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Left-sided Colorectal CancerPhase 3NCT07702032

Study of Petosemtamab Plus Chemotherapy Versus Cetuximab Plus Chemotherapy in RAS and BRAF Wild-type, Unresectable or Metastatic, Left-sided Colorectal Cancer (LiGeR-CRC1)

A Phase 3 study testing Petosemtamab, Cetuximab and FOLFIRI in people with Left-sided Colorectal Cancer, run by Genmab at 12 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Left-sided Colorectal Cancer
What is being tested?
Petosemtamab, Cetuximab and FOLFIRI
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
960 participants
Where
12 sitesin 3 countries
Study dates
11 Aug 2026to Sep 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

12 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

Genmab Trial Information contact

+4570202728

clinicaltrials@genmab.com

12 sites in 3 countries

United States9 sites, 9 recruiting

  • New York Cancer and Blood Specialists - Babylon Medical Oncology

    Babylon, New York, 11702

    Recruiting

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

    Recruiting

  • Hematology-Oncology of Indiana, P.C.

    Indianapolis, Indiana, 46260

    Recruiting

  • Valkyrie Clinical Trials - Los Angeles

    Los Angeles, California, 90067

    Recruiting

  • Vista Oncology

    Olympia, Washington, 98502

    Recruiting

  • Low Country Cancer Care Associates_Savannah_1

    Savannah, Georgia, 31405

    Recruiting

  • Oncology Hematology Associates - Springfield_Springfield_2

    Springfield, Missouri, 65807

    Recruiting

  • Washington University Saint Louis

    St Louis, Missouri, 63110

    Recruiting

  • Central Georgia Cancer Care - Warner Robins Office

    Warner Robins, Georgia, 31088

    Recruiting

Other trials in United States

Australia2 sites, 2 recruiting

  • GenesisCare - St Andrew's ADELAIDE

    Adelaide, South Australia, 5000

    Recruiting

  • GenesisCare - Campbelltown CAMPBELLTOWN

    Campbelltown, New South Wales, 2560

    Recruiting

Other trials in Australia

Puerto Rico1 site, 1 recruiting

  • PanOncology

    Manati, PR, 00674

    Recruiting

Other trials in Puerto Rico

About this study

Official title: 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.

Read more

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.

Read the detailed description

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.

Being tested
Petosemtamab, Cetuximab, FOLFIRI, mFOLFOX6

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PetosemtamabDrug

    Intravenous infusion

  • CetuximabDrug

    Intravenous infusion

  • FOLFIRIDrug

    Fluorouracil + leucovorin (calcium folinate) + irinotecan via intravenous infusion.

  • mFOLFOX6Drug

    Fluorouracil + leucovorin (calcium folinate) + oxaliplatin via intravenous infusion.

Study groups in NCT07702032
Study groupRoleWhat they receive
Petosemtamab + IC ChemotherapyExperimentalParticipants will receive petosemtamab and IC chemotherapy (mFOLFOX6 or FOLFIRI).
Receives: Drug: Petosemtamab; Drug: FOLFIRI; Drug: mFOLFOX6
Cetuximab + IC ChemotherapyActive comparatorParticipants will receive cetuximab + IC chemotherapy (mFOLFOX6 or FOLFIRI).
Receives: Drug: Cetuximab; Drug: FOLFIRI; Drug: mFOLFOX6

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Central Review (BICR)

    Measured: Up to approximately 35 months

  2. Objective Response Rate (ORR) per RECIST v1.1 as Assessed by BICR

    Measured: Up to approximately 35 months

Secondary outcomes (11)

  1. Overall Survival (OS)

    Measured: Up to approximately 62 months

  2. Duration of Response (DOR) per RECIST v1.1 as Assessed by BICR

    Measured: Up to approximately 62 months

  3. Disease Control Rate (DCR) per RECIST v1.1 as Assessed by BICR

    Measured: Up to approximately 62 months

  4. Progression-free Survival after First Subsequent Therapy (PFS2)

    Measured: Up to approximately 62 months

  5. Curative Resection (R0) Rate

    Measured: Up to approximately 62 months

  6. Number of Participants with Adverse Events (AEs)

    Measured: Up to approximately 62 months

  7. 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

    Measured: Baseline up to approximately 62 months

  8. Change from Baseline in Symptoms and Functioning, as Measured by EORTC QLQ-CR29

    Measured: Baseline up to approximately 62 months

  9. Time to Worsening in Symptoms and Functioning, as Measured by EORTC QLQ-F17

    Measured: Up to approximately 62 months

  10. Time to Worsening in Symptoms and Functioning, as Measured by EORTC QLQ-CR29

    Measured: Up to approximately 62 months

  11. Overall Side Effect Burden, as Measured by EORTC Item 168

    Measured: Up to approximately 62 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2026
  2. Study start11 Aug 2026
  3. Primary completionJul 2029 (estimated)
  4. Study completionSep 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
960 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07702032
Sponsor's protocol ID
GCT1158-08
Other IDs
2026-525883-17
Status last verified
Nov 2026
First submitted
9 Jul 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Petosemtamab, Cetuximab and FOLFIRI in people with Left-sided Colorectal Cancer, run by Genmab at 12 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, Australia, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Genmab Trial Information (+4570202728, clinicaltrials@genmab.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free Survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as Assessed by Blinded Independent Central Review (BICR) (time frame: Up to approximately 35 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07702032.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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