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A Phase I Study of SIM0609 in Adult Participants With Locally Advanced/Metastatic Solid Tumors

NCT07265921 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 232

Last updated 2025-12-05

No results posted yet for this study

Summary

This is an open-label,multicenter phase I study to evaluate the safety,Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants with Locally Advanced/Metastatic Solid Tumors

Conditions

  • Advanced Solid Cancer

Interventions

DRUG

dose expansion of SIM0609 in GC/GEJC cohort

1\~3 dose levels of SIM0609 will be explored in dose expansion in GC/GEJC cohort

DRUG

dose expansion of SIM0609 in PDAC cohort

1\~3 dose levels of SIM0609 will be explored in dose expansion in PDAC cohort

DRUG

dose expansion of SIM0609 in positive other solid tumors

1\~3 dose levels of SIM0609 will be explored in positive other solid tumors cohort

DRUG

dose expansion of SIM0609 in CRC

1\~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in colorectal carcinoma (CRC)

DRUG

SIM0609 for injection

Multiple dose levels of SIM0609 will be explored in dose escalation

Sponsors & Collaborators

  • Shanghai Xianwei Medical Technology Co., Ltd.

    collaborator UNKNOWN

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-07
Primary Completion
2028-12-31
Completion
2029-06-30
FDA Drug
Yes

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07265921 on ClinicalTrials.gov