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Tilsotolimod

Phase 2

Solid Tumor | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Feb 17, 2022

Target and mechanism

Molecular targetTLR9
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Tilsotolimod · 1 trial · 1 indication

Phase 2 1
NCT03865082Study of Tilsotolimod in Combination With Nivolumab and Ipilimumab for the Treatment of Solid Tumors (ILLUMINATE-206)Solid Tumor
ACTIVE NOT_RECRUITING30 Analytics
PHASE2ACTIVE NOT_RECRUITING
Study of Tilsotolimod in Combination With Nivolumab and Ipilimumab for the Treatment of Solid Tumors (ILLUMINATE-206)
Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Demonstrate the efficacy of intratumoral tilsotolimod in combination with ipilimumab and nivolumab for each cohort
ORR defined as a CR or partial response (PR) according to RECIST v1.1, confirmed by imaging ≥ 4 weeks after the initial documentation of response (to occur up to 24 months).

Efficacy measure by objective response rate

Duration of response
DOR will be evaluated every 8 weeks starting Cycle3 Day1 (each cycle is 28 days) for year 1 then every 12 weeks after the first year through study completion until all study participants have either progressive disease or start new anticancer treatment.

Durability or response per RECIST v1.1

Secondary Endpoints

Safety and tolerability of the combination of tilsotolimod with nivolumab and ipilimumab
At every study visit (up to 48 months)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
IO Naive Subjects MSS CRCEXPERIMENTAL8mg Tilsotolimod by intratumoral injection plus 3mg/kg Nivolumab (every three weeks for four doses followed by 480mg dose every four weeks) and 1mg/kg Ipilimumab every three weeks for four doses intravenous

Interventions

NameTypeDescription
TilsotolimodDRUG9 doses of Tilsotolimod Intratumoral injection administered as a dose of 8mg at Week 0 Day 1 (7 days prior to the start of Cycle 1), Day 1 and Day 8 of Cycle 1, and on Day 1 of Cycles 2 through 7.
NivolumabDRUGSpecified dose on specified days.
IpilimumabDRUGSpecified dose on specified days.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites3

Main Inclusion Criteria: 1. Subject must be willing and able to sign the informed consent and comply with study protocol. 2. Must be ≥ 18 years of age (males and females). 3. ≥ 1 lesion accessible for i.t. injection and biopsy(ies). 4. Eastern Cooperative Oncology Group (ECOG) performance status of...

Countries:United States
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Solid Tumor")

Frequently asked questions about Tilsotolimod

What is Tilsotolimod used for?

Tilsotolimod is an investigational oncology drug being studied for the treatment of solid tumors. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug is being evaluated in combination with other therapies in patients with solid tumors.

Who makes Tilsotolimod?

Tilsotolimod is being developed by Bristol-Myers Squibb Company, which trades on the New York Stock Exchange under the ticker symbol BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with solid tumors.

What phase is Tilsotolimod in?

Tilsotolimod is currently in Phase 2 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 an active clinical trial for the treatment of solid tumors.

What clinical trials is Tilsotolimod in?

Tilsotolimod is being evaluated in a Phase 2 clinical trial with the identifier NCT03865082, titled 'Study of Tilsotolimod in Combination With Nivolumab and Ipilimumab for the Treatment of Solid Tumors (ILLUMINATE-206)'. This trial is active but not recruiting participants and is being conducted in the United States.

Is Tilsotolimod FDA approved?

No, Tilsotolimod is not FDA approved. It is an investigational drug currently in Phase 2 clinical trials. The drug is being studied for the treatment of solid tumors, but it has not yet received regulatory approval for any indication.