Pharmacokinetic (PK) Study of QL1203 and Vectibix® for the Treatment of RAS Wild-type Metastatic Colorectal Cancer
A Randomized, Double-Blind, Parallel-Controlled, Multicenter Phase I Study to Evaluate the Pharmacokinetic Similarity Between QL1203 (Vectibix® Biosimilar Candidate) and Panitumumab (EU-Vectibix®) in Combination With mFOLFOX6 Respectively in Patients With RAS Wild-Type Metastatic Colorectal Cancer
This is a randomized, double-blind, parallel-controlled, multicenter clinical trial to evaluate the pharmacokinetic similarity between QL1203 and Vectibix® in patients with RAS wild-type metastatic colorectal cancer. Eligible trial participants will be randomized in a 1:1 ratio to either the QL1203 or Vectibix® groups, to received QL1203 + mFOLFOX6 and the control group received Vectibix® + mFOLFOX6. PK profiles, immunogenicity, safety and preliminary efficacy will be evaluated and compared between two groups .
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Fase 1
Kontakter og plasseringer
Studiekontakt
- Navn: Jing Xie, Master
- Telefonnummer: 13811865963
- E-post: jing5.xie@qilu-pharma.com
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Voluntarily participate, have read, understood and signed the informed consent form (ICF), and are able to follow the study procedures.
- Male or female aged ≥18 years.
- Metastatic colorectal adenocarcinoma confirmed by histology or cytology, and not suitable for radical surgery, radiotherapy, radiofrequency ablation and other local treatments.
- Wild-type RAS and wild-type BRAF.
- At least 1 definite measurable tumor lesion according to RECIST v1.1.
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score 0-1.
- Have adequate organ function.
Exclusion Criteria:
- Previous systemic treatment: The time from the last dose of neoadjuvant or adjuvant therapy to disease recurrence is > 6 months.
- Previous treatment with epidermal growth factor receptor (EGFR) targeted drugs for colorectal cancer.
- Trial participants known to have high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR).
- Presence of active central nervous system metastases.
- Participants with a history of malignancies other than colorectal cancer within 5 years prior to the first dose.
- Trial participants (both male and female) who are unwilling to accept effective contraception; female trial participants who are pregnant or breastfeeding.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Kontrollgruppe
|
Vectibix® (6mg/kg) combined with mFOLFOX6, Q2W |
|
Eksperimentell: Testgruppe
|
QL1203 (6mg/kg) combined with mFOLFOX6, Q2W |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
AUCtau, sd
Tidsramme: through the Cycle 1 (each cycle is 2 weeks)
|
Area under the serum concentration-time curve over one dosing interval after the first dose of QL1203 and Vectibix® |
through the Cycle 1 (each cycle is 2 weeks)
|
|
AUCtau,ss,
Tidsramme: through the Cycle 4 (each cycle is 2 weeks)
|
Area under the serum concentration-time curve over one dosing interval at steady state (at Cycle 4) |
through the Cycle 4 (each cycle is 2 weeks)
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- QL1203-103
Legemiddel- og utstyrsinformasjon, studiedokumenter
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