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

NCT07050459 | Recruiting Phase 1

• 1 other identifier: SIM0686-101
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 10

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

Conditions

Locally Advanced Solid Tumors

Outcome Measures

Primary Outcomes (3)

• Dose escalation: Dose limited toxicity (DLT)

  DLTs are assessed during the DLT observation period to determine maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D).

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

• Dose escalation phase: Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Adverse events will be assessed by investigator(s) according to NCI-CTCAE v5.0.

  The whole dose escalation phase，an average of 2 years

• Cohort expansion phase：Overall Response Rate (ORR)

  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)

  The whole Cohort expansion phase，an average of 2 years

Study Arms (2)

SIM0686 momo Dose escalation

EXPERIMENTAL

Sequential cohorts of increasing dose levels of SIM0686 will be evaluated as monotherapy

Drug: SIM0686

SIM0686 Corhort expansion

EXPERIMENTAL

Recommended Dose(s) of SIM0686 as determined from Part1 will be evaluated in select indications

Drug: SIM0686

Interventions

SIM0686 DRUG

Administered intravenously

SIM0686 Corhort expansion

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 (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

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.
• 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:
• Previous cytotoxic therapy, anticancer targeted small molecules (e.g., tyrosine kinase inhibitors) 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 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;

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (10)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

NOT YET RECRUITING

Harbin Medical University Cancer Hospital

Haerbin, Heilongjiang, 150081, China

NOT YET RECRUITING

The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital

Zhengzhou, Henan, 450003, China

NOT YET RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410017, China

NOT YET RECRUITING

Nanjing Tianyinshan Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

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

Jinan, Shandong, 250117, China

NOT YET RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

NOT YET RECRUITING

Shanghai Gobroad Cancer Hospital

Shanghai, Shanghai Municipality, 200131, China

RECRUITING

Sichuan Cancer Hospital

Chengdu, Sichuan, 610040, China

RECRUITING

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

NOT YET RECRUITING

Central Study Contacts

Zhi Zhang

CONTACT

+8618670738874; zhangzhi4@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: May 27, 2025
• First Posted: July 3, 2025
• Study Start: May 20, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 3, 2025

Record last verified: 2025-07

Locations

CN (10)