Informations générales (source: ClinicalTrials.gov)
Phase 1/2 Dose Escalation and Expansion Study Evaluating MCLA-129, a Human Anti-EGFR and Anti-c-MET Bispecific Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
Interventional
Phase 1/Phase 2
Merus N.V. (Voir sur ClinicalTrials)
avril 2021
mars 2027
23 août 2024
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHI DE CRETEIL | Isabelle MONNET | 29/03/2024 01:30:17 | Contacter | ||
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HP - Hôpital Bichat | Gerard Zalcman, MD, PhD | Contact (sur clinicalTrials) | |||
| AP-HP - Hôpital Europeen Georges Pompidou | Jacques Medioni, MD, PhD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CHU de Lyon - Louis Pradel Hospital - 69677 - Bron - France | Michael Duruisseaux, MD | Contact (sur clinicalTrials) | |||
| CHU de Nantes - Hôpital Nord Laennec - 44093 - Nantes - France | Stephanie Bordenave, MD | Contact (sur clinicalTrials) | |||
| CHU de Poitiers - 86000 - Poitiers - France | Nicolas Isambert, MD | Contact (sur clinicalTrials) | |||
| CHU Hopitaux de Bordeaux - Hôpital Saint-André - 33000 - Bordeaux - France | Amaury Daste, MD | Contact (sur clinicalTrials) | |||
| Clinique de l'Europe - 80090 - Amiens - France | Charles Dayen, MD | Contact (sur clinicalTrials) | |||
| Hôpital Albert Calmette - 59037 - Lille - France | Pauline Parent, MD | Contact (sur clinicalTrials) | |||
| Hôpital d'Instruction des Armées Bégin - 94163 - Saint-Mandé - France | Carole Helissey, MD | Contact (sur clinicalTrials) | |||
| L'Institut Paoli - Calmettes - 13009 - Marseille - France | Cecile Vicier, MD, PhD | Contact (sur clinicalTrials) | |||
| Marie Wislez - 75014 - Paris - France | Marie Wislez, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
Part One: Patients with NSCLC, GC/GEJ, HNSCC, or ESCC who have failed prior standard
first-line treatment. Patients must have progressed on or be intolerant to therapies that
are known to provide clinical benefit. There is no limit to the number of prior treatment
regimens.
Part Two: Patients with NSCLC, HNSCC, other solid tumors and applicable mutations as
determined by the investigator.
- Availability of archival or a fresh tumor tissue sample.
- Measurable disease as defined by RECIST version 1.1 by radiologic methods.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 12 weeks, as per Investigator.
- Adequate organ function (as per protocol)
Exclusion Criteria:
- Central nervous system metastases that are untreated or symptomatic, or require
radiation, surgery, or continued steroid therapy (> 10 mg prednisone or equivalent)
to control symptoms within 14 days of study entry.
- Known leptomeningeal involvement.
- Participation in another clinical study or treatment with any investigational drug
within 4 weeks prior to study entry.
- Systemic anticancer therapy or immunotherapy within 4 weeks or 5 half-lives,
whichever is shorter, of the first dose of study drug. For cytotoxic agents that
have major delayed toxicity (e.g., mitomycin C, nitrosoureas), a washout period of 6
weeks is required.
- Major surgery or radiotherapy within 3 weeks of the first dose of study drug.
Patients who received prior radiotherapy to ≥25% of bone marrow at any time are not
eligible.
- Persistent grade >1 clinically significant toxicities related to prior
antineoplastic therapies (except for alopecia); stable sensory neuropathy ≤ grade 2
NCI-CTCAE v5.0 and hypothyroidism ≤ grade 2 which is stable on hormone replacement
are allowed.
- History of hypersensitivity reaction or any toxicity attributed to human proteins or
any of the excipients that warranted permanent cessation of these agents. History of
hypersensitivity reaction or any toxicity attributed to chemotherapy and components.
- History of clinically significant cardiovascular disease
- Past medical history of ILD or pneumonitis, or any evidence of clinically active ILD
or pneumonitis.
- Previous or concurrent malignancy, excluding non-basal cell carcinomas of skin or
carcinoma in situ of the uterine cervix, unless the tumor was treated with curative
or palliative intent and in the opinion of the Investigator, with Sponsor agreement,
the previous or concurrent malignancy condition does not affect the assessment of
safety and efficacy of the study drug.
- Current serious illness or medical conditions including, but not limited to
uncontrolled active infection, clinically significant pulmonary, metabolic or
psychiatric disorders
- Active Hepatitis B infection without receiving antiviral treatment.
- Positive test for Hepatitis C
- Known history of HIV (HIV 1/2 antibodies). Patients with HIV with undetectable viral
load are allowed. In
first-line treatment. Patients must have progressed on or be intolerant to therapies that
are known to provide clinical benefit. There is no limit to the number of prior treatment
regimens.
Part Two: Patients with NSCLC, HNSCC, other solid tumors and applicable mutations as
determined by the investigator.
- Availability of archival or a fresh tumor tissue sample.
- Measurable disease as defined by RECIST version 1.1 by radiologic methods.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Life expectancy ≥ 12 weeks, as per Investigator.
- Adequate organ function (as per protocol)
Exclusion Criteria:
- Central nervous system metastases that are untreated or symptomatic, or require
radiation, surgery, or continued steroid therapy (> 10 mg prednisone or equivalent)
to control symptoms within 14 days of study entry.
- Known leptomeningeal involvement.
- Participation in another clinical study or treatment with any investigational drug
within 4 weeks prior to study entry.
- Systemic anticancer therapy or immunotherapy within 4 weeks or 5 half-lives,
whichever is shorter, of the first dose of study drug. For cytotoxic agents that
have major delayed toxicity (e.g., mitomycin C, nitrosoureas), a washout period of 6
weeks is required.
- Major surgery or radiotherapy within 3 weeks of the first dose of study drug.
Patients who received prior radiotherapy to ≥25% of bone marrow at any time are not
eligible.
- Persistent grade >1 clinically significant toxicities related to prior
antineoplastic therapies (except for alopecia); stable sensory neuropathy ≤ grade 2
NCI-CTCAE v5.0 and hypothyroidism ≤ grade 2 which is stable on hormone replacement
are allowed.
- History of hypersensitivity reaction or any toxicity attributed to human proteins or
any of the excipients that warranted permanent cessation of these agents. History of
hypersensitivity reaction or any toxicity attributed to chemotherapy and components.
- History of clinically significant cardiovascular disease
- Past medical history of ILD or pneumonitis, or any evidence of clinically active ILD
or pneumonitis.
- Previous or concurrent malignancy, excluding non-basal cell carcinomas of skin or
carcinoma in situ of the uterine cervix, unless the tumor was treated with curative
or palliative intent and in the opinion of the Investigator, with Sponsor agreement,
the previous or concurrent malignancy condition does not affect the assessment of
safety and efficacy of the study drug.
- Current serious illness or medical conditions including, but not limited to
uncontrolled active infection, clinically significant pulmonary, metabolic or
psychiatric disorders
- Active Hepatitis B infection without receiving antiviral treatment.
- Positive test for Hepatitis C
- Known history of HIV (HIV 1/2 antibodies). Patients with HIV with undetectable viral
load are allowed. In