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

NCT07265921 | Recruiting Phase 1 FDA Drug

• 1 other identifier: SIM0609-101
• Study Type: interventional
• Target: 232
• Locations: 1 country
• Sites: 6

Brief 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

Outcome Measures

Primary Outcomes (3)

• Dose escalation:Dose -limiting toxicity (DLT)

  At the end of Cycle 1 (each cycle is 21/28days)

• Dose escalation:Safety and Tolerability

  Safety and tolerability: Incidence and severity of AEs and serious adverse events (SAEs) assessed by CTCAE v5.0, changes in laboratory values, vital signs, and ECGs. AE related dose interruptions, dose reduction and treatment discontinuation, dose intensity

  2 years

• Dose escalation: Objective response rate(ORR)

  Proportion of subjects who have a complete or partial response assessed by investigator per RECIST 1.1

  2 years

Study Arms (5)

A dose escalation of SIM0609

EXPERIMENTAL

Multiple dose levels of SIM0609 will be explored in dose escalation, and determine the maximum tolerated dose.

Drug: SIM0609 for injection

A dose expansion of SIM0609 -CRC cohort

EXPERIMENTAL

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: dose expansion of SIM0609 in CRC

A dose expansion of SIM0609-GC/GEJC cohort

EXPERIMENTAL

1\~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in gastric/gastroesophageal junction adenocarcinoma (GC/GEJC)

Drug: dose expansion of SIM0609 in GC/GEJC cohort

A dose expansion of SIM0609-PDAC cohort

EXPERIMENTAL

1\~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in pancreatic ductal adenocarcinoma (PDAC)

Drug: dose expansion of SIM0609 in PDAC cohort

A dose expansion of SIM0609-positive other solid tumors cohort

EXPERIMENTAL

1\~3 dose levels of SIM0609 will be explored in dose expansion to evaluate the preliminary anti-tumor activity of SIM0609 in positive other solid tumors

Drug: dose expansion of SIM0609 in positive other solid tumors

Interventions

SIM0609 for injection DRUG

Multiple dose levels of SIM0609 will be explored in dose escalation

A dose escalation of SIM0609

dose expansion of SIM0609 in CRC DRUG

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)

A dose expansion of SIM0609 -CRC cohort

dose expansion of SIM0609 in GC/GEJC cohort DRUG

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

A dose expansion of SIM0609-GC/GEJC cohort

dose expansion of SIM0609 in PDAC cohort DRUG

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

A dose expansion of SIM0609-PDAC cohort

dose expansion of SIM0609 in positive other solid tumors DRUG

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

A dose expansion of SIM0609-positive other solid tumors cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation and signature of informed consent form;
• At least 18 years old, male or female;
• Participants with histologically and/or cytologically confirmed locally advanced/metastatic solid tumors;
• Participants should have at least one evaluable or measurable tumor lesion;
• Participants have failed the standard of therapy in the locally advanced/metastatic setting;
• Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1;
• Expected survival ≥12 weeks;
• Adequate organ and bone marrow function;
• Availability of archival formalin-fixed, paraffin-embedded (FFPE) tumor tissue, or fresh biopsies within 28 days before first administration, is mandatory

You may not qualify if:

• Active second primary malignancies within the previous 2 years except for localized cancers that are considered to have been cured and in the opinion of the Investigator present a low risk for recurrence;
• Symptomatic central nervous system (CNS) metastases or CNS metastases requiring CNS-directed local therapy or corticosteroid treatment that occurred within 2 weeks prior to the first administration of the investigational treatment;
• Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging screening;
• Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study ;
• Any active infections requiring systemic therapy within 2 weeks prior to the initiation of the study treatment;
• Uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage or medical intervention within 4 weeks before the first dose of study treatment;
• Not recovered from previous anticancer therapy-induced AEs(Adverse Events);
• Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of study treatment;
• Received prior therapies within the following time frames prior to the first dose of study treatment:
• Previous cytotoxic therapy, anticancer targeted small molecules within 2 weeks.
• Anti-cancer antibody, immune checkpoint inhibitor or ADC within 5 half-lives or 4 weeks (whichever is shorter).
• Chinese medicines/herbal preparations with anticancer indication taken within 2 weeks.
• Radiation therapy within 4 weeks.
• Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody drug conjugate (ADC) therapies or CDH17-targeted ADC therapies.
• Use of any live vaccine therapy within 4 weeks prior to the first dose of study treatment.

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead
• Shanghai Xianwei Medical Technology Co., Ltd.: collaborator

Study Sites (6)

Beijing Cancer Hospital

Beijing, China

RECRUITING

Jiangsu Province Hospital

Nanjing, China

NOT YET RECRUITING

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

NOT YET RECRUITING

Zhongshan Hospital，Fudan University

Shanghai, China

NOT YET RECRUITING

Tianjin Cancer Hospital

Tianjin, China

NOT YET RECRUITING

Hubei Cancer Hospital

Wuhan, China

NOT YET RECRUITING

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Jinxiu Zhang

CONTACT

86-010-65212241; zhangjinxiu@zaiming.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Sequential Assignment

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 5, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: December 5, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)