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Outcome Measures

Primary Outcomes (2)

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.
24 months
Maximum Tolerated Dose
Maximum tolerated or administered dose of WU-NK-101 in combination with cetuximab
up to 56 days from first dose

Secondary Outcomes (2)

Duration of Response
24 months
Overall Response Rate
24 months

Study Arms (2)

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.

Biological: WU-NK-101 - Dose EscalationDrug: 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.

Biological: WU-NK-101 - Cohort Expansion

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Administration procedure

Cetuximab - Dose Escalation

The registry describes an administration procedure or treatment schedule. Actual exposure and doses are not established by this entry.

View registry record

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Study Design

Study Type

interventional

Phase

phase 1

Allocation

NON RANDOMIZED

Masking

NONE

Purpose

TREATMENT

Intervention Model

PARALLEL

Model Details: 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

Sponsor Type

INDUSTRY

Responsible Party

SPONSOR

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

WU-NK-101 Monotherapy/Cetuximab combo Run-in

WU-NK-101 /Cetuximab Combo

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (2)

Study Arms (2)

WU-NK-101 Monotherapy/Cetuximab combo Run-in

WU-NK-101 /Cetuximab Combo

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations