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A Study of DXC016 in Patients With Advanced Solid Tumors.

9 november 2026 uppdaterad 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

170

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
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510050
        • Sun Yat-sen University Cancer Center
        • Kontakt:
          • 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
        • Kontakt:
          • 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
        • Kontakt:
          • Yong Li, MD (Doctor of Medicine)
          • Telefonnummer: +086-0791-8631933
          • E-post: liyongcsco@qq.com
        • Kontakt:
    • Shanxi
      • Taiyuan, Shanxi, Kina, 030000
        • Shanxi Cancer Hospital
        • Kontakt:
          • Hongxia Lu, Master of Medicine
          • Telefonnummer: +086-0351-4881611
          • E-post: 53473139@qq.com
        • Kontakt:
          • Wang Xin, MD (Doctor of Medicine)
          • Telefonnummer: +086-0351-4881611
          • E-post: WXCAMS@126.com
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310022
        • Zhejiang Cancer Hospital
        • Kontakt:
          • 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
        • Kontakt:
          • Haizhou Lou, MD (Doctor of Medicine)
          • Telefonnummer: +086-0571-86090073
          • E-post: louhz09@163.com

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

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

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: Icke-randomiserad
  • Interventionsmodell: Sekventiell tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Kohort B
Läkemedel: Cohort B: DXC016 dose expansion

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

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Incidence and severity of adverse events (AEs)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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

Samarbetspartners och utredare

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

Sponsor

Hangzhou DAC Biotechnology Co., Ltd.

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)

1 december 2026

Primärt slutförande (Beräknad)

1 december 2030

Avslutad studie (Beräknad)

1 juni 2031

Studieregistreringsdatum

Först inskickad

3 november 2026

Först inskickad som uppfyllde QC-kriterierna

9 november 2026

Första postat (Faktisk)

12 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

12 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

9 november 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Andra studie-ID-nummer

  • DXC016-001

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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