RECRUITING

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

Description

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

Conditions

NSCLC (Advanced Non-small Cell Lung Cancer)HNSCCCRC (Colorectal Cancer)ESCCColo-rectal CancerHead and Neck CancerEsophageal Squamous Cell Carcinoma (ESCC)
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Related Conditions:

NSCLC (Advanced Non-small Cell Lung Cancer)HNSCCCRC (Colorectal Cancer)ESCCColo-rectal CancerHead and Neck CancerEsophageal Squamous Cell Carcinoma (ESCC)

Study Overview

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Study Details

Study overview

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

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

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

Condition
NSCLC (Advanced Non-small Cell Lung Cancer)
Intervention / Treatment

-

Contacts and Locations

Fairfax

NEXT Oncology, Fairfax, Virginia, United States, 22031

Spokane

Summit Cancer Center, Spokane, Washington, United States, 99208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

ALX Oncology Inc.,

Study Record Dates

2027-12