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Also known as zenocutuzumab (MCLA-128)
zenocutuzumab · 1 trial · 4 indications
Evaluation of clinical benefit assessed by RECIST v1.1 determining objective overall response rate (ORR)
To assess durability of anti-tumor activity of MCLA-128 in patients with NRG1 fusions as assessed locally
| Arm | Type | Description |
|---|---|---|
| Part 2 Pancreatic adenocarcinoma harboring NRG1 fusion | EXPERIMENTAL | Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks. |
| Part 2 NSCLC cancer harboring NRG1 fusion | EXPERIMENTAL | Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks. |
| Part 2 Solid tumour (basket) harboring NRG1 fusion | EXPERIMENTAL | Participants will receive intravenous infusion of 750 mg of zenocutuzumab (MCLA-128) (the recommended Phase 2 dose (RP2D)) every 2 weeks. |
| Name | Type | Description |
|---|---|---|
| zenocutuzumab (MCLA-128) | DRUG | full length IgG1 bispecific antibody targeting HER2 and HER3 |
Inclusion Criteria: * At least one measurable lesion according to RECIST v1.1 OR evaluable disease for a limited number of patients (up to 15) in Group H; * Performance status of ECOG 0 - 2; * Estimated life expectancy of at least 12 weeks; * Toxicities incurred as a result of previous anti-cancer ...
Zenocutuzumab is an investigational antibody being studied for the treatment of solid tumors harboring an NRG1 fusion, including non-small cell lung cancer and pancreatic cancer with this genetic alteration. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Zenocutuzumab is a monoclonal antibody (a -mab) designed to target tumors that harbor an NRG1 fusion. It is being evaluated in biomarker-selected patients whose cancers carry this specific genetic alteration, which is the basis for its mechanism of action in treating these solid tumors.
Zenocutuzumab is being developed by cbdMD, Inc., a company traded on the stock exchange under the ticker YCBD. The drug is currently in Phase 2 clinical trials for solid tumors harboring an NRG1 fusion.
Zenocutuzumab is in Phase 2 clinical development. It is an investigational drug being studied in patients with solid tumors harboring an NRG1 fusion, and it has not yet received FDA approval. The ongoing trial is active but not recruiting participants.
Zenocutuzumab is being studied in a single Phase 2 clinical trial with the identifier NCT02912949, titled "A Study of Zenocutuzumab (MCLA-128) in Patients With Solid Tumors Harboring an NRG1 Fusion (eNRGy)." The trial is active but not recruiting and has an enrollment of 250 participants across multiple countries.
Yes, zenocutuzumab is also known as MCLA-128. The drug is being studied under this alternative name in clinical trials, including the eNRGy study (NCT02912949), which evaluates zenocutuzumab (MCLA-128) in patients with solid tumors harboring an NRG1 fusion.