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Closed (no longer recruiting)Last updated: 1 March 2024

M20-111: This Phase I trial is evaluating how safe and tolerable a new cancer drug (ABBV-637) is alone, or in combination with chemotherapy (docetaxel) or targeted therapy (osimertinib) in in people with relapsed or refractory solid cancersA Phase 1 First In Human Study Evaluating Safety And Efficacy Of ABBV-637 As Either Monotherapy Or In Combination In Adult Subjects With Relapsed And Refractory Solid Tumors

Clinical summary


This is a non-randomised, sequential assignment trial with two parts. The purpose of this study is to evaluate the safety and efficacy (how well the study drug works against the disease) of ABBV-637 alone or in combination with docetaxel/osimertinib in participants with solid tumours (NSCLC). People with relapsed or refractory solid cancers are eligible for Part 1. To participate in Part 2, participants must have non-small cell lunch cancer (NSCLC). In Part 1, participants with solid tumours will receive intravenous (IV) ABBV-637 in 28-day cycles. In Part 2a and 2b, participants will receive IV ABBV-637 in combination with IV docetaxel in 28-day cycles. In Part 3a and 3b, participants will receive intravenous (IV) ABBV-637 in combination with daily oral tablets of osimertinib in 28 days cycle.


This trial is treating patients with solid cancers and non-small cell lung cancer.


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Scientific Title

A Phase 1 First In Human Study Evaluating Safety And Efficacy Of ABBV-637 As Either Monotherapy Or In Combination In Adult Subjects With Relapsed And Refractory Solid Tumors



  • Histologic solid tumor diagnosis (Part 1).
  • For Part 2 docetaxel combination therapy: EGFR WT expressing relapsed/refractory (R/R) non-small cell lung cancer (NSCLC) participants.
  • For Part 3 osimertinib combination therapy: mutEGFR-expressing RR NSCLC participants.
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
  • For Part 1 only - history of R/R disease that has progressed on all standard of care therapy.
  • For Part 2 only - history of RR NSCLC that has progressed after treatment with platinum-based chemotherapy regimen and either immune checkpoint inhibitor or targeted therapy and may not have been treated with prior single agent chemotherapy.
  • For Part 3 only - history of RR NSCLC that has progressed on osimertinib
  • Meet the laboratory values as described in the protocol.


  • History (within 6 months) of congestive heart failure (defined as New York Heart Association, Class 2 or higher), ischemic cardiovascular event, cardiac arrhythmia requiring pharmacological or surgical intervention, pericardial effusion, or pericarditis.
  • Unresolved Grade 2 or higher toxicities related to previous anticancer therapy except alopecia.
  • For Part 3 only: History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, nor any evidence of active ILD or pneumonitis.


  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.


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

Clinical trials have complex eligibility criteria.

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