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First in Human Study of SIM0610 in Solid Tumors

NCT07348211 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2026-01-23

No results posted yet for this study

Summary

This is a multicenter, open-label, first-in-human (FIH) study to evaluate the safety, tolerability, pharmacokinetic/pharmacodynamic profile, and preliminary antitumor activity of SIM0610 in subjects with locally advanced/metastatic solid tumors. Accelerated titration (ATD) and Bayesian optimal interval design (BOIN) will be used to guide dose escalation in part1, the preliminary anti-tumor effect of SIM0610 will to be further evaluated in part 2.

Conditions

Interventions

DRUG

SIM0610 for Injection

intravenous infusion

DRUG

SIM0610 for Injection

intravenous infusion

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
2026-01-19
Primary Completion
2027-12-31
Completion
2029-07-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT07348211 on ClinicalTrials.gov