Phase 1 testing of SIM0686 for locally advanced or metastatic solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label, multicenter Phase 1 study administers SIM0686 to adults with histologically or cytologically confirmed locally advanced or metastatic solid tumors who have exhausted standard therapies. The primary focus is on safety, tolerability, and pharmacokinetics, with preliminary antitumor activity measured by RECIST v1.1 as a secondary outcome. Eligible participants must have ECOG 0–1, at least one measurable lesion, adequate organ and marrow function, and available archival or fresh tumor tissue for FGFR2b expression testing. The trial is being conducted at several cancer centers in China and uses dose-escalation methods typical of first-in-human/early-phase oncology studies.

Why it matters

Who can join: the full rules

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;

Where it's running

• Nanjing Tianyinshan Hospital
  Nanjing, Jiangsu, China Recruiting
• Shanghai Gobroad Cancer Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• Sichuan Cancer Hospital
  Chengdu, Sichuan, China Recruiting
• Cancer Hospital Chinese Academy of Medical Sciences
  Beijing, Beijing Municipality, China Not yet recruiting
• Harbin Medical University Cancer Hospital
  Haerbin, Heilongjiang, China Not yet recruiting
• The Affiliated Cancer Hospital of Zhengzhou University & Henan Cancer Hospital
  Zhengzhou, Henan, China Not yet recruiting

Study contacts

• Study coordinator: Zhi Zhang
• Email: zhangzhi4@zaiming.com
• Phone: +8618670738874

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• SIM0689 in adults with advanced solid tumors

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• SIM0613 in people with advanced solid tumors

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• Testing how SIM0270 interacts with itraconazole, rifampin, and midazolam in healthy Chinese adults

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.