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

Phase 1Active Not RecruitingNCT05674526

Wugen, Inc.30 enrolled

Overview

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). The overall study will be comprised of two phases, a Dose Escalation Phase, and a Cohort Expansion Phase.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer Metastatic Squamous Cell Carcinoma of Head and Neck

Interventions

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

UCSF

San Francisco, California, United States

Montefiore Medical Center

The Bronx, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: 24 months

Maximum Tolerated Dose

Maximum tolerated or administered dose of WU-NK-101 in combination with cetuximab

Time frame: up to 56 days from first dose

Secondary Outcomes

Duration of Response

Time of response to the time of disease relapse, progression or death due to any cause

Time frame: 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)

Time frame: 24 months

Data from ClinicalTrials.gov

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