A phase 1/2 open-label multicenter study will be performed with an initial dose escalation part to determine the MTD and/or the RP2D of MCLA-129 in monotherapy or in combination in patients with NSCLC, HNSCC, GC/GEJ, ESCC, or other solid tumors and who are treatment naïve or have progressed after receiving prior therapy for advanced/metastatic disease.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
576
full length IgG1 bispecific antibody that specifically targets the receptor tyrosine kinases EGFR and c-MET
Approved, 3rd-generation EGFR-TKI
administrated by IV infusion
University of California, Irvine
Orange, California, United States
RECRUITINGSarah Cannon Research Institute
Nashville, Tennessee, United States
COMPLETEDSTART Mountain Region
West Valley City, Utah, United States
COMPLETEDNext Oncology Virginia
Fairfax, Virginia, United States
To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D)
To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single-agent MCLA-129 as well as in combination with chemotherapy in patients with NSCLC, GC/GEJ adenocarcinoma, HNSCC or ESCC, with disease progression after prior therapy for advanced/metastatic disease.
Time frame: First 28 days of treatment
To evaluate clinical activity, as assessed by ORR
To evaluate the ORR of MCLA-129 monotherapy or in combination with an EGFR TKI or chemotherapy in molecularly defined populations of advanced/metastatic solid tumors.
Time frame: From first dose until RECIST progression or initiation of an alternative treatment, whichever occurs first.
To evaluate preliminary antitumor activity in terms of BOR
To evaluate preliminary antitumor activity of MCLA-129 monotherapy as well as in combination with an EGFR TKI or chemotherapy in terms of best overall response (BOR)
Time frame: From first dose until RECIST progression or initiation of an alternative treatment, whichever occurs first.
To evaluate preliminary antitumor activity in terms of DCR
To evaluate preliminary antitumor activity of single-agent MCLA-129 as well as in combination with an EGFR TKI or with chemotherapy in terms of Disease Control Rate (DCR).
Time frame: From first dose until RECIST progression or initiation of an alternative treatment, whichever occurs first.
To evaluate preliminary antitumor activity in terms of DoR
To evaluate preliminary antitumor activity of single-agent MCLA-129 as well as in combination with an EGFR TKI or with chemotherapy in terms of Duration of Response (DoR)
Time frame: From first dose until RECIST progression or initiation of an alternative treatment, whichever occurs first.
To evaluate progression-free survival (PFS)
To evaluate progression-free survival (PFS) of single-agent MCLA-129 as well as in combination with an EGFR TKI or with chemotherapy.
Time frame: From first dose until RECIST progression or until 1 year after treatment, whichever occurs first.
To evaluate overall survival (OS)
To evaluate overall survival (OS) of single-agent MCLA-129 as well as in combination with an EGFR TKI or with chemotherapy.
Time frame: From first dose until RECIST progression or until 1 year after treatment, whichever occurs first.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 of single-agent MCLA-129 as well as in combination with an EGFR TKI or with chemotherapy
Time frame: From first dose until study treatment discontinuation
Proportion of patient with treatment discontinuations of single-agent MCLA-129 as well as in combination with an EGFR TKI or with chemotherapy.
Time frame: From first dose until study treatment discontinuation
AE, regardless of relationship to study treatment
Time frame: From first dose until study treatment discontinuation
All safety endpoints
including vital sign, lab, ECG, ECHO, 4 weeks CT scan, Eye exam
Time frame: From first dose until study treatment discontinuation
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Institut Jules Bordet
Anderlecht, Belgium
RECRUITINGAntwerp University Hospital
Edegem, Belgium
COMPLETEDClinique de l'Europe
Amiens, France
COMPLETEDCHU Hopitaux de Bordeaux - Hôpital Saint-André
Bordeaux, France
RECRUITINGCHU de Lyon - Louis Pradel Hospital
Bron, France
RECRUITINGCentre Hospitalier Intercommunal de Créteil
Créteil, France
RECRUITING...and 41 more locations