Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
nal-IRI · 1 trial · 4 indications
| Arm | Type | Description |
|---|---|---|
| Nal-IRI + 5-FU + leucovorin (Arm A) | EXPERIMENTAL | nal-IRI \[Irinotecan liposome\] (80 mg/m2 as a 1.5 hour infusion), 5-FU \[5-Fluorouracil\] (2400 mg/m2 as 46 hour infusion) and leucovorin (400 mg/m2 as 0.5 hour infusion) (q2w) |
| 5-FU + leucovorin (Arm B) | OTHER | Control intervention/standard arm: 5-FU (2400 mg/m2 as 46 hour infusion) and leucovorin (400 mg/m2 as 0.5 hour infusion) (q2w) |
| Name | Type | Description |
|---|---|---|
| nal-IRI | DRUG | nal-IRI \[Irinotecan liposome\] (80 mg/m2 as a 1.5 hour infusion) |
| 5-FU | DRUG | 5-FU \[5-Fluorouracil\] (2400 mg/m2 as 46 hour infusion) |
| leucovorin | DRUG | leucovorin (400 mg/m2 as 0.5 hour infusion) |
Inclusion Criteria: 1. Written informed consent incl. participation in translational research and any locally-required authorization (EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations 2. Age ≥ 18 years...
nal-IRI is an investigational small molecule being studied for the treatment of non-resectable cholangiocarcinoma, a type of bile duct cancer. It is being evaluated in combination with 5-FU for patients with cholangio- and gallbladder carcinoma who have previously been treated with gemcitabine-based therapies.
nal-IRI is a small molecule oncology drug. The specific molecular target of nal-IRI is not disclosed in the available information. It is being studied in a biomarker-selected patient population for the treatment of non-resectable cholangiocarcinoma.
nal-IRI is being developed by Tango Therapeutics, Inc., a biopharmaceutical company. Tango Therapeutics is publicly traded on the Nasdaq stock exchange under the ticker symbol TNGX.
nal-IRI is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for the treatment of non-resectable cholangiocarcinoma in patients previously treated with gemcitabine-based therapies.
nal-IRI has been studied in one completed Phase 2 clinical trial, identified as NCT03043547. This trial evaluated nal-IRI and 5-FU compared to 5-FU alone in patients with cholangio- and gallbladder carcinoma previously treated with gemcitabine-based therapies. The trial enrolled 100 participants in Germany.
nal-IRI is also known as nal-IRI, which is a short form for nanoliposomal irinotecan. It is a liposomal formulation of the chemotherapy drug irinotecan. The drug is being developed by Tango Therapeutics for the treatment of non-resectable cholangiocarcinoma.