First in Human Study of SIM0610 in Solid Tumors

Sponsor
Jiangsu Simcere Pharmaceutical Co., Ltd.
Study ID
NCT07348211
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SIM0610 for Injection — DRUG
    intravenous infusion
  • SIM0610 for Injection — DRUG
    intravenous infusion

Study Details

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.

Key Dates

First listed
Jan 16, 2026
Start date
Jan 19, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2027
Completion
Jul 31, 2029

Study Design

Enrollment
260 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose escalation
    SIM0610 administered intravenously at selected dose levels according to protocol
  • Experimental: Cohort expansion
    SIM0610 administered intravenously at Recommended dosage(RDs) according to protocol

Primary Outcome Measure

Dose Limiting Toxicity (DLT) [ Time Frame: From time of first dose of SIM0610 to end of DLT period (approximately 21 days) ]

Central Contacts

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