Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Talquetamab · 1 trial · 2 indications
Treatment-emergent adverse events (TEAEs) are defined as any adverse events (AEs) that begin or worsen on or after the start of study treatment through 28 days after the last dose of treatment drug. All AEs will be listed. Only TEAEs will be summarized. TEAEs will be summarized by Medical Dictionary for Regulatory Activities (version 23.1 or later) System Organ Class and Preferred Term. Separate tabulations will be produced for all TEAEs.
Maximum tolerated dose (MTD) is determined by the number of dose limiting toxicities (DLTs) during the first 28 days after the first administration of study treatment (Cycle 1) of each cohort. A DLT is defined as any adverse event (AE) that occurs during the DLT evaluation period which is considered related to study treatment, and also meets any of the criteria, as determined by the Data Safety Monitoring Committee (DSMC), with input from the clinical study team.
| Arm | Type | Description |
|---|---|---|
| Talquetamab with Belantamab Dose Escalation and Expansion | EXPERIMENTAL | Dose Level 1- Talquetamab 0.4mg/kg q2weeks Belantamab Mafodotin 1.4mg/kg q8weeks Dose Level 2A- Talquetamab 0.8mg/kg q2weeks Belantamab Mafodotin 1.4mg/kg q8weeks Dose Level 2B- Talquetamab 0.4mg/kg q2weeks Belantamab Mafodotin 1.9mg/kg q8weeks Dose Level 3- Talquetamab 0.8mg/kg q2weeks Belantamab Mafodotin 1.9mg/kg q8weeks Talquetamab will be administered with step up dosing on day 1, 3, 5 with or without day 7 (dependent on target dose level of 0.4mg/kg or 0.8mg/kg) of Talquetamab. Two weeks after TD1, participants will enroll on C1D1 of Tal (TD2) with Belantamab. Tal will subsequently be dosed every two weeks. Belantamab will be administered every 8 weeks on D1 of odd numbered cycles or until resolution of any ocular toxicities to Grade 1 or better. After 6 cycles of induction, participants may transition to Bela/Pom maintenance. Patients who maintain MRD negativity for at least 1 year may also hold treatment. |
| Name | Type | Description |
|---|---|---|
| Talquetamab | DRUG | Talquetamab dosed at 0.4mg/kg or 0.8mg/kg every 2 weeks |
| Belantamab mafodotin | DRUG | Belantamab mafodotin dosed at 1.4mg/kg or 1.9 mg/kg every 8 weeks |
| Pomalidomide | DRUG | Pomalidomide dosed at 4mg Day 1- 21 of 28 day cycles |
Inclusion Criteria: 1. Male or Female subjects \> 18 years of age 2. Be willing and able to provide written informed consent prior to any protocol-related procedures including screening evaluations. * Must meet 2014 International Myeloma Working Group (IMWG) guideline for diagnosis of Multiple ...
Talquetamab is an investigational therapy being studied for the treatment of relapsed or refractory multiple myeloma. It is a small molecule antibody being developed by GSK plc. The drug is currently in Phase 1 clinical development for this indication.
Talquetamab is a monoclonal antibody, indicated by its -mab suffix. It is being studied in patients with relapsed or refractory multiple myeloma. The specific molecular target of Talquetamab has not been disclosed in the available information.
Talquetamab is being developed by GSK plc, a global biopharmaceutical company. GSK is conducting clinical trials to evaluate the safety and efficacy of Talquetamab in patients with relapsed or refractory multiple myeloma.
Talquetamab is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is designed to assess the drug's safety and preliminary efficacy in patients with multiple myeloma.
Talquetamab is being studied in a Phase 1 clinical trial with the identifier NCT07720843. The trial, titled 'Talquetamab and Belantamab Mafodotin in Relapsed/Refractory Multiple Myeloma (TaBleMM)', is currently not yet recruiting and aims to enroll 50 patients with relapsed or refractory multiple myeloma.
No, Talquetamab and Belantamab Mafodotin are different drugs. They are being studied in combination in a clinical trial for relapsed or refractory multiple myeloma. Talquetamab is a monoclonal antibody developed by GSK, while Belantamab Mafodotin is a separate investigational therapy.