A Study of TAK-500 With or Without Pembrolizumab in Adults With Select Locally Advanced or Metastatic Solid Tumors

Stopped early · Phase 1/Phase 2

Conditions studied: Pancreatic Cancer, Hepatocellular Cancer, Mesothelioma, Breast Cancer, Gastric Cancer, Esophageal Cancer, Nasopharyngeal Cancer, Kidney Cancer, Squamous Cell Cancer of Head and Neck (SCCHN), Non-small Cell Lung Cancer (NSCLC), Non-squamous

In brief

This study is about TAK-500, given either alone or with pembrolizumab, in adults with select locally advanced or metastatic solid tumors. The aims of the study are: * to assess the safety profile of TAK-500 when given alone and when given with pembrolizumab. * to assess the anti-tumor effects of TAK-500, when given alone and when given with pembrolizumab, in adults with locally advanced or metastatic solid tumors. Participants may receive TAK-500 for up to 1 year. Participants may continue with their treatment if they have continuing benefit and if this is approved by their study doctor. Participants who are receiving TAK-500 either alone or with pembrolizumab will continue with their treatment until their disease progresses or until they or their study doctor decide they should stop this treatment.

Key facts

Study ID

NCT05070247

Run by

Takeda

People needed

61

Starts

2022-04-14

Expected to finish

2025-01-06

Last updated by the study team

2026-01-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
• Individuals with the following pathologically confirmed (cytological diagnosis is adequate) select locally advanced or metastatic solid tumors, whose disease has progressed on or are intolerant to standard therapy:
• Gastroesophageal (esophageal, gastroesophageal junction, and gastric) adenocarcinoma, pancreatic adenocarcinoma, hepatocellular carcinoma (HCC), nonsquamous non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), mesothelioma, triple-negative breast cancer (TNBC), renal clear cell carcinoma (RCC) and nasopharyngeal carcinoma (NPC). Participants who are intolerant to all standard therapies are those who have developed clinical or laboratory abnormalities that prevent continued drug administration as evaluated by the principal investigator at the time of screening.
• For dose expansion in 2L nonsquamous NSCLC (TAK-500 plus pembrolizumab):
• Participants with pathologically confirmed (cytological diagnosis is adequate) locally advanced or metastatic nonsquamous NSCLC.
• Participants may not have a known targetable driver mutation, rearrangement or amplification (eg, EGFR, ALK, MET, ROS1, BRAF, KRASG12C, etc.).
• Must have had disease progression while on or following 1 prior line of therapy:
• Disease progression while on or following at least 6 weeks of 1 prior anti-PD-(L)1 therapy in the recurrent locally advanced or metastatic setting. OR Disease progression/recurrence within 6 months of the completion of anti-PD-(L)1 therapy if administered in the adjuvant/neoadjuvant setting. Prior anti-PD-(L)1 therapy may have been given with or without an anti-CTLA4 antibody and/or chemotherapy (eg, carboplatin and pemetrexed).
• Participants are eligible regardless of PD-L1 status.
• For dose expansion in 3L nonsquamous NSCLC (TAK-500 SA):
• Participants with pathologically confirmed (cytological diagnosis is adequate) locally advanced or metastatic nonsquamous NSCLC.
• Participants may not have a known targetable driver mutation, rearrangement or amplification (eg, EGFR, ALK, MET, ROS1, BRAF, KRASG12C, etc.).
• Must have had disease progression while on or following 2 prior lines of therapy:
• Disease progression while on or following at least 6 weeks of 1 prior anti-PD-(L)1 therapy in the recurrent locally advanced or metastatic setting OR Disease progression/recurrence within 6 months of the completion of 1 prior anti-PD-(L)1 therapy if administered in the adjuvant/neoadjuvant setting. Prior anti-PD-(L)1 therapy may have been given with or without an anti-CTLA4 antibody and/or chemotherapy (eg, carboplatin and pemetrexed).
• Participants must have had disease progression while on or after 1 or 2 lines of chemotherapy in the recurrent locally advanced or metastatic setting. If the anti-PD-(L)1 therapy is given in combination with chemotherapy, participant must have progressed on an additional line of chemotherapy.
• Participants are eligible regardless of PD-L1 status.
• For dose expansion in 2L pancreatic adenocarcinoma (TAK-500 SA and TAK-500 plus pembrolizumab):
• Participants with pathologically confirmed (cytological diagnosis is adequate) locally advanced or metastatic pancreatic adenocarcinoma.
• Must have had disease progression while on or following 1 prior line of therapy:
• One prior line of fluorouracil- or gemcitabine-based chemotherapy (eg, FOLFIRINOX, FOLFOX, FOLFIRI, gemcitabine/nab-paclitaxel) in the metastatic/recurrent locally advanced setting. Prior chemotherapy in the neoadjuvant/adjuvant setting does not qualify unless the participant had progression of disease within 6 months of completion of neoadjuvant/adjuvant chemotherapy.
• Must not have had prior exposure to anti-PD-(L)1 therapy.
• Participants with MSI-H/dMMR disease are not eligible.
• Participants are eligible regardless of PD-L1 status.
• For dose expansion in 3L RCC (TAK-500 plus pembrolizumab):
• Participants with pathologically confirmed (cytological diagnosis is adequate) locally advanced or metastatic RCC.

You may not qualify if…

• History of any of the following <=6 months before first dose of study drug(s): congestive heart failure New York Heart Association Grade III or IV, unstable angina, myocardial infarction, persistent hypertension >=160/100 millimeters of mercury (mmHg) despite optimal medical therapy, ongoing cardiac arrhythmias of Grade >2 (including atrial flutter/ fibrillation or intermittent ventricular tachycardia), other ongoing serious cardiac conditions (example, Grade 3 pericardial effusion or Grade 3 restrictive cardiomyopathy), or symptomatic cerebrovascular events. Chronic, stable atrial fibrillation on stable anticoagulation therapy, including low molecular-weight heparin, is allowed.
• QT interval with Fridericia correction method >450 milliseconds (men) or >475 milliseconds (women) on a 12- lead ECG during the screening period.
• Grade >=2 hypotension (that is, hypotension for which nonurgent intervention is required) at screening or during C1D1 predose assessment.
• Oxygen saturation <92% on room air at screening or during C1D1 predose assessment.
• Treatment with other STING agonists/antagonists, Toll-like receptor agonists or CCR2 agonist/antagonist within the past 6 months.
• Active diagnosis of pneumonitis, interstitial lung disease, severe chronic obstructive pulmonary disease, idiopathic pulmonary fibrosis, other restrictive lung diseases, acute pulmonary embolism, or Grade >=2 pleural effusion not controlled by tap or requiring indwelling catheters.
• Grade >=2 fever of malignant origin.
• Chronic, active hepatitis (example, participants with known hepatitis B surface antigen seropositive and/or detectable hepatitis C virus [HCV] RNA).
• History of hepatic encephalopathy.
• Prior or current clinically significant ascites, as measured by physical examination, that requires active paracentesis for control.
• Treatment with any investigational products or other anticancer therapy (including chemotherapy, targeted agents, and immunotherapy), within 14 days or 5 half-lives, whichever is shorter, before C1D1 of study drug(s).
• Radiation therapy within 14 days (42 days for radiation to the lungs) and/ or systemic treatment with radionuclides within 42 days before C1D1 of study drug(s). Participants with clinically relevant ongoing pulmonary complications from prior radiation therapy are not eligible.
• Use of systemic corticosteroids or other immunosuppressive therapy, concurrently or within 14 days of C1D1 of study drug(s), with the following exceptions:
• Topical, intranasal, inhaled, ocular, intra-articular, and/or other nonsystemic corticosteroids.
• Physiological doses of replacement steroid therapy (example, for adrenal insufficiency), not to exceed the equivalent of 10 mg prednisone daily.
• Recipients of allogeneic or autologous stem cell transplantation or organ transplantation.
• Additional criteria specific for participants in TAK-500 and pembrolizumab combination arm only:
• Contraindication to the administration of a pembrolizumab or prior intolerance to pembrolizumab or other anti-PD-1 or anti-programmed cell death protein ligand 1 antibody.
• History of intolerance to any component of the study treatment agents or known serious or severe hypersensitivity reaction to any of the study drugs or their excipients. (Pembrolizumab is formulated with L-histidine, polysorbate 80, and sucrose.

Where it is running

• Univeristy of Alabama at Birmingham — Birmingham, Alabama, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• University of California San Diego — La Jolla, California, United States
• University of Colorado - Anschutz Medical Campus - PPDS — Aurora, Colorado, United States
• Sarah Cannon Research Institute — Denver, Colorado, United States
• Sylvester Comprehensive Cancer Center — Miami, Florida, United States
• Northwestern — Chicago, Illinois, United States
• Dana Farber Cancer Institute — Boston, Massachusetts, United States
• New York University — New York, New York, United States
• Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States
• Sarah Cannon Cancer Institute — Nashville, Tennessee, United States
• START South Texas Accelerated Research Therapeutics — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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