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A Phase 1 first in human study evaluating safety, pharmacokinetics and efficacy of ABBV-400 in adult subjects with advanced solid tumors

Study to Assess Adverse Events and Change in Disease Activity in Adult Participants with Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400

Yamagishi Chika

AbbVie G.K.

3-1-21 Shibaura, Minato-ku, Tokyo

AbbVie_JPN_info_clingov@abbvie.com

Medical Informarion

AbbVie G.K.

3-1-21 Shibaura, Minato-ku, Tokyo

+81-120-587-874

AbbVie_JPN_info_clingov@abbvie.com

Not Recruiting

Nov. 15, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

- 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.
-For Part 6 only - Participants with advanced histologically or cytologically confirmed solid tumors harboring MET mutations including: mutations in the tyrosine kinase domain, the juxtamembrane region and the extracellular domain (as locally determined by next-generation sequencing (NGS) or a validated qPCR on tissue), 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.
-Intolerant to the standard treatment are eligible
For Part 7 (CRC combination) only: Participants with history of advanced histopathologically or cytologically confirmed CRC that does not harbor the mutation and are not dMMR+/MSI-H 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. Participants treated previously with TAS-102 or regorafenib are not eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Laboratory values meeting the criteria outlined in the protocol.

- 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.
- For Part 7 only: Prior TAS-102 or regorafenib treated participants are not eligible.

Both

Non-small cell lung cancer, Advanced Solid Tumors, Gastroesophageal Adenocarcinoma,Colorectal Cancer

- Part 1 (Monotherapy Dose Escalation): Participants with advanced solid tumors will receive escalating doses of ABBV-400. (Intravenous (IV) Infusion)
- Part 2i (wtEGFR NSCLC): Participants with non-squamous wtEGFR NSCLC will receive ABBV-400 at the Recommended Phase 2 dose (RP2D). (Intravenous (IV) Infusion)
- Part 2ii (mutEGFR NSCLC): Participants with non-Squamous mutEGFR NSCLC will receive ABBV-400 at RP2D. (Intravenous (IV) Infusion)
- Part 2iii (Squamous NSCLC): Participants with squamous NSCLC will receive ABBV-400 at RP2D. (Intravenous (IV) Infusion)
- Part 3 (Gastroesophageal Adenocarcinoma/Gastroesophagel Junction Adenocarcinoma): Participants with gastroesophageal adenocarcinoma will receive ABBV-400 at the RP2D. (Intravenous (IV) Infusion)
- Part 4 (Colorectal Cancer): Participants with Colorectal Cancer will receive ABBV-400 at the RP2D and various dose levels for dose optimization. (Intravenous (IV) Infusion)
- Part 5 (MET Amplification): Participants with mesenchymal-epithelial transition proto-oncogene (MET) amplification will receive ABBV-400 at the RP2D and various dose levels for dose optimization. (Intravenous (IV) Infusion)
- Part 6 (MET Mutation): Participants with MET mutation will receive ABBV-400 at the RP2D and various dose levels for dose optimization. (Intravenous (IV) Infusion)
- Part 7a (Combination Dose Escalation): Participants with CRC will receive escalating doses of ABBV-400 in combination with bevacizumab.
- Part 7bi (Combination Dose Optimization Low Dose): Participants with CRC will receive the low dose determined in the dose escalation arm (Part 7a) of ABBV-400 in combination with bevacizumab.
- Part 7bii (Combination Dose Optimization High Dose): Participants with CRC will receive the high dose determined in the dose escalation arm (Part 7a) of ABBV-400 in combination with bevacizumab.
- Part 7biii (Combination Comparator): Participants with CRC will receive trifluridine/tipiracil (TAS-102) in combination with bevacizumab.

- Objective Response Rate (ORR) [ Time Frame: Up to Month 24 ]
ORR defined as percentage of participants with confirmed best overall response of Confirmed complete response (CR) and partial response (PR) per investigator review according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.

- Duration of Response (DOR) [ Time Frame: Up to 24 Months ]
DOR is defined for participants achieving a confirmed CR+PR as the time from the initial response of CR+PR per investigator review according to RECIST 1.1 criteria to disease progression or death of any cause, whichever occurs earlier.
- Overall survival (OS) [ Time Frame: Up to 24 Months ]
Overall survival (OS) is defined as time from first study treatment to death due to any cause.
- Progression free survival (PFS) [ Time Frame: Up to 24 Months ]
Progression-free survival (PFS) is defined as time from first study treatment to a documented disease progression according to RECIST version 1.1, as determined by the investigator, or death due to any cause, whichever occurs earlier.

+81-3-3542-2511

Oct. 29, 2021

No

United states/Puerto Rico/France/Israel/Korea/Taiwan/Spain/Australia/Poland