Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer (LiGeR-CRC1)
8. september 2026 oppdatert av: Genmab
A Randomized, Open-label, Phase 3 Trial of Petosemtamab in Combination With mFOLFOX6 or FOLFIRI Versus Cetuximab in Combination With mFOLFOX6 or FOLFIRI as First-line Treatment for Participants With RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer
The purpose of this trial is to evaluate how well petosemtamab in combination with chemotherapy works against colorectal cancer located on the left side of the colon that cannot be safely removed by surgery or has spread to other parts of the body.
Participants will receive either petosemtamab + doctor's choice of chemotherapy (mFOLFOX6 or FOLFIRI) or standard-of-care cetuximab + doctor's choice of chemotherapy (mFOLFOX6 or FOLFIRI). No participants will be given placebo.
The treatment duration will be different for every participant. If a participant's cancer stays the same or gets better, and there are not any serious problems, participants can keep getting study treatment for as long as the study is open.
Participants will be asked to attend 2 visits at the study clinic for each cycle (duration of cycle is 4 weeks). During visits, there will be various tests (such as blood draws) and procedures (such as imaging) to monitor whether the study treatment is safe and effective. The overall study duration (including screening, treatment, and follow-up) will be different for every participant.
Studieoversikt
Status
Rekruttering
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This Phase 3, randomized, open-label, global trial is designed to assess the efficacy and safety of petosemtamab plus investigator's choice (IC) chemotherapy (fluorouracil + leucovorin (calcium folinate) + oxaliplatin [mFOLFOX6] or fluorouracil + leucovorin (calcium folinate) + irinotecan [FOLFIRI]) versus standard of care (SOC) (ie, cetuximab + IC chemotherapy [mFOLFOX6 or FOLFIRI]) as 1L therapy in participants with unresectable or metastatic left-sided colorectal cancer.
Studietype
Intervensjonell
Registrering (Antatt)
960
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Genmab Trial Information
- Telefonnummer: +4570202728
- E-post: clinicaltrials@genmab.com
Studiesteder
-
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Georgia
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Savannah, Georgia, Forente stater, 31405
- Rekruttering
- Low Country Cancer Care Associates_Savannah_1
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Warner Robins, Georgia, Forente stater, 31088
- Rekruttering
- Central Georgia Cancer Care - Warner Robins Office
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Indiana
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Indianapolis, Indiana, Forente stater, 46260
- Rekruttering
- Hematology-Oncology of Indiana, P.C.
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Missouri
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Springfield, Missouri, Forente stater, 65807
- Rekruttering
- Oncology Hematology Associates - Springfield_Springfield_2
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Washington
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Olympia, Washington, Forente stater, 98502
- Rekruttering
- Vista Oncology
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PR
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Manati, PR, Puerto Rico, 00674
- Rekruttering
- PanOncology
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-
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
Key Inclusion Criteria:
- Histologically or cytologically confirmed left-sided colorectal adenocarcinoma that is unresectable or metastatic.
- Must have documented KRAS and NRAS wild type (wt) colorectal cancer (CRC), as determined by medical record of results from local testing or as assessed by central testing. Local testing must have been conducted in accordance with local guidelines using an Food and Drug Administration (FDA)-approved test or a laboratory-developed test that is validated in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory (sites in the United States) or an accredited local laboratory (sites outside of the United States). Next-generation sequencing (NGS)-based test results from tumor tissue are required for determining eligibility. Polymerase chain reaction (PCR)-based tests, sanger sequencing, or pyrosequencing test results are not allowed.
- Has not received any prior systemic therapy for unresectable or metastatic CRC.
- Must be eligible for treatment with mFOLFOX6 (if assigned to receive mFOLFOX6) or FOLFIRI (if assigned to receive FOLFIRI) according to local regulatory approvals and SOC guidelines.
Key Exclusion Criteria:
- BRAF mutation, and/or microsatellite instability-high (MSI-H)/deficient mismatch repair (dMMR) and/or protocol specified tumor status as documented by local test results in the medical record or from central testing or known documented activating HRAS mutation identified prior to enrollment from local testing results in the medical record, if available.
- Prior exposure to any agents that target epidermal growth factor receptor (EGFR) (including but not limited to protein products, monoclonal antibodies, tyrosine kinase inhibitors, or antisense oligonucleotide therapy).
- Known complete dihydropyrimidine dehydrogenase (DPD) deficiency or known homozygous/compound heterozygous dihydropyrimidine dehydrogenase gene (DPYD) variants associated with complete loss of DPD activity. Testing for DPD deficiency should be performed per local guidelines.
- For a participant who is to receive FOLFIRI: known to be homozygous for the UGT1A1*28 or *6 alleles or compound or double heterozygous for the UGT1A1*28 and *6 alleles. Testing for UGT1A1 should be done in accordance with local guidelines.
- Participants with non-colorectal adenocarcinomatous disease.
Note: Other protocol-defined Inclusion and Exclusion criteria may apply.
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: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Petosemtamab + IC Chemotherapy
Participants will receive petosemtamab and IC chemotherapy (mFOLFOX6 or FOLFIRI).
|
Intravenous infusion
Fluorouracil + leucovorin (calcium folinate) + irinotecan via intravenous infusion.
Fluorouracil + leucovorin (calcium folinate) + oxaliplatin via intravenous infusion.
|
|
Aktiv komparator: Cetuximab + IC Chemotherapy
Participants will receive cetuximab + IC chemotherapy (mFOLFOX6 or FOLFIRI).
|
Fluorouracil + leucovorin (calcium folinate) + irinotecan via intravenous infusion.
Fluorouracil + leucovorin (calcium folinate) + oxaliplatin via intravenous infusion.
Intravenous infusion
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Central Review (BICR)
Tidsramme: Up to approximately 35 months
|
Up to approximately 35 months
|
|
Objective Response Rate (ORR) per RECIST v1.1 as Assessed by BICR
Tidsramme: Up to approximately 35 months
|
Up to approximately 35 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Overall Survival (OS)
Tidsramme: Up to approximately 62 months
|
Up to approximately 62 months
|
|
Duration of Response (DOR) per RECIST v1.1 as Assessed by BICR
Tidsramme: Up to approximately 62 months
|
Up to approximately 62 months
|
|
Disease Control Rate (DCR) per RECIST v1.1 as Assessed by BICR
Tidsramme: Up to approximately 62 months
|
Up to approximately 62 months
|
|
Progression-free Survival after First Subsequent Therapy (PFS2)
Tidsramme: Up to approximately 62 months
|
Up to approximately 62 months
|
|
Curative Resection (R0) Rate
Tidsramme: Up to approximately 62 months
|
Up to approximately 62 months
|
|
Number of Participants with Adverse Events (AEs)
Tidsramme: Up to approximately 62 months
|
Up to approximately 62 months
|
|
Change from Baseline in Symptoms and Functioning, as Measured by European Organisation for Research and Treatment of Cancer (EORTC) Quality-of-life Questionnaire (QLQ)-F17
Tidsramme: Baseline up to approximately 62 months
|
Baseline up to approximately 62 months
|
|
Change from Baseline in Symptoms and Functioning, as Measured by EORTC QLQ-CR29
Tidsramme: Baseline up to approximately 62 months
|
Baseline up to approximately 62 months
|
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Time to Worsening in Symptoms and Functioning, as Measured by EORTC QLQ-F17
Tidsramme: Up to approximately 62 months
|
Up to approximately 62 months
|
|
Time to Worsening in Symptoms and Functioning, as Measured by EORTC QLQ-CR29
Tidsramme: Up to approximately 62 months
|
Up to approximately 62 months
|
|
Overall Side Effect Burden, as Measured by EORTC Item 168
Tidsramme: Up to approximately 62 months
|
Up to approximately 62 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Study Official, Genmab
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 (Faktiske)
11. august 2026
Primær fullføring (Antatt)
1. juli 2029
Studiet fullført (Antatt)
1. september 2031
Datoer for studieregistrering
Først innsendt
9. juli 2026
Først innsendt som oppfylte QC-kriteriene
9. juli 2026
Først lagt ut (Faktiske)
14. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- GCT1158-08
- 2026-525883-17 (Annen identifikator: EU CT Number)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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