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Combination of Lonsurf and Irinotecan

Phase 2

Cholangiocarcinoma | Small molecule | Oncology |Tango Therapeutics, Inc.|Last Updated: Mar 27, 2024

Target and mechanism

ModalitySmall molecule

Also known as Lonsurf

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment28

FDA Designations

No designations recorded

Clinical trial landscape

Combination of Lonsurf and Irinotecan · 1 trial · 1 indication

Phase 2 1
NCT04059562Trifluridine/Tipiracil in Combination With Irinotecan as a Second Line Therapy in Patients With CholangiocarcinomaCholangiocarcinoma
COMPLETED28 Analytics
PHASE2COMPLETED
Trifluridine/Tipiracil in Combination With Irinotecan as a Second Line Therapy in Patients With Cholangiocarcinoma
CholangiocarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Median progression free survival (PFS)
through study completion, an average of 1 year (~4 months intervention + 6 months Follow Up)

Secondary Endpoints

Progression-free survival rate
At 4 months
Median overall survival
through study completion, an average of 1 year (~4 months intervention + 6 months Follow Up)
Response according to RECIST 1.1
through study completion, an average of 1 year (~4 months intervention + 6 months Follow Up)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
TreatmentEXPERIMENTALCombination of Lonsurf® and Irinotecan

Interventions

NameTypeDescription
Combination of Lonsurf® and IrinotecanCOMBINATION_PRODUCTTrifluridine/Tipiracil (Lonsurf®) and Irinotecan * Trifluridine/Tipiracil will be administered at a dose of 25 mg/m2 / dose twice daily on days 1-5 followed by a 9-days recovery period from day 6 trough day 14 of each 14-days treatment cycle. * Irinotecan will be administered at the same time as Trifluridine/Tipiracil (Lonsurf®) on day 1 of each cycle at a dose of 180 mg/m2 / dose.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Written informed consent incl. participation in translational research and any locally-required authorization (EU Data Privacy Directive in the EU) prior to performing any protocol-related procedures, including screening evaluations 2. Age ≥ 18 years at time of study entry 3....

Countries:Germany
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Competitive Landscape -Cholangiocarcinoma 58 trials

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Frequently asked questions about Combination of Lonsurf and Irinotecan

What is the combination of Lonsurf and Irinotecan used for?

The combination of Lonsurf and Irinotecan is being studied for use in cholangiocarcinoma and metastatic colorectal cancer. It is an investigational small molecule combination in Phase 2 clinical development, evaluated in patients with these advanced gastrointestinal cancers.

What does the combination of Lonsurf and Irinotecan target?

The combination of Lonsurf and Irinotecan targets cancer cells through the mechanisms of trifluridine/tipiracil and irinotecan. Trifluridine is a thymidine-based nucleoside analog that incorporates into DNA, while irinotecan inhibits topoisomerase I, together disrupting cancer cell replication.

Who is developing the combination of Lonsurf and Irinotecan?

Tango Therapeutics, Inc. (NASDAQ: TNGX) is developing the combination of Lonsurf and Irinotecan. The company is conducting clinical trials to evaluate this combination in patients with cholangiocarcinoma and metastatic colorectal cancer.

What phase is the combination of Lonsurf and Irinotecan in?

The combination of Lonsurf and Irinotecan is in Phase 2 clinical development. It is investigational and not yet approved by regulatory authorities. Two Phase 2 trials are listed, one completed and one currently recruiting participants.

What clinical trials is the combination of Lonsurf and Irinotecan in?

The combination is studied in NCT04059562, a completed Phase 2 trial in cholangiocarcinoma, and NCT06245356, a recruiting Phase 2 trial in metastatic colorectal cancer and gastroesophageal cancer with DPD deficiency. Both are open-label, non-randomized studies.

Is the combination of Lonsurf and Irinotecan the same as Lonsurf?

The combination of Lonsurf and Irinotecan includes Lonsurf, which is the brand name for trifluridine/tipiracil. Lonsurf is one component of the combination, and irinotecan is added to it in the studied regimen.