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A First-in-human (FIH), Open-Label, Dose Escalation and Expansion Cohorts Study of MC002

23. juli 2026 oppdatert av: Hangzhou MacroLink Biopharmaceutical LLC

A First-in-human (FIH), Open-Label, Dose Escalation and Expansion Cohorts Study to Evaluate the Safety, Tolerability, Pharmacokinetic (PK) Characteristics, and Preliminary Efficacy of MC002 in Participants With Locally Advanced/Metastatic Solid Tumors

The goal of this clinical trial is to learn if ADC drug MC002 works to treat locally advanced/metastatic solid tumors in adults. It will also learn about the safety of MC002. The main questions it aims to answer are:

Does participants tolerate the drug MC002 ? What medical problems do participants have when treating with MC002? Does participants benefit from the MC002

.

Participants will:

Intravenous infusion MC002 every 3 weeks in clinical Visit the clinic once every 3 weeks for checkups and tests Keep a diary of their symptoms

Studieoversikt

Status

Har ikke rekruttert ennå

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

143

Fase

  • Fase 1

Kontakter og plasseringer

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

Studiekontakt

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

Nei

Beskrivelse

Inclusion Criteria:

  • 18 years of age and over, male or female, able to understand and willing to sign the Informed Consent Form (ICF).
  • Life expectancy of 3 month or greater
  • participants with histologically or cytologically confirmed recurrent or metastatic unresectable advanced solid tumors who experience disease progression after receiving systemic standard therapy, or have no standard therapy.
  • At least one measurable lesion as assessed by RECIST 1.1
  • Adequate organ functions.
  • ECOG Performance Status (PS) of 0-1

Exclusion Criteria:

  • Pregnant or nursing females.Participants who have received chemotherapy, investigational therapy, immunotherapy, or any other antitumor active drugs within 4 weeks or 5 half-lives (whichever is shorter) before the first dose.
  • Known hypersensitivity to either the drug substances or inactive ingredient
  • Participants who have undergone a bone marrow transplantation, solid organ transplantation, stem cell transplant.
  • Participants with QTc >470 msec.
  • Use of ≥10 mg of prednisone or equivalent dose of steroids per day within 3 months of administration (inhaled, intranasal, intraocular, topical and intraarticular joint injections of corticosteroids are allowed).Participants with a history of HCV infection who have not completed curative anti HCV treatment and whose HCV load is above the limit of quantification. Concurrent HCV treatment is not allowed in the trial.Live viral vaccine therapies within 4 weeks prior to the first dose of study drug.
  • Participants who have received treatment with any herbal or alternative therapies within 7 days prior to the first dose of the study drug.
  • Male and female participants of childbearing potential must be willing to completely abstain or agree to use a highly effective method of contraception

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: Sekvensiell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: dose escalation
MC002 dose escalation
MC002 is a recombinant antibody-drug conjugate targeting the oncofetal antigen.A complete treatment cycle is defined as 21 calendar days. MC002 will be administered as an intravenous (IV) solution on day 1 of each treatment cycle

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
To assess the Number of patients with Adverse Events (AE)
Tidsramme: From enrollmenFrom enrollment until 28 days after last study drug t to the safety follow up
Any medical event in a participant which may or may not have a causal relationship with this treatment.
From enrollmenFrom enrollment until 28 days after last study drug t to the safety follow up
Determination of MTD or RP2D
Tidsramme: From enrollment until 28 days after last study drug
Maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of MC002
From enrollment until 28 days after last study drug

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Maximum concentration (Cmax)
Tidsramme: From enrollment until 28 days after last study drug
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Cmax will be derived).
From enrollment until 28 days after last study drug
ADA
Tidsramme: From enrollment until 28 after last study drug
Incidence, onset time, and titer of ADAs against MC002
From enrollment until 28 after last study drug
The time taken to reach the maximum concentration (Tmax)
Tidsramme: From enrollment until 28 days after last study drug
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Tmax will be derived).
From enrollment until 28 days after last study drug
Area Under Curve (AUC)
Tidsramme: From enrollment until 28 days after last study drug
PK endpoint
From enrollment until 28 days after last study drug
Half life (T1/2)
Tidsramme: From enrollment until 28 days after last study drug
Half life (T1/2)
From enrollment until 28 days after last study drug
Trough concentration (Cmin)
Tidsramme: From enrollment until 28 days after last study drug
The concentration of MC002 (conjugated ADC), total mAb, and free payload (Cmin will be derived)
From enrollment until 28 days after last study drug

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall response rate (ORR)
Tidsramme: From enrollment until 28 days after last study drug.
the proportion/percentage of participants with best overall response of CR or PR。
From enrollment until 28 days after last study drug.
progression-free survival (PFS)
Tidsramme: From enrollment until 28 days after last study drug.
assessed per RECISTv1.1
From enrollment until 28 days after last study drug.

Samarbeidspartnere og etterforskere

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

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. september 2026

Primær fullføring (Antatt)

1. desember 2027

Studiet fullført (Antatt)

1. juni 2028

Datoer for studieregistrering

Først innsendt

10. juli 2026

Først innsendt som oppfylte QC-kriteriene

20. juli 2026

Først lagt ut (Faktiske)

24. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

27. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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