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 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
960
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Genmab Trial Information
- Telefonnummer: +4570202728
- E-mail: clinicaltrials@genmab.com
Studiesteder
-
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Georgia
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Savannah, Georgia, Forenede Stater, 31405
- Rekruttering
- Low Country Cancer Care Associates_Savannah_1
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Warner Robins, Georgia, Forenede Stater, 31088
- Rekruttering
- Central Georgia Cancer Care - Warner Robins Office
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46260
- Rekruttering
- Hematology-Oncology of Indiana, P.C.
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Missouri
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Springfield, Missouri, Forenede Stater, 65807
- Rekruttering
- Oncology Hematology Associates - Springfield_Springfield_2
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Washington
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Olympia, Washington, Forenede 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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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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).
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Fluorouracil + leucovorin (calcium folinate) + irinotecan via intravenous infusion.
Fluorouracil + leucovorin (calcium folinate) + oxaliplatin via intravenous infusion.
Intravenous infusion
|
Hvad måler undersøgelsen?
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
|
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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
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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
|
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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
|
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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
|
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Time to Worsening in Symptoms and Functioning, as Measured by EORTC QLQ-CR29
Tidsramme: Up to approximately 62 months
|
Up to approximately 62 months
|
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Overall Side Effect Burden, as Measured by EORTC Item 168
Tidsramme: Up to approximately 62 months
|
Up to approximately 62 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Study Official, Genmab
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
11. august 2026
Primær færdiggørelse (Anslået)
1. juli 2029
Studieafslutning (Anslået)
1. september 2031
Datoer for studieregistrering
Først indsendt
9. juli 2026
Først indsendt, der opfyldte QC-kriterier
9. juli 2026
Først opslået (Faktiske)
14. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. september 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. september 2026
Sidst verificeret
1. september 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- GCT1158-08
- 2026-525883-17 (Anden identifikator: EU CT Number)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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