A Study of DXC016 in Patients With Advanced Solid Tumors.
9 november 2026 bijgewerkt door: 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.
Studie Overzicht
Toestand
Nog niet aan het werven
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Geschat)
170
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Pengyu Shi
- Telefoonnummer: +086-0571-56050590
- E-mail: Shipengyu@dacbiotech.com
Studie Locaties
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Guangdong
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Guangzhou, Guangdong, China, 510050
- Sun Yat-sen University Cancer Center
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Contact:
- Ruihua Xu, MD (Doctor of Medicine)
- Telefoonnummer: +086-020-87343468
- E-mail: xurh@sysucc.org.cn
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Guangxi
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Nanning, Guangxi, China, 530200
- Guangxi Medical University Cancer Hospital
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Contact:
- Yongqiang Li, Master of Medicine
- Telefoonnummer: +086-0771-5331955
- E-mail: lyq702702@126.com
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Jiangxi
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Nanchang, Jiangxi, China, 330052
- The First Affiliated Hospital of Nanchang University
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Contact:
- Yong Li, MD (Doctor of Medicine)
- Telefoonnummer: +086-0791-8631933
- E-mail: liyongcsco@qq.com
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Contact:
- Pu Li, MD (Doctor of Medicine)
- Telefoonnummer: +086-0791-8631933
- E-mail: 13970998685@163.com
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Shanxi
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Taiyuan, Shanxi, China, 030000
- Shanxi Cancer Hospital
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Contact:
- Hongxia Lu, Master of Medicine
- Telefoonnummer: +086-0351-4881611
- E-mail: 53473139@qq.com
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Contact:
- Wang Xin, MD (Doctor of Medicine)
- Telefoonnummer: +086-0351-4881611
- E-mail: WXCAMS@126.com
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Zhejiang
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Hangzhou, Zhejiang, China, 310022
- Zhejiang Cancer Hospital
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Contact:
- Ji Zhu, MD (Doctor of Medicine)
- Telefoonnummer: +086-0571-88122222
- E-mail: zhuji@zjcc.org.cn
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Hangzhou, Zhejiang, China, 310016
- Sir Run Run Shaw Hospital, affiliated with Zhejiang University School of Medicine
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Contact:
- Haizhou Lou, MD (Doctor of Medicine)
- Telefoonnummer: +086-0571-86090073
- E-mail: louhz09@163.com
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Inclusion Criteria:
- Patients must be able to provide documented voluntary informed consent and be aged ≥ 18 years.
- 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.
- Measurable disease defined by RECIST version 1.1.
- ECOG 0-1.
- Life expectancy ≥ 3 months.
- Must have adequate organ function.
- 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.
- 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.
- Able to provide a tumor tissue specimen.
Exclusion Criteria:
- Has a history of any other malignancy.
- Has active central nervous system (CNS) involvement.
- Has uncontrolled third-space fluid accumulation (e.g., pleural effusion, ascites, or pericardial effusion).
- Has had an active autoimmune disease requiring systemic immunosuppressive therapy within 12 months prior to signing the informed consent form.
- Has an active infection or medical condition requiring systemic antibiotic therapy within 7 days prior to the first dose of the study drug.
- Known human immunodeficiency virus (HIV) infection.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
- Uncontrolled or clinically significant cardiovascular or cerebrovascular disease.
- Currently has active, non-infectious interstitial lung disease (ILD)/pneumonitis requiring systemic corticosteroid treatment, etc..
- Toxicities related to prior antineoplastic therapy that have not resolved to ≤ Grade 1 or returned to baseline.
- Known allergy, hypersensitivity, or intolerance to DXC016 or any of its excipients.
- Has undergone major surgery within 30 days prior to the first dose of study treatment, or has not yet recovered from the surgery.
- Inadequate washout period from prior therapy prior to the first dose of the study drug.
- 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.
- 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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Sequentiële toewijzing
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Cohort B
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Subcutaneous (SC) administration (QW, Q2W or Q3W) |
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Experimenteel: Cohort A
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Subcutaneous (SC) administration (QW, Q2W or Q3W) |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Incidence and severity of adverse events (AEs)
Tijdsspanne: From subject sign the informed consent form (ICF) to 30 days after the last dose of study treatment
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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)
Tijdsspanne: Assess approximately 12 months
|
To determine the maximum tolerated dose (MTD) and the recommended dose for expansion (RDE) of DXC016 |
Assess approximately 12 months
|
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Recommended Doses for phase 2 (RP2D)
Tijdsspanne: 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
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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
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
1 december 2026
Primaire voltooiing (Geschat)
1 december 2030
Studie voltooiing (Geschat)
1 juni 2031
Studieregistratiedata
Eerst ingediend
3 november 2026
Eerst ingediend dat voldeed aan de QC-criteria
9 november 2026
Eerst geplaatst (Werkelijk)
12 november 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
12 november 2026
Laatste update ingediend die voldeed aan QC-criteria
9 november 2026
Laatst geverifieerd
1 augustus 2026
Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- DXC016-001
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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