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A Study of SIM0689 in Adult Participants With Locally Advanced or Metastatic Solid Tumors

18. august 2026 opdateret af: Jiangsu Simcere Pharmaceutical Co., Ltd.

Phase I First-in-Human, Open-label, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Antitumor Activity of SIM0689 in Adult Participants With Locally Advanced or Metastatic Solid Tumors

This study will evaluate the safety, of SIM0689 and how the body processes it, how it affects the body, and its early signs of activity against tumors when given alone to Adult Participants with Locally Advanced or Metastatic Solid Tumors. The study has a dose escalation part to find the highest dose that can be given safely, or recommended dose (RD) for SIM0689 when given alone, and a dose expansion part in subjects with specific tumor types treated with SIM0689 as a single agent at RD.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

472

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Kina
    • Fujian
      • Fuzhou, Fujian, Kina, 350014
        • Rekruttering
        • Fujian Cancer Hospital
        • Kontakt:
          • Zengqing Guo
    • Henan
      • Zhengzhou, Henan, Kina, 450000
        • Ikke rekrutterer endnu
        • The First Affiliated Hospital of Zhengzhou University
        • Kontakt:
          • Shuiling Jin
    • Hunan
      • Changsha, Hunan, Kina, 410013
        • Ikke rekrutterer endnu
        • Hunan Cancer Hospital
        • Kontakt:
          • Haiyan Yang
        • Kontakt:
          • Xingxiang Pu
    • Liaoning
      • Shenyang, Liaoning, Kina, 110000
        • Ikke rekrutterer endnu
        • The First Hospital of China Medical University
        • Kontakt:
          • Yunpeng Liu
    • Shandong
      • Jinan, Shandong, Kina, 250117
        • Ikke rekrutterer endnu
        • Cancer Hospital of Shandong First Medical University
        • Kontakt:
          • Shuqin Ni
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310003
        • Rekruttering
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Kontakt:
          • Tingbo Liang

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

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Ingen

Beskrivelse

Inclusion Criteria:

  • In dose-escalation cohorts (Part 1), histologically or cytologically documented advanced or metastatic solid tumor that is refractory/relapsed to standard therapies, or for which no effective standard therapy is available, or the subject refuses standard therapy.
  • In the dose-expansion cohorts (Part 2), histologically or cytologically confirmed selected advanced solid tumors.
  • Subjects must have at least one measurable lesion according to RECIST Version1.1.
  • Eastern Cooperative Oncology Group (ECOG) Performance Score of 0 or 1.
  • Adequate organ function.
  • Available archived tumor tissue sample to allow for correlative biomarker studies. If unavailable or unsuitable, the subject must consent and undergo fresh tumor biopsy.
  • Life expectancy ≥12 weeks.
  • Patients of childbearing potential (male and female) must agree to use reliable methods of contraception until at least 180 days after the last dose.

Exclusion Criteria:

  • Symptomatic brain metastases.
  • Serious non-healing wounds, ulcers or fractures.
  • Toxicity from previous treatment has to restore to ≤ grade 1.
  • Major surgery (excluding biopsy) or significant trauma within 4 weeks prior to enrollment.
  • Use of aspirin (> 325 mg/day) within 6 months prior to the first dose.
  • Active hepatitis B or hepatitis C.
  • Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
  • Known hereditary or acquired predisposition to bleeding and thrombosis.
  • History of gastrointestinal perforation, gastrointestinal bleeding, fistula, or any life-threatening bleeding event within 6 months prior to enrollment.
  • Prior permanent discontinuation of PD-(L)1 and/or VEGF monoclonal antibody because of immune/anti-angiogenesis toxicities, or history of Grade ≥3 immune/anti-angiogenesis-related AEs
  • Known or suspected active autoimmune disease.
  • Patients with proteinuria at screening (Urine protein >2+ at screening, or 2+ urine protein accompanied by 24-h urine protein ≥1 g/24 h).
  • History of myocardial infarction or stroke within 6 months prior to enrollment.
  • Subjects with clinically significant cardiovascular disease within 6 months prior to the first dose.
  • Pregnant and lactating women.
  • Known allergies to any excipient in the study drug.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: SIM0689 for Injection
One intravenous infusion of SIM0689 for Injection, 28 days or 21 days as a treatment cycle.
Medicin: SIM0689 for Injection
SIM0689 for Injection is a Programmed Cell Death Protein 1(PD1) / Vascular Endothelial Growth Factor (VEGF) bispecific antibody.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Dose-limiting toxicity (DLT) (Dose escalation)
Tidsramme: at the end of Cycle 1 (each cycle is 28 days)
DLTs will be assessed during the dose-escalation phase and are defined as toxicities that meet pre-defined severity criteria.
at the end of Cycle 1 (each cycle is 28 days)
Maximum tolerated dose (MTD)and / or Recommended dose (RD) (Dose escalation)
Tidsramme: Up to approximately 2 years

The MTD is defined as the dose of SIM0689 with an estimated toxicity rate closest to the target toxicity rate of 27%；

RD stands for Recommended Dose, which will be selected based on the evaluation of all available pharmacokinetics, pharmacodynamic, efficacy, safety, and tolerability data
Up to approximately 2 years
Objective Response Rate (ORR) (Dose expansion)
Tidsramme: Up to approximately 2 years
ORR is the proportion of participants with complete response(CR)or partial response (PR) assessed according to RECIST v1.1.
Up to approximately 2 years

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Adverse event rate
Tidsramme: up to approximately 2 years
The occurrence of all adverse events (AEs), evaluated by Common Terminology Criteria for Adverse Events (CTCAE) 6.0.
up to approximately 2 years
Pharmacokinetics: The area under the curve (AUC)
Tidsramme: up to approximately 2 years
The area under the curve (AUC) of serum concentration of SIM0689
up to approximately 2 years
Pharmacokinetics: Peak concentration (Cmax)
Tidsramme: Up to approximately 2 years
Maximum observed concentration (Cmax) of SIM0689
Up to approximately 2 years
Pharmacokinetics: T1/2
Tidsramme: Up to approximately 2 years
Terminal half-life (T1/2)
Up to approximately 2 years
Pharmacokinetics: Tmax
Tidsramme: Up to approximately 2 years
Time to maximum concentration
Up to approximately 2 years
Immunogenicity
Tidsramme: Up to approximately 2 years
Titer of serum anti-SIM0689 antibodies
Up to approximately 2 years
Immunogenicity
Tidsramme: Up to approximately 2 years
Incidence rate of serum anti-SIM0689 antibodies
Up to approximately 2 years
Immunogenicity
Tidsramme: Up to approximately 2 years
Duration of serum anti-SIM0689 antibodies
Up to approximately 2 years

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Jiangsu Simcere Pharmaceutical Co., Ltd.

Samarbejdspartnere

Shanghai Xianwei Medical Technology Co., Ltd.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

3. juli 2026

Primær færdiggørelse (Anslået)

1. december 2028

Studieafslutning (Anslået)

1. juni 2029

Datoer for studieregistrering

Først indsendt

10. juni 2026

Først indsendt, der opfyldte QC-kriterier

16. juni 2026

Først opslået (Faktiske)

22. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

20. august 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. august 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • SIM0689-101

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