A First in Human Study of ALX2004 With Advanced or Metastatic Selected Solid Tumors

ALX Oncology

Status and phase

Enrolling

Phase 1

Conditions

ESCC

CRC (Colorectal Cancer)

NSCLC (Advanced Non-small Cell Lung Cancer)

HNSCC

Colo-rectal Cancer

Esophageal Squamous Cell Carcinoma (ESCC)

Head and Neck Cancer

Treatments

Drug: ALX2004

Study type

Interventional

Funder types

Industry

Identifiers

NCT07085091

ALX2004-01

Details and patient eligibility

About

A Phase 1, First in Human, Open-Label Multicenter Study to Evaluate ALX2004, an Antibody Drug Conjugate Targeting EGFR in Participants with Advanced or Metastatic Select Solid Tumors

Full description

This study consists of Phase 1a Dose finding, comprising of Dose Escalation portion followed by Dose Exploration, and a Phase 1b Dose Expansion. The study will enroll previously treated advanced or metastatic non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), esophageal squamous cell carcinoma (ESCC) and colorectal cancer (CRC). Up to 170 patients are expected to be enrolled in the study.

Enrollment

170 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants with locally advanced, recurrent or metastatic disease; locally advanced or recurrent disease must not be amenable to resection with curative intent
Participants with the following histologically confirmed tumor types for:
1. Dose Escalation:
  
  HNSCC - Received no more than 3 prior lines of therapy in the advanced or metastatic setting NSCLC - For participants with a targetable molecular alteration: received appropriate standard targeted therapy and no more than 2 prior lines of systemic chemotherapy in the advanced/metastatic setting
  
  For patients without a targetable molecular alteration: received platinum-based chemotherapy and CPI (in combination or separately), and have received no more than 2 prior lines of systemic chemotherapy in the advanced/metastatic setting
  
  ESCC - Received no more than 3 prior lines of therapy in the advanced/metastatic setting CRC (left-sided) - For participants with a targetable molecular alteration (including dMMR or MSI-H): Received appropriate standard therapy for the alteration, at least 2 prior lines of systemic chemotherapy, and no more than 4 prior lines of therapy in the advanced/metastatic setting For participants without a targetable molecule alteration: Received at least 2 prior lines of systemic chemotherapy (including an oxaliplatin-based chemotherapy), vascular endothelial growth factor (VEGF)-based therapy, and no more than 4 prior lines of therapy in the advanced/metastatic setting.
2. Dose Exploration: All or a subset of tumors tested in Dose Escalation
3. Dose Expansion: Subset of tumors tested in Dose Escalation
Adequate Bone Marrow Function
Adequate Renal & Liver Function
Adequate Performance Status

Exclusion criteria

Participants with disease suitable for local therapy with curative intent.
Has a life expectancy of less than 3 months and/or has rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator
Prior treatment with any ADCs that have an active TOP1 inhibitor-based component

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

170 participants in 3 patient groups

ALX2004 Phase 1a (Dose Escalation)

Experimental group

Description:

ALX2004 will be administered. Patients will be enrolled into escalating dose levels during the dose escalation phase

Treatment:

Drug: ALX2004

ALX2004 Phase 1a (Dose Exploration)

Experimental group

Description:

ALX2004 will be administered. All or a subset of tumors tested in dose escalation will enroll into 1 or 2 dose levels during the dose exploration phase

Treatment:

Drug: ALX2004

ALX2004 Phase 1b (Dose Expansion)

Experimental group

Description:

ALX2004 will be administered. Patients will receive the recommended phase 2 dose during the dose expansion phase

Treatment:

Drug: ALX2004