OUR TRIALS
Welcome to INTR@PID Clinical Trials - a program investigating the effect of bintrafusp alfa, a bifunctional fusion protein designed to target tumors via colocalized, simultaneous inhibition of the TGF-β and PD-L1 pathways, in multiple cancer types.
Bintrafusp alfa is under clinical investigation and has not been proven to be safe and effective. There is no guarantee that bintrafusp alfa will be approved in the sought-after indication by any health authority worldwide.
Find out more about each of our trials below.
An adaptive phase 3, randomized, open-label, controlled study evaluating bintrafusp alfa versus pembrolizumab in the first-line treatment of patients with stage IV non-small cell lung cancer (NSCLC) that has high expression of PD-L1.*
ClinicalTrials.gov: NCT03631706
Location: Global
Status:
Active, Not Recruiting
*PD-L1–high expression as determined by central testing.
A phase 2, randomized, controlled study evaluating bintrafusp alfa with concurrent chemoradiation (cCRT) followed by bintrafusp alfa versus placebo with cCRT followed by durvalumab for the treatment of patients with unresectable stage III non-small cell lung cancer (NSCLC).
ClinicalTrials.gov: NCT03840902
Location: Global
Status:
Now Enrolling
A phase 1b/2, open-label study evaluating bintrafusp alfa with chemotherapy for the treatment of patients with stage IV non-small cell lung cancer (NSCLC).
ClinicalTrials.gov: NCT03840915
Locations: Europe and North America
Status:
Active, Not Recruiting
A phase 2, single-arm study evaluating bintrafusp alfa in the second-line treatment of patients with locally advanced or metastatic biliary tract cancer (BTC) who have failed or are intolerant to first-line platinum-containing chemotherapy.
ClinicalTrials.gov: NCT03833661
Location: Global
Status:
Active, Not Recruiting
A safety run-in followed by a phase 2/3, randomized, placebo-controlled study evaluating bintrafusp alfa with gemcitabine plus cisplatin in the first-line treatment of patients with locally advanced or metastatic biliary tract cancer (BTC).
ClinicalTrials.gov: NCT04066491
Location: Global
Status:
Now Enrolling
A phase 2, single-arm study evaluating bintrafusp alfa for the treatment of patients with advanced unresectable and/or metastatic cervical cancer who had disease progression with platinum-containing chemotherapy.*
ClinicalTrials.gov: NCT04246489
Location: Global
Status:
Active, Not Recruiting
*Platinum-containing chemotherapy may have been a systemic treatment for advanced unresectable, recurrent, persistent, or metastatic disease, or given in the adjuvant/neoadjuvant setting with disease progression or recurrence within 6 months of treatment completion. Patients who previously only received platinum as a radlosensitizer are not eligible.
A phase 1, open-label study evaluating bintrafusp alfa with other anticancer therapies for the treatment of patients with locally advanced or persistent, recurrent, or metastatic cervical cancer.
ClinicalTrials.gov: NCT04551950
Location: Global
Status:
Now Enrolling
A phase 1b, single-arm study evaluating bintrafusp alfa for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer that progressed or recurred after platinum-containing chemotherapy.*
Status:
Now Enrolling
*Must have experienced disease progression or recurrence either following platinum-containing chemotherapy given for unresectable locally advanced or metastatic urothelial cancer or within 12 months from completion of neoadjuvant or adjuvant platinum-containing chemotherapy for localized muscle-invasive urothelial cancer.
A phase 2, single-arm study evaluating bintrafusp alfa for the treatment of patients with metastatic triple-negative breast cancer (TNBC) that has high expression of HMGA2.*
ClinicalTrials.gov: NCT04489940
Locations: Europe and North America
Status:
Now Enrolling
*HMGA2-high tumor expression will be determined by a centralized RT-PCR test.
A phase 1, open-label, multiple ascending-dose trial to investigate the safety, tolerability, pharmacokinetics, and biological and clinical activity of bintrafusp alfa in patients with metastatic or locally advanced solid tumors and expansion to selected indications.
ClinicalTrials.gov: NCT02517398
Location: Global
Status:
Active, Not Recruiting
A phase 1, open-label, multiple ascending-dose trial to investigate the safety, tolerability, pharmacokinetics, and biological and clinical activity of bintrafusp alfa in patients with metastatic or locally advanced solid tumors, with expansion to selected indications in Asia.
ClinicalTrials.gov: NCT02699515
Location: Asia
Status:
Active, Not Recruiting
