Clinical Trial 23829

• Overview

  Study Title:

  A Phase 1/2 First-in-Human, Open-Label, Dose Escalation and Expansion Trial of TAK-505 Monotherapy in Participants with Unresectable Locally Advanced or Metastatic Solid Tumors

  Summary:

  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).

  Objective:

  Primary Objectives: * Phase 1: To characterize the safety, tolerability, and dose-limiting toxicities (DLTs) of TAK-505 to determine the recommended dose for expansion (RDE). * Phase 2: To characterize the efficacy and safety of TAK-505 in selected indication(s). Secondary Objectives: * Phase 1 and phase 2: To characterize the pharmacokinetics (PK) of TAK-505. * Phase 1: To evaluate the preliminary antitumor activity of TAK-505. * Phase 2: To evaluate the preliminary antitumor activity of TAK-505. * Phase 1 and phase 2: To characterize the potential immunogenicity of TAK-505. * Phase 2: To characterize immune-mediated changes in pretreatment versus on-treatment tumor biopsy specimens.

• Treatments

  Therapies:

  Anti-PD-L1 Bispecific Engager

  Medications:

  TAK-505 ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Aged greater than or equal to (≥) 18 years or ≥ the local legal age of majority, as applicable, at the time of signing the main informed consent form (ICF).
  • 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.
  • Tumor 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.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Participants must have at least 1 lesion that meets the definition of measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria (radiologically measured by the investigator). Lesions in previously irradiated areas (or other local therapy) should not be selected as measurable/target lesions, unless treatment was ≥12 months prior to start of treatment and/or there has been demonstrated progression in that particular lesion.
  • Adequate bone marrow function.
  • Adequate renal and liver function. Suitable venous access for the collection of trial-required blood sampling.
  • Additional Criteria will apply.

• Exclusion Criteria

  Key Exclusion Criteria:
  • History of known autoimmune disease.
  • History of brain metastasis or leptomeningeal disease.
  • History of hepatic encephalopathy.
  • Ongoing or active infection of Grade ≥2.
  • Oxygen saturation > Inflammatory process that has not resolved for ≥4 weeks before the first dose of trial intervention. Participants with chronic low-grade inflammatory processes such as radiation induced pneumonitis are excluded regardless of duration.
  • Vaccination with any live virus vaccine within 4 weeks or other vaccines within 2 weeks before the initiation of trial intervention. Inactivated annual influenza vaccination is allowed.
  • History of a bone marrow transplantation within the past 5 years or solid organ transplantation (as a recipient) and use of immunosuppressive agents.
  • Known hypersensitivity to TAK-505 or any excipient (acetate, arginine, histidine, methionine or polysorbate 80) contained in the drug or diluent formulation or known hypersensitivity to tocilizumab.
  • Major surgery or traumatic injury within 8 weeks before the first dose of trial intervention.
  • Unhealed wounds from surgery or injury.
  • Any pre-existing medical or psychiatric condition or illness, metabolic dysfunction, physical examination finding, or clinical laboratory finding that gives reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug or that would limit compliance with trial requirements or compromise ability to provide written informed consent.
  • Has a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 before the first dose of trial intervention.
  • Is capable of breastfeeding but does not agree to forego breastfeeding from the first dose of trial intervention through 180 days after the last dose of trial intervention.
  • Is a person of child-bearing potential (POCBP) but does not agree to use at least 1 form of highly effective contraception and 1 barrier method of contraception (preferably male condom) until 180 days after the last dose of trial intervention. Contraception methods may be considered highly effective if they can achieve a failure rate of > Is of male birth and fertile, and has partners of childbearing potential, but does not agree to use effective barrier contraception, that is, a condom, combined with at least 1 other form of acceptable contraception from signing of the main ICF until at least 180 days after the last dose of trial intervention.
  • Does not agree to refrain from donating gametes from signing of the main ICF until 180 days after the last dose of trial intervention.
  • Is a trial site employee, a site employee's immediate family member (for example, spouse, parent, child, and sibling), or is in a dependent relationship with a trial site employee who is involved in the conduct of this trial or may consent under duress.
  • Is considered to be vulnerable, as defined per local regulations and if exclusion is required by local regulations. Examples are persons under safeguard of justice, persons deprived of liberty by judicial or administrative decision, persons receiving psychiatric care without their consent, persons admitted to a health or social establishment for purposes other than research, persons of full age who are subject to a legal protection measure (guardianship or curatorship), and persons unable to express their consent.
  • Is unable or unwilling to comply with clinic visits and procedures outlined in the trial protocol.
  • Additional criteria will apply.

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