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

29 april 2026 uppdaterad 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

96

Fas

  • Fas 1

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

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

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Number of participants with a Dose Limiting Toxicity (DLT)
Tidsram: 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)
Tidsram: 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.

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Serum PK concentration of AK150
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Akeso

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

30 april 2026

Primärt slutförande (Beräknad)

21 februari 2029

Avslutad studie (Beräknad)

7 juni 2029

Studieregistreringsdatum

Först inskickad

29 april 2026

Först inskickad som uppfyllde QC-kriterierna

29 april 2026

Första postat (Faktisk)

5 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 maj 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

29 april 2026

Senast verifierad

1 april 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • AK150-101

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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