Phase I testing of SIM0609 in adults with advanced or metastatic solid tumors

A Phase I First-in-Human, Multicenter Study to Investigate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0609 in Adult Participants With Locally Advanced/Metastatic Solid Tumors

This trial tests SIM0609 to see if it is safe, tolerated, and can shrink tumors in adults with locally advanced or metastatic solid tumors who have exhausted standard treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 232 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Jiangsu Simcere Pharmaceutical Co., Ltd. (Industry-sponsored)
• Drugs / interventions: Radiation
• Locations: 6 sites (Beijing and 5 other locations)
• Trial ID: NCT07265921 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter Phase I trial gives escalating doses of SIM0609 to adults with histologically confirmed locally advanced or metastatic solid tumors to define safety, tolerability, and pharmacokinetics and to look for early signs of antitumor activity. After dose escalation, predefined dose-expansion cohorts will enroll patients with colorectal cancer, gastric/gastroesophageal junction cancer, pancreatic ductal adenocarcinoma, and other selected solid tumors. Key eligibility includes measurable disease, ECOG 0–1, adequate organ and marrow function, and available tumor tissue for biomarker analysis. Primary endpoints focus on safety and tolerability with secondary endpoints including pharmacokinetics and preliminary tumor response.

Who should consider this trial

Good fit: Adults aged 18 or older with histologically or cytologically confirmed locally advanced or metastatic solid tumors, measurable disease, ECOG performance status 0–1, adequate organ function, prior failure of standard therapies, and available tumor tissue are ideal candidates.

Not a fit: Patients with symptomatic central nervous system metastases, recent active second primary malignancies, poor performance status, or inadequate organ function are unlikely to benefit or be eligible for this trial.

Why it matters

Potential benefit: If successful, SIM0609 could offer a new treatment option that controls tumor growth for some patients whose cancers no longer respond to standard therapies.

How similar studies have performed: Early-phase trials of novel targeted agents have sometimes produced tumor shrinkage in selected patients but many candidates do not show durable benefit, so this approach remains exploratory.

Eligibility criteria

Inclusion Criteria:

1. Voluntary participation and signature of informed consent form;
2. At least 18 years old, male or female;
3. Participants with histologically and/or cytologically confirmed locally advanced/metastatic solid tumors;
4. Participants should have at least one evaluable or measurable tumor lesion;
5. Participants have failed the standard of therapy in the locally advanced/metastatic setting;
6. Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1;
7. Expected survival ≥12 weeks;
8. Adequate organ and bone marrow function;
9. Availability of archival formalin-fixed, paraffin-embedded (FFPE) tumor tissue, or fresh biopsies within 28 days before first administration, is mandatory

Exclusion Criteria:

1. 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;
2. Symptomatic central nervous system (CNS) metastases or CNS metastases requiring CNS-directed local therapy or corticosteroid treatment that occurred within 2 weeks prior to the first administration of the investigational treatment;
3. 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;
4. Presence of any serious or unstable concomitant systemic disorder incompatible with the clinical study ;
5. Any active infections requiring systemic therapy within 2 weeks prior to the initiation of the study treatment;
6. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring drainage or medical intervention within 4 weeks before the first dose of study treatment;
7. Not recovered from previous anticancer therapy-induced AEs(Adverse Events);
8. Currently participating or has participated in a study of an investigational agent or using an investigational device within 4 weeks of first dose of study treatment;
9. Received prior therapies within the following time frames prior to the first dose of study treatment:

   1. Previous cytotoxic therapy, anticancer targeted small molecules 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.
10. Prior exposure to topoisomerase I inhibitor (TOP1i)-based antibody drug conjugate (ADC) therapies or CDH17-targeted ADC therapies.
11. Use of any live vaccine therapy within 4 weeks prior to the first dose of study treatment.
12. Administration of below medications ≤14 days prior to the first dose of study treatment.

    1. Strong or moderate CYP3A4 inducers/inhibitors;
    2. Drugs with known risk of Torsades de Pointes(TdP);
    3. Drugs that may prolong the QT interval;
13. Major surgery within 2 weeks of receiving the first dose of study treatment;
14. Known human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome ;
15. Active or chronic hepatitis B or hepatitis C infection;
16. Participants with clinically significant cardiovascular diseases;
17. History of allogeneic organ transplantation or graft-versus-host disease;
18. History of hypersensitivity to active or inactive excipients of SIM0609 or drugs with a similar chemical structure or class to SIM0609;
19. Pregnant or nursing (lactating) women;
20. Male participants with female partners of reproductive potential, unless they are using highly effective contraceptive methods from signing of informed consent to 180 days after the last dose of study treatment;
21. Presence of any other condition that may increase the risk associate with study participant or may interfere with the interpretation of study results, and, in the opinion of the Investigator, would make the participant inappropriate for entry into the study.

Where this trial is running

Beijing and 5 other locations

• Beijing Cancer Hospital — Beijing, China (Recruiting)
• Jiangsu Province Hospital — Nanjing, China (Not_yet_recruiting)
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Not_yet_recruiting)
• Zhongshan Hospital，Fudan University — Shanghai, China (Not_yet_recruiting)
• Tianjin Cancer Hospital — Tianjin, China (Not_yet_recruiting)
• Hubei Cancer Hospital — Wuhan, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Jinxiu Zhang

Conditions Advanced Solid Cancer