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

Not Applicable

Recruiting

• Conditions: Locally Advanced Solid Tumors
• Interventions: Drug: SIM0686

• Registration Number: NCT07050459
• Lead Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd.

Brief 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

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-20
• Study First Submitted: 2025-05-27
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-02
• Last Update Submitted: 2025-07-02
• Study First Posted: 2025-07-03
• Last Update Posted: 2025-07-03
• Primary Completion: 2027-12
• Study Completion: 2028-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 220

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.

• Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody-drug conjugate (ADC) therapies or FGFR2b-targeted ADC therapies.

• Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS).

• Active or chronic hepatitis B or hepatitis C infection;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
SIM0686 momo Dose escalation	SIM0686	Sequential cohorts of increasing dose levels of SIM0686 will be evaluated as monotherapy
SIM0686 Corhort expansion	SIM0686	Recommended Dose(s) of SIM0686 as determined from Part1 will be evaluated in select indications

Primary Outcome Measures

Name	Time	Method
Dose escalation: Dose limited toxicity (DLT)	At the end of Cycle 1(each cycle is 21 days)	DLTs are assessed during the DLT observation period to determine maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).
Cohort expansion phase：Overall Response Rate (ORR)	The whole Cohort expansion phase，an average of 2 years	ORR is defined as the percentage of participants with confirmed complete response (CR) or partial response (PR) by Response Evaluations Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Dose escalation phase: Adverse Events (AEs) and Serious Adverse Events (SAEs)	The whole dose escalation phase，an average of 2 years	Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0.

Trial Locations

Locations (10)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, 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, China

Shanghai Gobroad Cancer Hospital; 🇨🇳 Shanghai, Shanghai, China

Sichuan Cancer Hospital; 🇨🇳 Chengdu, Sichuan, China

Tianjin Cancer Hospital; 🇨🇳 Tianjin, Tianjin, China