have not resolved (e.g to ≤ Grade 1).
  • Pregnant or nursing (lactating) women; other women of childbearing potential, unless the blood pregnancy test within 7 days of first dose of study drug is negative, and participants agree to use highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of SIM0508 or olaparib, whichever comes later.
  • Male partinipants with female partners of reproductive potential, unless they agree to use highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of SIM0508 and 90 days after the last dose of olaparib, whichever comes later.

Treatment and study plan

SIM0508 Tablets

Drug

Every 28 days is one cycle. Multiple dose levels of SIM0508 will be explored in dose escalation, and determine the maximum tolerated dose.

SIM0508 in combination with olaparib

Drug

Every 28 days is one cycle.Multiple dose levels of SIM0508 and olaparib will be explored in dose escalation, and determine the maximum tolerated dose.

Primary outcomes

  1. Dose-limiting toxicity (DLT)

    Time frame: At the end of Cycle 1 (each cycle is 28 days)

    Primary Endpoints

Study contacts

Contact information is provided by the study sponsor or research team.

Juan Wen Wang

CONTACT

[email protected]

65212241 ext. 010

Sponsors and collaborators

Lead sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Industry

Collaborators

  • Shanghai Xianxiang Medical Technology Co., Ltd.

Registry information

Official study title

A Phase I, First-in-Human, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0508 Monotherapy and Combination Therapy in Adult Participants With Locally Advanced/Metastatic Solid Tumors

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Nov 13, 2024
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.