Lung Cancer
Conditions
Interventions
MCLA-129 will be administered as an IV infusion, once every 2 weeks (q2w) with
4-week cycles.
Sponsors
Merus N.V.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Signed informed consent before initiation of any study procedures. 2. Age >= 18 years at signature of informed consent. 3. Histologically or cytologically confirmed solid tumors with evidence of metastatic or locally advanced unresected disease that is incurable. 4. Availability of archival or a fresh tumor tissue sample. 5. Measurable disease as defined by RECIST version 1.1 by radiologic methods. 6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 7. Life expectancy >= 12 weeks, as per Investigator. 8. Adequate organ function.
Exclusion criteria
Exclusion criteria: 1. 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. 2. Known leptomeningeal involvement. 3. Participation in another clinical study or treatment with any investigational drug within 4 weeks prior to study entry. 4. Prior treatment with a bispecific EGFR-c-MET antibody. 5. 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. Note: For agents with long half-lives, enrollment before the fifth half-life requires Sponsor approval. 6. 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. 7. Persistent grade >1 clinically significant toxicities related to prior antineoplastic therapies (except for alopecia); stable sensory neuropathy = 7 days before the initiation of the study treatment. Patients with antecedents of Hepatitis B (anti-HBc positive, HbsAg and HBV-DNA negative) are eligible. 15. Positive test for Hepatitis C ribonucleic acid (HCV RNA); Note: Patients in whom HCV infection resolved spontaneously (positive HCV antibodies without detectable HCV-RNA) or those who achieved a sustained virological response after antiviral treatment and show absence of detectable HCV RNA >= 6 months (with the use of IFN-free regimens) or >= 12 months (with the use of IFN-based regimens) after cessation of antiviral treatment are eligible. 16. Known history of HIV (HIV 1/2 antibodies). HIV testing is not required unless mandated by local health authority or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase 1: Incidence and severity of DLTs during Cycle 1. Phase 2: ORR per RECIST v.1.1 based on Investigator assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase 1: - Safety: Incidence, severity and relationship of AEs and SAEs; incidence, severity and changes in laboratory values; measures and changes in ECG and vital signs. - Tolerability: Discontinuations due to AEs, dose modifications due to AEs. - Efficacy: BOR, ORR, DCR, DoR, PFS and OS, per RECIST v1.1 based on Investigator assessment. - Pharmacokinetics: MCLA-129 concentration CEOI, Cmax, C0h and PK parameters including AUC, CL, Vss, tmax and t1/2 and to develop a population PK model. - Immunogenicity: Incidence and serum titers of antidrug antibodies against MCLA-129. - Cytokines: Change from baseline in systemic cytokines. Phase 2: - Efficacy: BOR, DCR, DoR, PFS and OS, per RECIST v1.1 based on Investigator assessment. - Safety: Incidence, severity and relationship of AEs and SAEs; incidence, severity and changes in laboratory values; measures and changes in ECG and vital signs. - Tolerability: Discontinuations due to AEs, dose modifications due to AEs. - Pharmacokinetics: MCLA-129 concentration CEOI, Cmax, C0h and PK parameters including AUC, CL, Vss, tmax and t1/2 and to develop a population PK model. - Immunogenicity: Incidence and serum titers of antidrug antibodies against MCLA-129. | — |
Countries
Netherlands
Outcome results
None listed