A Study of TAK-505 in Adults With Solid Tumors
ConditionMalignant Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTakeda
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Gastric adenocarcinoma.
Colorectal cancer (CRC).
Non-small cell lung cancer (NSCLC) (both squamous and non-squamous).
Disqualifiers
History of hepatic encephalopathy.
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.
Trial design
Design model
Sequential
Treatments tested in this trial
TAK-505
DrugParticipants will receive TAK-505 intravenously (IV)
Treatment groups
151 Participants
are divided into 2 treatment groupsGroup A: Phase 1: TAK-505 Dose EscalationExperimental treatment 1 intervention
Group B: Phase 2: TAK-505 Dose ExpansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From initial dose until 28 days after infusion of the first cohort dose on Cycle 1 Day 12
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.
Time frame
From first dose of trial intervention through 30 days after administration of the last dose of trial intervention (up to approximately 52 months)3
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)
Time frame
Up to end of study (up to approximately 52 months)4
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.
Time frame
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
1
Phase 1 and Phase 2: Maximum Observed Concentration (Cmax) of TAK-505
The cycle length for each cycle is 28 days.
Time frame
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)2
Phase 1 and Phase 2: Time to Maximum Concentration (tmax) of TAK-505
The cycle length for each cycle is 28 days.
Time frame
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)3
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
The cycle length for each cycle is 28 days.
Time frame
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)4
Phase 1 and Phase 2: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of TAK-505
The cycle length for each cycle is 28 days.
Time frame
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) Source ClinicalTrials.gov