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A Phase I Clinical Study of AK150 in Advanced Malignant Solid Tumor

29. april 2026 oppdatert av: Akeso

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of AK150 in Advanced Malignant Solid Tumor

This study is an open-label, multicenter, dose-escalation and dose-expansion Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary antitumor activity of AK150 in patients with advanced malignant solid tumors.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

96

Fase

  • Fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Kina
    • Fujian
      • Fuzhou, Fujian, Kina, 350014
        • Fujian Cancer Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Zhang'zhou Huang, M.D.
    • Guangdong
      • Dongguan, Guangdong, Kina, 523000
        • Dongguan People's Hospital
        • Hovedetterforsker:
          • Ruinian Zheng, M.D.
        • Ta kontakt med:
        • Underetterforsker:
          • Jingtang Chen, M.D.
    • Hubei
      • Wuhan, Hubei, Kina, 430040
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Hovedetterforsker:
          • Tao Zhang, M.D.
        • Ta kontakt med:
        • Ta kontakt med:
        • Underetterforsker:
          • Xiaorong Dong, M.D.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Be able to understand and voluntarily sign the written informed consent form.
  2. Aged of ≥ 18 years and ≤75 years.
  3. ECOG PS 0 or 1.
  4. The expected lifespan is ≥3 months.
  5. 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 is not suitable for standard therapy.
  6. At least one measurable lesion according to RECIST v1.1.
  7. Adequate organ function.
  8. Females subjects must not be pregnant at screening or have evidence of non-childbearing potential. Agree to use medically accepted methods of contraception

Exclusion Criteria:

  1. Having other active malignancies within 3 years.
  2. Currently participating in another interventional clinical study.
  3. Presence of active metastases to the central nervous system. For participants with asymptomatic brain metastasis or stable symptoms after treatment can be included.
  4. Having received any treatment targeting CSF-1R, ILT2 and ILT4..
  5. Having received systemic anti-tumor treatment within 28 days or major surgical operations are expected to be required during the study period.
  6. Toxicity of previous antineoplastic therapy has not resolved to NCI CTCAE 6.0 grade 1 or lower.
  7. Participants with clinically significant cardiovascular or cerebrovascular diseases or risks.
  8. Participants with active autoimmune diseases requiring systemic treatment within 2 years.
  9. Active infections, including those requiring intravenous antibiotics and antifungal treatment 2 weeks before the administration of the study, and unexplained fever during the screening period.
  10. Known to be positive for HIV and other infections.
  11. Live attenuated vaccines were received within 28 days.

13. Participants with a history of mental illness and incapacitated or limited capacity.

14. Women who are pregnant or lactating. 15.Known history of active tuberculosis. 16.Currently enrolled in any other clinical study. 17.Any disease or condition that, in the opinion of the investigator, would compromise participant safety or interfere with study assessments.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: AK150
Each subject will receive a single dose of AK150 every 2-week cycle (Q2W).
Legemiddel: AK150
IV infusion, administered on Day 1 of each cycle, Q2W,continuous treatment

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Number of participants with a Dose Limiting Toxicity (DLT)
Tidsramme: During the first 4 weeks
DLTs will be assessed during the first 4 weeks of treatment for dose-escalation I phase and are defined as toxicities that meet pre-defined severity criteria, and assessed as having a suspected relationship to study drug, and unrelated to disease, disease progression, inter-current illness, or concomitant medications that occurs within the first 2 cycles (4 weeks) of treatment
During the first 4 weeks
Number of participants with adverse events (AEs)
Tidsramme: From the participant signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first.
An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product temporally associated with the use of study treatment, whether or not considered related to the study treatment
From the participant signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anti-tumor therapy, whichever occurs first.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Serum PK concentration of AK150
Tidsramme: From pre-dose to the end of the last dose, an average of 6 months.
Serum PK of AK150 at different timepoints after AK150 administration
From pre-dose to the end of the last dose, an average of 6 months.
The immunogenicity of AK150
Tidsramme: From pre-dose to 30 days post end of treatment
The immunogenicity of AK150 will be assessed by summarizing the number of participants who develop detectable anti-drug antibodies (ADAs)
From pre-dose to 30 days post end of treatment
Overall response rate (ORR)
Tidsramme: Up to 12 year.
Efficacy measures such as ORR, which is the proportion of participants with CR or PR by investigator based on RECIST v1.1
Up to 12 year.
Progression-Free Survival(PFS)
Tidsramme: Up to 1 year
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first assessed by investigator Per RECIST 1.1.
Up to 1 year
Disease control rate(DCR)
Tidsramme: Up to 1 year.
DCR, which is defined as the proportion of subjects with CR, PR, or SD, based on RECIST v1.1.
Up to 1 year.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Akeso

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

30. april 2026

Primær fullføring (Antatt)

21. februar 2029

Studiet fullført (Antatt)

7. juni 2029

Datoer for studieregistrering

Først innsendt

29. april 2026

Først innsendt som oppfylte QC-kriteriene

29. april 2026

Først lagt ut (Faktiske)

5. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. mai 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

29. april 2026

Sist bekreftet

1. april 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • AK150-101

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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