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NKTR-255 · 2 trials · 5 indications
Safety and tolerability of NKTR-255 in combination with cetuximab as evaluated by dose limiting toxicities, incidence of drug-related Adverse Events (AEs), SAEs, and AEs leading to discontinuation, deaths, and clinical laboratory abnormalities per CTCAE 5.0
To define the MTD and/or RP2D of NKTR-255 in combination with cetuximab in R/R HNSCC or CRC for Phase 1b Dose Escalation
Safety and tolerability of NKTR-255 as evaluated by incidence of Dose Limiting Toxicities (DLTs), drug-related Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation, deaths, clinical laboratory abnormalities per CTCAE v5.
Safety and tolerability of NKTR-255 in combination with daratumumab as evaluated by incidence of drug-related AEs, SAEs, AEs leading to discontinuation, deaths, clinical laboratory abnormalities per CTCAE v5
Safety and tolerability of NKTR-255 in combination with rituximab as evaluated by incidence of drug-related AEs, SAEs, AEs leading to discontinuation, deaths, clinical laboratory abnormalities per CTCAE v5
| Arm | Type | Description |
|---|---|---|
| Dose Escalation of NKTR-255 with Cetuximab | EXPERIMENTAL | Establish RP2D, of NKTR-255 with cetuximab. |
| Dose Escalation | EXPERIMENTAL | Evaluation of NKTR-255 as: * Monotherapy * In combination with daratumumab * In combination with rituximab This phase will help to determine the RP2D of NKTR-255 |
| Dose Expansion Cohort A | EXPERIMENTAL | Evaluation of RP2D of NKTR-255 as monotherapy in patients with NHL relapsed after CAR-T |
| Dose Expansion Cohort B | EXPERIMENTAL | Evaluation of RP2D of NKTR-255 as monotherapy and in combination with SC daratumumab in patients with R/R MM |
| Dose Expansion Cohort C | EXPERIMENTAL | Evaluation of RP2D of NKTR-255 as monotherapy and in combination with rituximab in patients with R/R iNHL |
| Name | Type | Description |
|---|---|---|
| NKTR-255 | DRUG | NKTR-255 IV every 21 days |
| Cetuximab | DRUG | Cetuximab will be given at specified doses on specified days |
| NKTR-255 Q21 | DRUG | NKTR-255 administered by IV infusion every 21 days to establish safety and tolerability |
| Rituximab | DRUG | Rituximab administered intravenously at specified dose on specified days |
| Daratumumab | DRUG | Daratumumab administered subcutaneously at specified dose on specified days |
Key Inclusion Criteria: * Histologically confirmed diagnosis of a locally advanced or metastatic HNSCC or CRC. * Life expectancy \> 12 weeks as determined by the Investigator. * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1. * Measurable disease per RECIST 1.1. HNSCC: * Prog...
NKTR-255 is an investigational oncology drug being studied for the treatment of Head and Neck Squamous Cell Carcinoma and Multiple Myeloma. It has also been evaluated in Non-Hodgkin Lymphoma and Colorectal Cancer in clinical trials. The drug is in Phase 1 clinical development and is not yet approved by regulatory authorities.
NKTR-255 is being developed by Nektar Therapeutics, a biopharmaceutical company traded on the NASDAQ under the ticker symbol NKTR. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with certain types of cancer.
NKTR-255 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied in early-stage clinical trials to assess its safety, tolerability, and preliminary efficacy in patients with cancer.
NKTR-255 has been studied in two completed Phase 1 clinical trials. NCT04136756 evaluated the drug in patients with relapsed or refractory Multiple Myeloma and Non-Hodgkin Lymphoma, enrolling 30 participants. NCT04616196 studied NKTR-255 in combination with cetuximab in solid tumors, including Head and Neck Squamous Cell Carcinoma and Colorectal Cancer, enrolling 25 participants.
NKTR-255 is the primary name for this investigational drug. No alternative names have been reported for this asset. It is a small molecule being developed by Nektar Therapeutics for the treatment of certain cancers, including Multiple Myeloma and Head and Neck Squamous Cell Carcinoma.