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A Phase I Study of SIM0686 in Participants With Locally Advanced/Metastatic Solid Tumors | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Phase I Study of SIM0686 in Participants With Locally Advanced/Metastatic Solid Tumors

A Phase I First-in-Human, Open-label, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0686 in Adult Participants With Locally Advanced/Metastatic Solid Tumors

NCT07050459•Jiangsu Simcere Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

This is an open-label, multicenter phase 1 study to evaluate the safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0686 in Adult Participants with Locally Advanced/Metastatic Solid Tumors

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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 (RECIST v1.1);
•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 6 months before first administration for evaluation of FGFR2b expression levels

Exclusion Criteria

•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.
•Participant has symptomatic central nervous system (CNS) metastases, or CNS metastases requiring CNS-directed local therapy (such as radiotherapy or surgery) or corticosteroids therapy within 2 weeks of first dose of study treatment.
•Active or chronic corneal disorder, history of corneal transplantation, keratitis, keratoconjunctivitis, keratopathy, keratoconus, corneal abrasion, inflammation or ulceration, other active ocular conditions and any clinically significant corneal disease that prevents adequate monitoring of drug-induced keratopathy.
•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.
•Participant has not recovered (i.e., to Grade 1 or to baseline) from previous anticancer therapy-induced AEs.
•Has received prior therapies within the following time frames prior to the first dose of study treatment:
•1. Previous cytotoxic therapy, anticancer targeted small molecules (e.g., tyrosine kinase inhibitors) within 2 weeks.
•2. Anti-cancer antibody, immune checkpoint inhibitor or ADC within 5 half-lives or 4 weeks (whichever is shorter).
•3. Chinese medicines/herbal preparations with anticancer indication taken within 2 weeks.
•4. Radiation therapy within 4 weeks.
+3 more criteria

Locations (10)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Harbin Medical University Cancer Hospital

Haerbin, Heilongjiang, China

The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Zhengzhou, Henan, China

Hunan Cancer Hospital

Changsha, Hunan, China

Nanjing Tianyinshan Hospital

Nanjing, Jiangsu, China

Cancer Hospital of Shandong First Medical University（Shandong Cancer Hospital&Institute）

Jinan, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Shanghai Gobroad Cancer Hospital

Shanghai, Shanghai Municipality, China

Sichuan Cancer Hospital

Chengdu, Sichuan, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Key Dates

Start Date

May 20, 2025

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2028

Last Updated

July 3, 2025

Enrollment

220

ESTIMATED participants

Conditions

Locally Advanced Solid Tumors

Interventions

SIM0686

DRUG

SIM0686

DRUG

Contacts

Zhi Zhang

CONTACT

+8618670738874 zhangzhi4@zaiming.com

A Study of IMC-001 In Patients With Metastatic Or Locally Advanced TMB-H Solid Tumor

NCT06365840

TMB-HHistologically or Cytologically Proven Metastatic or Locally Advanced Solid Tumors

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 3, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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