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SIM0613 in Participants With Advanced Solid Tumors

NCT07618260 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 294

Last updated 2026-06-01

No results posted yet for this study

Summary

This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, efficacy and pharmacokinetic/pharmacodynamic characteristics of SIM0613 in participants with locally advanced/ metastatic solid tumors. The study starts with a dose escalation part (Part 1) followed by a dose expansion part (Part 2).

Conditions

  • Advanced Solid Cancer

Interventions

DRUG

SIM0613

Administered as an intravenous infusion in dosing cycles

DRUG

SIM0613

Administered as an intravenous infusion in dosing cycles

Sponsors & Collaborators

  • Shanghai Xianwei Medical Technology Co., Ltd.

    collaborator UNKNOWN

  • Jiangsu Simcere Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-15
Primary Completion
2028-06-30
Completion
2028-12-31

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 NCT07618260 on ClinicalTrials.gov