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Recruitment on holdLast updated: 3 May 2024

M21-404: This study is evaluating how safe and effective a new, investigational drug (called ABBV-400) is when given to adult participants to treat advanced solid cancersA Phase 1 First in Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-400 in Adult Subjects With Advanced Solid Tumors

Clinical summary

Summary

This study will include a dose escalation phase to determine the best dose of the investigational drug ABBV-400, followed by a dose expansion phase to confirm the dose.

In the Dose Escalation phase, participants with advanced solid cancers will receive escalating doses of ABBV-400 which will be administered as an intravenous infusion.

In the Dose Expanion phase, participants will be allocated to different cohorts according to their cancer type:

  • Part 2i - wtEGFR non-small cell lung cancer
  • Part 2ii - mutEGFR non-small cell lung cancer
  • Part 2iii - squamous non-small cell lung cancer
  • Part 3 - Gastro-oesophageal adenocarcinoma / gastro-oesophageal junction adenocarcinoma
  • Part 4 - colorectal cancer
  • Part 5 - advanced solid cancers characterised by MET amplification

Participants will receive ABBV-400 via intravenous infusion at the Recommended Phase 2 Dose (RP2D). Parts 4 and 5 cohorts will receive the RP2D and various dose levels for dose optimisation.

Conditions

This trial is treating patients with non-small cell lung cancer, gastro-oesophageal and gastro-oesophageal junction cancer, colorectal cancer, and advanced solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

Trial Acronym

M21-404

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

NCT05029882

Scientific Title

A Phase 1 First in Human Study Evaluating Safety, Pharmacokinetics and Efficacy of ABBV-400 in Adult Subjects With Advanced Solid Tumors

Eligibility

Inclusion

  • Histologic malignant solid tumor diagnosis (World Health Organization [WHO] criteria).
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • For Part 1 only - history of advanced solid tumor that has progressed on all standard of care therapy and are not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
  • For Part 2 only - history of advanced non-squamous wtEGFR or mutEGFR or history of advanced squamous Non-Small Cell Lung Cancer (NSCLC) that have progressed after treatment with at least:

    • Platinum-based chemotherapy and an immune checkpoint inhibitor and/or appropriate targeted therapy for an actionable gene alteration, if applicable, for non-squamous wtEGFR and squamous NSCLC (Parts 2i and 2iii).
    • Platinum-based chemotherapy doublet and tyrosine kinase inhibitor(s) (TKI[s]) for non- squamous mutEGFR NSCLC (Part 2ii).
    • Should have no more than 2 lines of prior cytotoxic chemotherapy excluding adjuvant therapy and must have advanced NSCLC that is not amenable to surgical resection or other approved therapeutic options that have demonstrated clinical benefit.
  • For Part 3 only - history of advanced histopathologically or cytologically confirmed diagnosis of gastroesophageal adenocarcinoma/gastroesophagel junction adenocarcinoma (GEA) that has progressed after treatment with at least 1 prior cytotoxic chemotherapeutic regimen for locally advanced or metastatic disease and have not received more than 2 prior lines of cytotoxic chemotherapy regimens. Participants must have progressed on

    • If applicable, an immune checkpoint inhibitor.
    • If applicable, appropriate available therapies, including HER2-directed therapies.
  • For Part 4 only - Participants with history of advanced histopathologically or cytologically confirmed colorectal cancer (CRC) that does not harbor the BRAF V600E mutation and are not dMMR+/MSI-Hi with progression on:

    • A fluoropyrimidine (e.g., 5-fluorouracil or capecitabine).
    • Oxaliplatin.
    • Irinotecan.
    • If applicable, anti-EGFR (including, but not limited to cetuximab or panitumumab).
    • If applicable, anti-vascular endothelial growth factor (VEGF) monoclonal antibody (including but not limited to bevacizumab, ramucirumab, or aflibercept).
    • If applicable, targeted therapy
    • Participants who are considered ineligible for or are intolerant of standard therapy per investigator are eligible. Prior treatment with Lonsurf or Regorafenib is also acceptable.
  • For Part 5 only - participants with advanced histologically or cytologically confirmed solid tumors characterized by MET amplification who are not amenable to surgical resection and who have disease progression after at least one prior systemic therapy and/or who have no satisfactory alternative treatment options. Participants who are intolerant to standard treatment are eligible.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • Laboratory values meeting the criteria outlined in the protocol.

Exclusion

  • History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis.
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.
  • History of clinically significant, intercurrent lung-specific illnesses, as noted in the protocol.

Inclusion

  • Your cancer has not spread to other parts of the body.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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