First in Human Study of SIM0610 in Solid Tumors

NCT07348211 | Recruiting Phase 1

• 1 other identifier: SIM0610-101
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 7

Brief 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

Advanced Solid Tumours; Non-Small Cell Lung Cancer; Colorectal Cancer; Head and Neck Squamous Cell Carcinoma; Hepatocellular Carcinoma

Keywords

Locally Advanced/Metastatic Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Dose Limiting Toxicity (DLT)

  From time of first dose of SIM0610 to end of DLT period (approximately 21 days)

• Safety and Tolerability

  From time of Informed Consent to 28 days post last dose of SIM0610

• Objective response rate (ORR)

  Objective response rate (ORR) assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  From date of first dose of SIM0610 up until progression, or the last evaluable assessment in the absence of progression (approximately 2 years)

Study Arms (2)

Dose escalation

EXPERIMENTAL

SIM0610 administered intravenously at selected dose levels according to protocol

Drug: SIM0610 for Injection

Cohort expansion

EXPERIMENTAL

SIM0610 administered intravenously at Recommended dosage(RDs) according to protocol

Drug: SIM0610 for Injection

Interventions

SIM0610 for Injection DRUG

intravenous infusion

Cohort expansion

Eligibility Criteria

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

You may qualify if:

• Voluntarily participate and sign the informed consent form
• At least 18 years old, male or female
• Subjects with locally advanced/metastatic solid tumors confirmed by histology and/or cytology;
• Subjects in Part 1 should have at least one tumor lesion evaluable by RECIST v1.1 criteria, and subjects in Part 2 should have at least one measurable tumor lesion by RECIST v1.1 (lesions that have received radiotherapy or other local treatments cannot be used as target lesions unless there is clear progression of the lesion)
• Subjects with locally advanced/metastatic solid tumors who have failed standard treatment: Part 1: Subjects with solid tumors who have experienced disease progression during/after at least one previous standard systemic anti-tumor regimen and are not suitable for standard treatment. Part 2: Non-small cell lung cancer, liver cancer, head and neck squamous cell carcinoma, colorectal cancer that have experienced disease progression during/after at least one previous standard systemic anti-tumor regimen and are not suitable for standard treatment
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Expected survival period ≥ 12 weeks
• Adequate organ and bone marrow function
• Archived formalin-fixed, paraffin-embedded (FFPE) tumor tissue or fresh biopsy tissue within 5 years must be provided before the first administration

You may not qualify if:

• A history of active second primary malignancy within the past 2 years, except for localized tumors that are considered cured and have a low risk of recurrence as assessed by the investigator.
• Symptomatic central nervous system (CNS) metastases occurring within 2 weeks prior to the first dose of study treatment; or requirement for local therapy (e.g., radiotherapy or surgery) for CNS metastases; or requirement for corticosteroid therapy for CNS metastases.
• A history of non-infectious interstitial lung disease (ILD)/pulmonary inflammation requiring corticosteroid treatment; current ILD/pulmonary inflammation; or suspected ILD/pulmonary inflammation that cannot be ruled out by screening imaging.
• Uncontrolled pleural effusion, pericardial effusion, or ascites, or occurrence of such effusions requiring drainage or medical intervention within 4 weeks prior to the first dose of study treatment.
• Failure to recover from adverse events (AEs) induced by prior anti-tumor therapy (i.e., recovery to Grade 1 or baseline level).
• Current participation in a study involving investigational drugs or medical devices, or participation in such a study within 4 weeks prior to the first dose of study treatment.
• Receipt of the following therapies prior to the first dose of study treatment:
• Cytotoxic therapy within 3 weeks; or anti-tumor targeted small-molecule drugs (e.g., tyrosine kinase inhibitors) within 2 weeks.
• Anti-tumor antibody-based immune checkpoint inhibitors, antibody-drug conjugates (ADCs), or other anti-tumor biologics within the shorter of 5 half-lives or 4 weeks.
• Traditional Chinese medicines (TCMs)/herbal preparations with anti-tumor indications within 2 weeks.
• Radiotherapy within 4 weeks.
• Received antibody-drug conjugate (ADC) with topoisomerase I inhibitor (TOP1i) or other ADC targeting EGFR/cMET.
• Received any live vaccine within 4 weeks prior to the first dose of study treatment.
• Received the following medications ≤ 14 days prior to the first dose of study treatment:
• Strong or moderate CYP3A4 induction/inhibitor;

Sponsors & Collaborators

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

Study Sites (7)

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, 400000, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

NOT YET RECRUITING

the First Hospital of China Medical University

Shenyang, Liaoning, 110000, China

NOT YET RECRUITING

The Affiliated Cancer Hospital of Shandong First Medical University& Shan Dong Cancer Hospital

Jinan, Shandong, 250117, China

RECRUITING

Shanghai East Hospital

Shanghai, Shanghai Municipality, 200000, China

NOT YET RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200000, China

NOT YET RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200000, China

NOT YET RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Colorectal Neoplasms; Squamous Cell Carcinoma of Head and Neck; Carcinoma, Hepatocellular

Interventions

Injections

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Head and Neck Neoplasms; Adenocarcinoma; Liver Neoplasms; Liver Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Central Study Contacts

Jiawei Yao

CONTACT

+8618868816194; yaojiawei@zaiming.com

Study Design

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

Study Record Dates

• First Submitted: December 24, 2025
• First Posted: January 16, 2026
• Study Start: January 19, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): July 1, 2029
• Last Updated: January 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (7)