Clinical Trial 23787

• Overview

  Study Title:

  A Phase 1/2, 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

  Summary:

  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.

  Objective:

  Primary Objectives: Phase 1a: - To evaluate the safety and tolerability of ALX2004 as a single agent in previously treated participants with known EGFR-expressing select advanced or metastatic solid tumors. - To determine the MTD at Q3W and Q2W and the recommended doses for expansion (RDEs) of ALX2004 as a single agent in previously treated participants with known EGFRexpressing select advanced or metastatic solid tumors. Phase 1b: - To further evaluate the preliminary response of ALX2004 as a single agent in previously treated participants with known EGFR-expressing select advanced or metastatic solid tumors. Secondary Objectives: Phase 1a: - To characterize the single and multiple-dose PK profiles of ALX2004 total antibody, total ADC, and TOP1 inhibitor payload. - To evaluate the immunogenicity of ALX2004. - To evaluate the preliminary anti-tumor activity of ALX2004 in previously treated participants with known EGFR-expressing select advanced or metastatic solid tumors. Phase 1b: - To further evaluate the preliminary additional anti-tumor activity of ALX2004 as a single agent in previously treated participants with known EGFR-expressing select advanced or metastatic solid tumors. - To further assess the overall safety and tolerability of ALX2004. - To further characterize the PK profiles of ALX2004. - To further evaluate the immunogenicity of ALX2004.

• Treatments

  Therapies:

  Antibody Drug Conjugate Targeting EGFR; Immunotherapy

  Medications:

  ALX2004 (); Pembrolizumab ()

• Inclusion Criteria

  Inclusion Criteria:
  • Participants with locally advanced, recurrent or metastatic histologically confirmed HNSCC, NSCLC, ESCC, CRC; locally advanced or recurrent disease must not be amenable to resection with curative intent
  • Dose Escalation: Participants who have relapsed or progressed following prior anticancer therapy in the advanced/metastatic setting and for whom no approved or standard therapy is available.
  • Dose Exploration and Dose Expansion: The following tumor-specific criteria also apply. These cohorts will include all or a subset of these tumors.
  • 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 participants 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 - 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.
  • Adequate Bone Marrow Function
  • Adequate Renal & Liver Function
  • Adequate Performance Status
  • Other criteria may apply

• Exclusion Criteria

  Key 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.
  • Additional criteria may apply.

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