A Phase I/II First-in-Human, Open-Label, Dose Escalation and Expansion Trial of TAK-505 Monotherapy in Participants with Unresectable Locally Advanced or Metastatic Solid Tumors
Study Description
Solid tumors occur when cells in an organ or tissue (for example in the lung or liver) start growing out of control (cancer) and form a lump or mass of cells. These solid cancers may grow very far in the general area where they started (called locally advanced) or may spread to other parts of the body (called metastatic), and doctors may not always be able to completely remove them with surgery (called unresectable).
This study is a first in human (or FIH) study, which means that this is the first time that the medicine, TAK-505, is given to a smaller group of adults with solid tumors of certain cancer types, such as stomach cancer (gastric adenocarcinoma), cancer of the large bowel (colorectal cancer or CRC), lung cancer (non-small lung cell cancer or NSCLC) and cancer in the mouth, throat or voice box (head and neck squamous cell carcinoma or HNSCC).
The main aims of this study are to learn how safe TAK-505 is, how well it works, how well adults with solid tumors tolerate it and to find the dose of TAK-505 that works best with the least side effects. Other aims are to learn how TAK-505 moves through the body (pharmacokinetics (PK)), if it can shrink or slow cancer (preliminary antitumor activity) and to find out if it causes the body's defense system to react to it (immunogenicity).
Eligibility
Inclusion Criteria:
-Aged greater than or equal to 18 years or age
-Criteria for disease state in dose escalation and cohort-expansion:
-Tumor histologies during dose escalation (including potential participants in backfill cohort): Participants with histologically or pathologically confirmed locally advanced or metastatic solid tumors, who are either ineligible for or intolerant of standard therapies, have no approved therapy with demonstrated benefit available, or have exhausted all available standard therapies: Gastric adenocarcinoma., Colorectal cancer (CRC)., Non-small cell lung cancer (NSCLC) (both squamous and non-squamous)., Head and neck squamous cell carcinoma (HNSCC). b) Tumor histologies during dose expansion: Participants will be eligible if they have histologically or pathologically confirmed, locally advanced or metastatic solid tumors, as follows:
-Metastatic or advanced squamous or non-squamous NSCLC:
-Participants with no known activating mutations: have received platinum-based chemotherapy and anti-programmed death protein 1 (PD-1)/programmed death ligand 1 (PD-L1) for locally advanced or metastatic disease (chemotherapy and anti-PD-1/PD-L1 -treatment can be received in combination or in sequence).
-Participants with a known activating mutation with an approved and accessible target therapy (including but not limited to epidermal growth factor receptor [EGFR], anaplastic lymphoma kinase, ROS proto-oncogene 1, receptor tyrosine kinase, v-raf murine sarcoma viral oncogene homolog B1V600, rearranged during transfection, mesenchymal epithelial transition [MET] exon 14 skipping mutation, neurotrophic tyrosine receptor kinase, and kirsten rat sarcoma G12C) should have received the respective targeted therapy and 1 line of platinum-based chemotherapy and anti-PD-1/PD-L1 (if appropriate).
-Participants who have received or been intolerant to treatment with either trifluridine/tipiracil (TAS-102), regorafenib or fruquintinib. Participants who have been treated with all are permitted. Participants must also have been previously treated with standard approved therapies, such as: fluoropyrimidine-, oxaliplatin-, or irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) biological therapy, and, if rat sarcoma (RAS) wild-type, an anti-EGFR therapy or checkpoint inhibitors, as clinically appropriate.
-Participants should have received no more than 4 prior lines of therapies for locally advanced or metastatic cancer. Gastric adenocarcinoma
-Participants who have received or been intolerant to platinum/fluoropyrimidine doublet with or without anthracycline. Participants who are human epidermal growth factor receptor 2 (HER2) positive, PD-L1 positive or having microsatellite instability-high (MSI-H) should have received anti-HER2 and anti-PD-1/PD-L1 treatment, respectively.
-Participants should have received no more than 3 prior lines of therapies for locally advanced or metastatic cancer.
-Confirmed PD-L1 positive by an FDA approved, Conformité Européene (CE)-marked, or other health-authority equivalent test in local lab. If historical PD-L1 status is not available, participants are eligible for pre-screening.
-umor tissue: All participants must provide an existing formalin-fixed paraffin-embedded (FFPE) archival tumor sample taken within 24 months of the date of the main ICF. If the acquisition of FFPE blocks is not feasible, freshly cut slides from the eligible FFPE sample should be provided, and the slides need to have been cut within 3 months before the expected (Cycle 1 Day 1) C1D1. See the lab manual, which is provided separately, for further details. If an FFPE archival tumor sample is not available, tumor biopsy will be required before trial entry.
