Phase I/II 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
Study Identifier:
MCLA-129-CL01
CT.gov Identifier:
EudraCT Identifier:
EU Trial (CTIS) Number:
Study Contact Information:
Recruitment Complete
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Study Summary
To evaluate MCLA129 for the treatment of patients with advanced solid tumors with abnormal EGFR or MET.
To evaluate safety , efficacy and dose escalation of MCLA-129 as monotherapy in patients with NSCLC, or HNSCC or other solid tumors
Phase 1
To evaluate the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) of single-agent MCLA-129 in patients with NSCLC, GC/GEJ adenocarcinoma, HNSCC or ESCC, with disease progression after prior therapy for advanced/metastatic disease.
Phase 2
To evaluate the ORR in molecularly defined populations of advanced/metastatic solid tumors including NSCLC, GC/GEJ adenocarcinoma, and other selected solid tumors selected according to their molecular profile.
Tumor imaging was conducted Q8W.
Biomarker analyses of EGFR/c-MET expression and ctDNA mutation status are planned.
Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I/II
Sex
Female & Male
Age
18+ years
Study Drug
Study Status
Indicates the current recruitment status or the expanded access status
Recruitment Complete
Requirements information
Inclusion criteria
- 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
Clinical Study Information for Healthcare Providers
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Study Locations
Location
Investigator
Status
Condition(s) Treated at Site
Location
START Barcelona
Barcelona, Spain, 08023
Investigator
Tatiana Hernandez Guerrero
Status
Recruiting
Condition(s) Treated at Site
Non-Small Cell Lung Cancer
Gastric
Esophageal
Head & Neck
Bowel (Colorectal)
Location
START Madrid, Spain (FJD)
Madrid, Spain, 28040
Investigator
Victor Moreno Garcia
Status
Recruitment Complete
Condition(s) Treated at Site
Non-Small Cell Lung Cancer
Gastric
Esophageal
Head & Neck
Bowel (Colorectal)
Location
START Madrid, Spain (CIOCC)
Madrid, Spain, 28050
Investigator
Irene Moreno
Status
Recruitment Complete
Condition(s) Treated at Site
Non-Small Cell Lung Cancer
Gastric
Esophageal
Head & Neck
Bowel (Colorectal)