A Study of TAK-505 in Adults With Solid Tumors

NCT07436728 | Recruiting Phase 1 FDA Drug

• 1 other identifier: TAK-505-1501
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 15

Brief 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).

Conditions

Malignant Solid Tumors

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (4)

• Phase 1 Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)

  DLTs are defined as specific Grade 3 and 4 hematologic and hepatic nonhematologic events or any other Grade ≥3 adverse events related to treatment that occur during the DLT evaluation period after administration of TAK-505, except events that are clearly due to the underlying disease or an extraneous cause.

  From initial dose until 28 days after infusion of the first cohort dose on Cycle 1 Day 1

• Phase 1 Dose Escalation: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Clinically Significant Laboratory Values and Vital Signs

  An Adverse Event (AE) is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of TAK-505, whether or not the occurrence is considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of TAK 505. TEAEs that occur after administration of the first dose of trial intervention and through 30 days after the last dose of trial intervention will be tabulated.

  From first dose of trial intervention through 30 days after administration of the last dose of trial intervention (up to approximately 52 months)

• Phase 2 Dose Expansion: Confirmed Overall Response Rate (ORR)

  ORR is defined as the percentage of participants who achieve partial response (PR) or complete response (CR), as assessed by the investigator, per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)

  Up to end of study (up to approximately 52 months)

• Phase 2 Dose Expansion: Number of Participants With TEAEs, Clinically Significant Laboratory Values and Vital Signs

  An AE is any untoward medical occurrence in a clinical trial participant, temporally associated with the use of TAK-505, whether or not the occurrence is considered related to the trial intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of TAK 505. TEAEs that occur after administration of the first dose of trial intervention and through 30 days after the last dose of trial intervention will be tabulated.

  From first dose of trial intervention through 30 days after administration of the last dose of trial intervention (up to approximately 52 months)

Secondary Outcomes (16)

• Phase 1 and Phase 2: Maximum Observed Concentration (Cmax) of TAK-505

  Phase 1, all cycles: pre-dose and end of infusion (EOI) except Cycles 1 and 3: Day1-pre-dose and post dose up to 168 hours; Day 15-pre-dose and EOI; End of treatment (EOT) (up to 7 months); Phase 2, all Cycles: pre-dose, EOI and EOT (up to 9 months)

• Phase 1 and Phase 2: Time to Maximum Concentration (tmax) of TAK-505

  Phase 1, all cycles: pre-dose and EOI except Cycles 1 and 3: Day1-pre-dose and post dose up to 168 hours; Day 15-pre-dose and EOI; EOT (up to 7 months); Phase 2, all Cycles: pre-dose, EOI and EOT (up to 9 months)

• Phase 1 and Phase 2: Area Under the Concentration-Time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC0-last) of TAK-505

  Phase 1, all cycles: pre-dose and EOI except Cycles 1 and 3: Day1-pre-dose and post dose up to 168 hours; Day 15-pre-dose and EOI; EOT (up to 7 months); Phase 2, all Cycles: pre-dose, EOI and EOT (up to 9 months)

• Phase 1 and Phase 2: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of TAK-505

  Phase 1, all cycles: pre-dose and EOI except Cycles 1 and 3: Day1-pre-dose and post dose up to 168 hours; Day 15-pre-dose and EOI; EOT (up to 7 months); Phase 2, all Cycles: pre-dose, EOI and EOT (up to 9 months)

• Phase 1 and Phase 2: Terminal Phase Half-Life (t1/2z) of TAK-505

  Phase 1, all cycles: pre-dose and EOI except Cycles 1 and 3: Day1-pre-dose and post dose up to 168 hours; Day 15-pre-dose and EOI; EOT (up to 7 months); Phase 2, all Cycles: pre-dose, EOI and EOT (up to 9 months)

Study Arms (2)

Phase 1: TAK-505 Dose Escalation

EXPERIMENTAL

Participants will receive TAK-505 intravenous (IV) infusion until disease progression intolerability, or any other treatment discontinuation criterion is met.

Drug: TAK-505

Phase 2: TAK-505 Dose Expansion

EXPERIMENTAL

Participants with up to 3 selected tumor indications will receive the recommended dose for expansion (RDE) until disease progression intolerability, or any other treatment discontinuation criterion is met.

Drug: TAK-505

Interventions

TAK-505 DRUG

Participants will receive TAK-505 intravenously (IV)

Phase 1: TAK-505 Dose Escalation; Phase 2: TAK-505 Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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:
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• 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 should have received no more than 3 prior lines of therapies for locally advanced or metastatic cancer.
• \. CRC: adenocarcinoma
• 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.

You may not qualify if:

• History of known autoimmune disease, except for:
• a) Vitiligo. b) Psoriasis not requiring systemic treatment for \>1 year before receipt of TAK-505.
• c) History of Graves' disease in participants now euthyroid for \>4 weeks. d) Hypothyroidism managed by thyroid hormone replacement. e) Alopecia. f) Well-controlled diabetes type 1.
• History of brain metastasis or leptomeningeal disease unless:
• a) Brain metastases are stable on cranial imaging (that is, ≥4 weeks) following prior surgery, whole-brain radiation OR b) Received stereotactic radiosurgery and is off corticosteroids for brain metastases AND c) Is without neurologic dysfunction that would confound the evaluation of neurologic and other adverse events (AEs).
• History of any of the following ≤6 months before the first dose of trial intervention:
• a) Congestive heart failure New York Heart Association (NYHA) Grade III or IV. b) Unstable angina. c) Myocardial infarction. d) Unstable symptomatic ischemic heart disease. e) Uncontrolled hypertension despite appropriate medical therapy. f) Any ongoing symptomatic cardiac arrhythmias of Grade greater than (\>) 2 (including acute atrial flutter/fibrillation, ventricular fibrillation, or ventricular tachycardia). Chronic, stable atrial fibrillation on stable anticoagulant therapy, including lowmolecular-weight heparin, is allowed.
• g) Acute symptomatic pulmonary embolism, or symptomatic cerebrovascular events, or any other serious cardiac condition (for example, pericardial effusion or restrictive cardiomyopathy).
• h) Left ventricular ejection fraction (LVEF) less than (\<) 50%, as measured by echocardiogram or multigated acquisition scan (MUGA) within 4 weeks before receiving the first dose of trial intervention.
• History of hepatic encephalopathy.
• Active diagnosis of a lung condition including:
• a) Pneumonitis b) Interstitial lung disease c) Severe chronic obstructive pulmonary disease d) Idiopathic pulmonary fibrosis e) Other restrictive lung diseases f) Acute symptomatic pulmonary embolism g) Grade ≥2 pleural effusion not controlled by tap or requiring indwelling catheters.
• Ongoing or active infection of Grade ≥2
• Oxygen saturation \<90% on room air at screening or during the C1D1 predose assessment.
• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (15)

UCI Health

Orange, California, 92868, United States

NOT YET RECRUITING

University of California San Diego Medical Center, La Jolla

San Diego, California, 92093, United States

NOT YET RECRUITING

University of California San Francisco

San Francisco, California, 94143, United States

NOT YET RECRUITING

H Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

NOT YET RECRUITING

Univeristy of Minnesota

Minneapolis, Minnesota, 55455, United States

NOT YET RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

NOT YET RECRUITING

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

NOT YET RECRUITING

Sarah Cannon Research Institute SCRI

Nashville, Tennessee, 37203, United States

NOT YET RECRUITING

Tennessee Oncology

Nashville, Tennessee, 37203, United States

NOT YET RECRUITING

Mary Crowley Cancer Center

Dallas, Texas, 75230, United States

NOT YET RECRUITING

Baylor College of Medicine

Houston, Texas, 77030, United States

NOT YET RECRUITING

MD Anderson

Houston, Texas, 77030, United States

NOT YET RECRUITING

NEXT Oncology

San Antonio, Texas, 78229, United States

RECRUITING

NEXT Oncology

Fairfax, Virginia, 22031, United States

RECRUITING

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

NOT YET RECRUITING

Related Links

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Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Central Study Contacts

Takeda Contact

CONTACT

+1-877-825-3327; medinfoUS@takeda.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 27, 2026
• Study Start: May 11, 2026
• Primary Completion (Estimated): August 18, 2030
• Study Completion (Estimated): August 18, 2030
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

US (15)