A Phase I/II Study of MCLA-128, a full length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients with Solid Tumors (eNRGy)

Conditions

Solid Tumors

Brief summary

Part 1: Evaluation of adverse events (AEs) and dose limiting toxicities (DLT)., Part 2: Groups A - E, and F: • Frequency and nature of AEs. • Overall response rate (ORR), Duration of Response (DOR), Clinical Benefit Rate (CBR), Part 2: Groups F, G, H (NRG1 fusion): • ORR per RECIST v1.1 as per local Investigator's assessment. • DOR per RECIST v1.1 as per local Investigator's assessment.

Detailed description

Part 1: 1. Frequency and nature of AEs/serious adverse events (SAEs). 2. Assessment of PK variables. 3. Incidence and serum titers of anti-drug antibodies against MCLA-128. 4. Anti-tumor activity and clinical benefit assessed by RECIST v1.1 determining ORR, DOR, progression-free survival (PFS) and survival., Part 2: Groups A - E, and F : 5. Assessment of PK variables. 6. Population PK analysis. 7. Incidence and serum titers of anti-drug antibodies against MCLA-128., Part 2: Groups F, G, H (NRG1 fusion): ORR per RECIST v1.1. CBR per RECIST v1.1. DOR per RECIST v1.1. Time to response per RECIST v1.1 Frequency and nature of AEs. Assessment of PK variables. Population PK analysis. Incidence and serum titers of anti-drug antibodies against MCLA-128.

Related papers

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Interventions

DRUGMCLA-128

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part 1: Evaluation of adverse events (AEs) and dose limiting toxicities (DLT)., Part 2: Groups A - E, and F: • Frequency and nature of AEs. • Overall response rate (ORR), Duration of Response (DOR), Clinical Benefit Rate (CBR), Part 2: Groups F, G, H (NRG1 fusion): • ORR per RECIST v1.1 as per local Investigator's assessment. • DOR per RECIST v1.1 as per local Investigator's assessment.	—

Secondary

Measure	Time frame
Part 1: 1. Frequency and nature of AEs/serious adverse events (SAEs). 2. Assessment of PK variables. 3. Incidence and serum titers of anti-drug antibodies against MCLA-128. 4. Anti-tumor activity and clinical benefit assessed by RECIST v1.1 determining ORR, DOR, progression-free survival (PFS) and survival., Part 2: Groups A - E, and F : 5. Assessment of PK variables. 6. Population PK analysis. 7. Incidence and serum titers of anti-drug antibodies against MCLA-128., Part 2: Groups F, G, H (NRG1 fusion): ORR per RECIST v1.1. CBR per RECIST v1.1. DOR per RECIST v1.1. Time to response per RECIST v1.1 Frequency and nature of AEs. Assessment of PK variables. Population PK analysis. Incidence and serum titers of anti-drug antibodies against MCLA-128.	—

Measure

Time frame

Part 1: 1. Frequency and nature of AEs/serious adverse events (SAEs). 2. Assessment of PK variables. 3. Incidence and serum titers of anti-drug antibodies against MCLA-128. 4. Anti-tumor activity and clinical benefit assessed by RECIST v1.1 determining ORR, DOR, progression-free survival (PFS) and survival., Part 2: Groups A - E, and F : 5. Assessment of PK variables. 6. Population PK analysis. 7. Incidence and serum titers of anti-drug antibodies against MCLA-128., Part 2: Groups F, G, H (NRG1 fusion): ORR per RECIST v1.1. CBR per RECIST v1.1. DOR per RECIST v1.1. Time to response per RECIST v1.1 Frequency and nature of AEs. Assessment of PK variables. Population PK analysis. Incidence and serum titers of anti-drug antibodies against MCLA-128.

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Countries

Austria, Belgium, Denmark, France, Germany, Italy, Netherlands, Norway, Spain, Sweden

Outcome results

None listed