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Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400
About
Brief Summary
Cancer is a condition where cells in a specific part of body grow and reproduce uncontrollably. The purpose of this study is to assess adverse events and change in disease activity when ABBV-400 is given to adult participants to treat advanced solid tumors.
ABBV-400 is an investigational drug being developed for the treatment of advanced solid tumors. Study doctors put the participants in groups called treatment arms. The Recommended Phase 2 dose (RP2D) will be explored. Each treatment arm receives a different dose of ABBV-400. This study will include a dose escalation phase to determine the best dose of ABBV-400, followed by a dose expansion phase to confirm the dose. Approximately 460 adult participants with NSCLC, gastroesophageal adenocarcinoma/gastroesophagel junction adenocarcinoma (GEA) and colorectal cancer (CRC) or advanced solid tumors, will be enrolled in the study in approximately 7-10 sites in the Dose Escalation phase and 85-95 sites in the Dose Expansion phase worldwide. In the dose expansion arms, participants in the following advanced solid tumor indications: non-squamous NSCLC with wildtype EGFR-expression (wtEGFR NSCLC) (Part 2i) or mutated EGFR-expression (mutEGFR NSCLC) (Part 2ii), squamous NSCLC (Part 2iii), GEA [Part 3] will receive intravenous (IV) ABBV-400 monotherapy, participants CRC will receive intravenous (IV) ABBV-400 monotherapy in expansion [Part 4], and participants MET amplification will receive intravenous (IV) ABBV-400 monotherapy in expansion [Part 5]. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
Primary Purpose
Study Type
Phase
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
- 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 Criteria:
- 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.
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Study Stats
Protocol No.
22-002004
Category
Bladder Cancer
Colorectal Cancer
Esophageal Cancer
Head and Neck Cancer
Kidney Cancer
Liver Cancer
Lung Cancer
Melanoma (Skin Cancer)
Other Cancer
Ovarian Cancer
Pancreatic Cancer
Principal Investigator
Contact
Location
- UCLA Santa Monica
- UCLA Westwood