Colorectal Cancer MetastaticPhase 1NCT05674526

A Phase 1b Study of WU-NK-101 in Combination With Cetuximab

A Phase 1 study testing WU-NK-101 - Dose Escalation, Cetuximab - Dose Escalation and WU-NK-101 - Cohort Expansion in people with Colorectal Cancer Metastatic and Squamous Cell Carcinoma of Head and Neck, run by Allotera Therapeutics at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

This study is a Phase 1b open-label study designed to characterize the safety, tolerability, and preliminary anti-tumor activity of WU-NK-101 in combination with cetuximab in patients with advanced and/or metastatic CRC (Cohort 1), and in patients with advanced and/or metastatic SCCHN (Cohort 2). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Colorectal Cancer Metastatic, Squamous Cell Carcinoma of Head and Neck
What is being tested?: WU-NK-101 - Dose Escalation, Cetuximab - Dose Escalation and WU-NK-101 - Cohort Expansion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 2 sitesUnited States
Study dates: 21 May 2024to 1 Jun 2026
Phase: Phase 1
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

Patients must have a histologically confirmed diagnosis of advanced and/or metastatic CRC that has failed or progressed beyond first line or higher line standard of care therapy including bevacizumab combination, cetuximab combination, 5-FU based regimens, or checkpoint inhibitors alone or in combination. Patients must have received all targeted therapies for which they are eligible. Patients may be included in this study regardless of mutation status (e.g., RAS-mutant, wild-type, or unknown status, BRAF V600E, etc.) and EGFR expression.
Or,
Patients must have a histologically confirmed diagnosis of SCCHN that has failed or progressed beyond first or higher line standard of care therapy including cetuximab alone or in combination, checkpoint inhibitors alone and in combination, or regimens containing radiotherapy. Patients may be included in this study regardless of EGFR expression.

Who cannot join

Experienced toxicities related to prior cetuximab treatment which required permanent discontinuation of cetuximab per the current label.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

UCSF
San Francisco, California, 94143
Montefiore Medical Center
The Bronx, New York, 10467

Other trials in United States

About this study

Official title: A Phase 1b Study of WU-NK-101 in Combination With Cetuximab for Advanced and/or Metastatic Colorectal Cancer (CRC) and Advanced and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)

Read the detailed description

In the Dose Escalation Phase, up to 12 patients with either advanced and/or metastatic CRC or advanced and/or metastatic SCCHN will be treated with WU-NK-101, alone and in combination with cetuximab, in successive cohorts of 3 to 6 patients using a standard 3 + 3 design. Intra-patient dose escalation is not permitted. Patients may receive up to one 8-week cycle of treatment. Each 8-week cycle is divided into two 28-day segments, (Segments A and B).

During Segment A, only WU-NK-101 (monotherapy) will be administered. Segment A will consist of two doses of WU-NK-101 infused on Day 1 and Day 15. Patients that do not experience a dose limiting toxicity (DLT) will proceed to Segment B.

During Segment B, WU-NK-101 will be administered in combination with cetuximab (combination therapy). WU-NK-101 cells will be administered on Days 30 and 44. Cetuximab will be administered on Days 29 and 43 at 500 mg/m2 (FDA-approved dose).

Once the MTD/MAD is defined in the Dose Escalation Phase, up to 9 additional patients will be enrolled in 2 parallel, disease specific, expansion cohorts (Cohort 1 [patients with CRC] and Cohort 2 [patients with SCCHN]) to further characterize the safety, tolerability, and preliminary anti-tumor activity of WU-NK-101 cells in combination with cetuximab. Patients will receive cetuximab dosed at 500 mg/m2 on Days 1 and 15, and WU-NK-101 on Days 2 and 16, in each 4-week cycle.

At the end of Cycle 2, patients who achieve a partial response (PR) or stable disease (SD) may receive up to 4 additional cycles of treatment of WU-NK-101 cells in combination with cetuximab with disease assessments on Day 28 (+/- 3 days) of each even numbered cycle, for a maximum of 6 cycles.

Conditions: Colorectal Cancer Metastatic, Squamous Cell Carcinoma of Head and Neck
Being tested: WU-NK-101 - Dose Escalation, Cetuximab - Dose Escalation, WU-NK-101 - Cohort Expansion, Cetuximab - Cohort Expansion
Keywords: NK cells, allogeneic NK cells, cetuximab
Medical subject headings: Squamous Cell Carcinoma of Head and Neck

What participants receive

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

WU-NK-101 - Dose EscalationBiological
WU-NK-101 administered on Days 1, 15, 30 and 44
Cetuximab - Dose EscalationDrug
Cetuximab 500mg/m2 administered on Days 29 and 43
WU-NK-101 - Cohort ExpansionBiological
WU-NK-101 administered on Days 2 and 16
Cetuximab - Cohort ExpansionBiological
Cetuximab 500mg/m2 administered on Days 1 and 15

Study groups in NCT05674526
Study group	Role	What they receive
WU-NK-101 Monotherapy/Cetuximab combo Run-in	Experimental	WU-NK-101 is a non-engineered Natural Killer (NK) cell derived from peripheral blood mononuclear cells (PBMC) that is cytokine-reprogrammed, expanded, and cryopreserved to create an allogeneic enhanced memory-like anti-tumor NK cell therapy product. Each 8 week cycle in dose escalation is divided into two 28- days segments. Patients will receive WU-NK-101 (Days 1 and 15) in the first segment and a combination of cetuximab (500mg/m2 on Days 29 and 43) plus WU-NK-101 (Days 30 and 44) in the second segment. Receives: Biological: WU-NK-101 - Dose Escalation; Drug: Cetuximab - Dose Escalation
WU-NK-101 /Cetuximab Combo	Experimental	Patients will receive cetuximab dosed at 500 mg/m2 on Days 1 and 15, and WU-NK-101 on Days 2 and 16, in each 4-week cycle. Depending on response patients may receive up to 6 cycles of treatment. Receives: Biological: WU-NK-101 - Cohort Expansion; Biological: Cetuximab - Cohort Expansion

What is being measured

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

Incidence of Adverse Events of WU-NK-101 in combination with cetuximab as assessed by by CTCAE v5
Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of consent until the end of the study visit or at the end of treatment visit.
Measured: 24 months
Maximum Tolerated Dose
Maximum tolerated or administered dose of WU-NK-101 in combination with cetuximab
Measured: up to 56 days from first dose

Secondary outcomes (2)

Duration of Response
Time of response to the time of disease relapse, progression or death due to any cause
Measured: 24 months
Overall Response Rate
ORR is defined as the proportion of patients that achieve complete remission (CR) + partial response (PR) using modified Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1)
Measured: 24 months

Timeline

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

21 May 20241 Jun 2026

First posted6 Jan 2023
Study start21 May 2024
Primary completion30 Sep 2025 (estimated)
Study completion1 Jun 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Colorectal Cancer MetastaticStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: In dose expansion patients will be enrolled in 2 parallel, disease specific cohorts to further characterize the safety, tolerability and preliminary anti- tumor activity of WU-NK-101 in combination with cetuximab
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05674526
Sponsor's protocol ID: WUN101-02
Status last verified: Apr 2025
First submitted: 30 Dec 2022
Last updated: 15 Apr 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 1b Study of WU-NK-101 in Combination With Cetuximab for Advanced and/or Metastatic Colorectal Cancer (CRC) and Advanced and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
ClinicalTrials.gov ID: NCT05674526
Acronym / sponsor ID: WUN101-02
Conditions: Colorectal Cancer Metastatic, Squamous Cell Carcinoma of Head and Neck
Keywords: NK cells, allogeneic NK cells, cetuximab
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: Allotera TherapeuticsIndustry (pharma, biotech, devices)
Study start: 21 May 2024 (actual)
Primary completion: 30 Sep 2025 (estimated)
Study completion: 1 Jun 2026 (estimated)
First posted: 6 Jan 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: In dose expansion patients will be enrolled in 2 parallel, disease specific cohorts to further characterize the safety, tolerability and preliminary anti- tumor activity of WU-NK-101 in combination with cetuximab

Arm	Type	Receives
WU-NK-101 Monotherapy/Cetuximab combo Run-in	Experimental	Biological: WU-NK-101 - Dose Escalation, Drug: Cetuximab - Dose EscalationWU-NK-101 is a non-engineered Natural Killer (NK) cell derived from peripheral blood mononuclear cells (PBMC) that is cytokine-reprogrammed, expanded, and cryopreserved to create an allogeneic enhanced memory-like anti-tumor NK cell therapy product. Each 8 week cycle in dose escalation is divided into two 28- days segments. Patients will receive WU-NK-101 (Days 1 and 15) in the first segment and a combination of cetuximab (500mg/m2 on Days 29 and 43) plus WU-NK-101 (Days 30 and 44) in the second segment.
WU-NK-101 /Cetuximab Combo	Experimental	Biological: WU-NK-101 - Cohort Expansion, Biological: Cetuximab - Cohort ExpansionPatients will receive cetuximab dosed at 500 mg/m2 on Days 1 and 15, and WU-NK-101 on Days 2 and 16, in each 4-week cycle. Depending on response patients may receive up to 6 cycles of treatment.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients must have a histologically confirmed diagnosis of advanced and/or metastatic CRC that has failed or progressed beyond first line or higher line standard of care therapy including bevacizumab combination, cetuximab combination, 5-FU based regimens, or checkpoint inhibitors alone or in combination. Patients must have received all targeted therapies for which they are eligible. Patients may be included in this study regardless of mutation status (e.g., RAS-mutant, wild-type, or unknown status, BRAF V600E, etc.) and EGFR expression.
Or,
Patients must have a histologically confirmed diagnosis of SCCHN that has failed or progressed beyond first or higher line standard of care therapy including cetuximab alone or in combination, checkpoint inhibitors alone and in combination, or regimens containing radiotherapy. Patients may be included in this study regardless of EGFR expression.

Key exclusion criteria (1 listed)

Experienced toxicities related to prior cetuximab treatment which required permanent discontinuation of cetuximab per the current label.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
WU-NK-101 - Dose EscalationWU-NK-101 administered on Days 1, 15, 30 and 44	Biological	WU-NK-101 Monotherapy/Cetuximab combo Run-in
Cetuximab - Dose EscalationCetuximab 500mg/m2 administered on Days 29 and 43	Drug	WU-NK-101 Monotherapy/Cetuximab combo Run-in
WU-NK-101 - Cohort ExpansionWU-NK-101 administered on Days 2 and 16	Biological	WU-NK-101 /Cetuximab Combo
Cetuximab - Cohort ExpansionCetuximab 500mg/m2 administered on Days 1 and 15	Biological	WU-NK-101 /Cetuximab Combo

Primary outcome

Incidence of Adverse Events of WU-NK-101 in combination with cetuximab as assessed by by CTCAE v5
Time frame: 24 months
Safety is based on evaluation of adverse events (AEs) and serious adverse events (SAEs) from the time of consent until the end of the study visit or at the end of treatment visit.
Maximum Tolerated Dose
Time frame: up to 56 days from first dose
Maximum tolerated or administered dose of WU-NK-101 in combination with cetuximab

2 secondary outcomes

Duration of Response
Time frame: 24 months
Overall Response Rate
Time frame: 24 months

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cherry Thomas, MD study director

Allotera Therapeutics

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events of WU-NK-101 in combination with cetuximab as assessed by by CTCAE v5 (time frame: 24 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 NCT05674526.

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 15 Apr 2025.