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A Study of DXC016 in Patients With Advanced Solid Tumors.

9. november 2026 oppdatert av: Hangzhou DAC Biotechnology Co., Ltd.

A Phase I, Multicenter, Open-Label, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetic Profile, and Preliminary Efficacy of DXC016 in Participants With Advanced Solid Tumors.

The investigational product DXC016 is an antibody-drug conjugate (ADC) targeting c-Met. Preclinical studies have demonstrated definitive antitumor activity and a manageable safety profile. On this basis, this first-in-human trial will be conducted in participants with advanced solid tumors to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary antitumor activity of DXC016, with the aim of determining the recommended Phase II dose (RP2D) and identifying the population most likely to benefit, thereby informing subsequent clinical development.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

170

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
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510050
        • Sun Yat-sen University Cancer Center
        • Ta kontakt med:
          • Ruihua Xu, MD (Doctor of Medicine)
          • Telefonnummer: +086-020-87343468
          • E-post: xurh@sysucc.org.cn
    • Guangxi
      • Nanning, Guangxi, Kina, 530200
        • Guangxi Medical University Cancer Hospital
        • Ta kontakt med:
          • Yongqiang Li, Master of Medicine
          • Telefonnummer: +086-0771-5331955
          • E-post: lyq702702@126.com
    • Jiangxi
      • Nanchang, Jiangxi, Kina, 330052
        • The First Affiliated Hospital of Nanchang University
        • Ta kontakt med:
          • Yong Li, MD (Doctor of Medicine)
          • Telefonnummer: +086-0791-8631933
          • E-post: liyongcsco@qq.com
        • Ta kontakt med:
    • Shanxi
      • Taiyuan, Shanxi, Kina, 030000
        • Shanxi Cancer Hospital
        • Ta kontakt med:
          • Hongxia Lu, Master of Medicine
          • Telefonnummer: +086-0351-4881611
          • E-post: 53473139@qq.com
        • Ta kontakt med:
          • Wang Xin, MD (Doctor of Medicine)
          • Telefonnummer: +086-0351-4881611
          • E-post: WXCAMS@126.com
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310022
        • Zhejiang Cancer Hospital
        • Ta kontakt med:
          • Ji Zhu, MD (Doctor of Medicine)
          • Telefonnummer: +086-0571-88122222
          • E-post: zhuji@zjcc.org.cn
      • Hangzhou, Zhejiang, Kina, 310016
        • Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine
        • Ta kontakt med:
          • Haizhou Lou, MD (Doctor of Medicine)
          • Telefonnummer: +086-0571-86090073
          • E-post: louhz09@163.com

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  1. Patients must be able to provide documented voluntary informed consent and be aged ≥ 18 years.
  2. Participants with histologically or cytologically confirmed locally advanced unresectable or metastatic colorectal cancer, gastric adenocarcinoma / gastroesophageal junction adenocarcinoma, pancreatic ductal adenocarcinoma, non-small cell lung cancer, hepatocellular carcinoma, cholangiocarcinoma, or other solid tumors, who have experienced disease progression during standard therapy, are intolerant of standard therapy, or have no standard therapy available.
  3. Measurable disease defined by RECIST version 1.1.
  4. ECOG 0-1.
  5. Life expectancy ≥ 3 months.
  6. Must have adequate organ function.
  7. Female participants of childbearing potential (WOCBP) must agree to use highly effective contraceptive methods from screening, throughout the study period, and for at least 6 months after the last dose of the study drug, and must not donate ova or undergo oocyte retrieval for their own use. Male participants must agree to use highly effective contraceptive methods from screening, throughout the study period, and for at least 6 months after the last dose of the study drug, and must not cryopreserve or donate sperm.
  8. Additional inclusion criteria for the dose expansion phase must be met, including requirements regarding tumor-type-specific disease history, number of prior lines of therapy, etc.
  9. Able to provide a tumor tissue specimen.

Exclusion Criteria:

  1. Has a history of any other malignancy.
  2. Has active central nervous system (CNS) involvement.
  3. Has uncontrolled third-space fluid accumulation (e.g., pleural effusion, ascites, or pericardial effusion).
  4. Has had an active autoimmune disease requiring systemic immunosuppressive therapy within 12 months prior to signing the informed consent form.
  5. Has an active infection or medical condition requiring systemic antibiotic therapy within 7 days prior to the first dose of the study drug.
  6. Known human immunodeficiency virus (HIV) infection.
  7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  8. Uncontrolled or clinically significant cardiovascular or cerebrovascular disease.
  9. Currently has active, non-infectious interstitial lung disease (ILD)/pneumonitis requiring systemic corticosteroid treatment, etc..
  10. Toxicities related to prior antineoplastic therapy that have not resolved to ≤ Grade 1 or returned to baseline.
  11. Known allergy, hypersensitivity, or intolerance to DXC016 or any of its excipients.
  12. Has undergone major surgery within 30 days prior to the first dose of study treatment, or has not yet recovered from the surgery.
  13. Inadequate washout period from prior therapy prior to the first dose of the study drug.
  14. Prior treatment with c-Met-targeted therapies (including antibodies, ADCs, chimeric antigen receptor T-cell [CAR-T] therapy, and other agents), with the exception that prior treatment with c-Met-targeted tyrosine kinase inhibitors (TKIs) is permitted.
  15. Any disease, medical condition, organ system dysfunction, or social situation that, in the opinion of the investigator, may interfere with the participant's ability to sign the informed consent form, adversely affect the participant's ability to cooperate and participate in the study, or compromise the interpretation of study results.

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: Ikke-randomisert
  • Intervensjonsmodell: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Kohort B
Legemiddel: Cohort B: DXC016 dose expansion

Subcutaneous (SC) administration (QW, Q2W or Q3W)
Eksperimentell: Kohort A
Legemiddel: Cohort A: DXC016 dose escalation

Subcutaneous (SC) administration (QW, Q2W or Q3W)

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Incidence and severity of adverse events (AEs)
Tidsramme: From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment

Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v6.0
From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment
Maximum Tolerated Dose (MTD) and Recommended Doses for Expansion (RDEs)
Tidsramme: Assess approximately 12 months

To determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of DXC016
Assess approximately 12 months
Recommended Doses for phase 2 (RP2D)
Tidsramme: from the date of informed consent until 30 days after last infusion of study drug or begin a new anti cancer therapy, whichever occurs first

To determine the Recommended Doses for phase 2 (RP2D) of DXC016
from the date of informed consent until 30 days after last infusion of study drug or begin a new anti cancer therapy, whichever occurs first

Samarbeidspartnere og etterforskere

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

Sponsor

Hangzhou DAC Biotechnology Co., Ltd.

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)

1. desember 2026

Primær fullføring (Antatt)

1. desember 2030

Studiet fullført (Antatt)

1. juni 2031

Datoer for studieregistrering

Først innsendt

3. november 2026

Først innsendt som oppfylte QC-kriteriene

9. november 2026

Først lagt ut (Faktiske)

12. november 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

12. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

9. november 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • DXC016-001

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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