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TKM-080301

Phase 1

Cancer | Small molecule | Oncology |Arbutus Biopharma Corporation|Last Updated: Jan 16, 2019

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment68

FDA Designations

No designations recorded

Clinical trial landscape

TKM-080301 · 2 trials · 9 indications

Phase 1 2
NCT02191878Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Intravenous TKM-080301 in Subjects With Advanced Hepatocellular CarcinomaHepatocellular Carcinoma
COMPLETED43 Analytics
NCT01262235A Dose Finding Study of TKM-080301 Infusion in Neuroendocrine Tumors (NET) and Adrenocortical Carcinoma (ACC) PatientsCancer
COMPLETED68 Analytics
PHASE1COMPLETED
Safety, Pharmacokinetics and Preliminary Anti-Tumor Activity of Intravenous TKM-080301 in Subjects With Advanced Hepatocellular Carcinoma
Hepatocellular CarcinomaUnlock trial analytics
PHASE1COMPLETED
A Dose Finding Study of TKM-080301 Infusion in Neuroendocrine Tumors (NET) and Adrenocortical Carcinoma (ACC) Patients
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum tolerated dose (MTD)
Up to 6 months after initial dose.

Laboratory assessments

Safety and tolerability of treatment with TKM-080301
6 months
Determine dose-limiting toxicities and maximum tolerated dose of TKM-080301
6 months

Secondary Endpoints

Preliminary assessment of anti-tumor activity by Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1)
Upon every 2 cycles of treatment for up to 6 months
Clinical Benefit Rate at maximum tolerated dose (MTD) in Expansion Cohort
Upon completion of treatment of expansion cohort; up to 6 months after last participant is dosed.
Characterize the pharmacokinetics of TKM-080301
2 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phase 1 Escalation / Phase 2 ExpansionEXPERIMENTALPhase 1 - dose escalation with intravenous infusion of TKM-080301 to determine MTD. Phase 2 - dose expansion at the MTD.
TKM-080301EXPERIMENTAL -

Interventions

NameTypeDescription
TKM-080301DRUGTKM-080301 intravenous infusion
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Key Inclusion Criteria: * Child-Pugh class of A * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤5.0 × ULN * Total bilirubin ≤3.0 mg/dL * Platelets ≥75,000 /mL * International Normalized Ratio (INR) ≤1.7 ...

Countries:United StatesCanadaChinaSingaporeSouth KoreaTaiwan
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Frequently asked questions about TKM-080301

What is TKM-080301 used for?

TKM-080301 is an investigational small molecule being studied for the treatment of cancer, including hepatocellular carcinoma. It has been evaluated in Phase 1 clinical trials for advanced hepatocellular carcinoma and for neuroendocrine tumors and adrenocortical carcinoma. It is not approved and remains in clinical development.

Who makes TKM-080301?

TKM-080301 is being developed by Arbutus Biopharma Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol ABUS. The company has conducted Phase 1 clinical trials of this investigational drug for cancer indications.

What phase is TKM-080301 in?

TKM-080301 is in Phase 1 clinical development. It has completed two Phase 1 trials, one in neuroendocrine tumors and adrenocortical carcinoma and another in advanced hepatocellular carcinoma. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is TKM-080301 in?

TKM-080301 has been studied in two completed Phase 1 trials. NCT01262235 evaluated the drug in patients with neuroendocrine tumors and adrenocortical carcinoma, enrolling 68 participants in the United States. NCT02191878 studied the drug in advanced hepatocellular carcinoma, enrolling 43 participants across the United States, Canada, China, Singapore, South Korea, and Taiwan.

Is TKM-080301 the same as any other drug?

TKM-080301 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 Arbutus Biopharma Corporation for oncology indications.