OTX-2002 + Tyrosine Kinase Inhibitor Two for Liver, Cancer of, Non-Resectable

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Next Oncology, San Antonio, TX
Liver, Cancer of, Non-Resectable+9 More
OTX-2002 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a Phase 1/2 open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of OTX-2002 as a single agent and in combination with standard of care in patients with hepatocellular carcinoma (HCC) and other solid tumor types known for association with the MYC oncogene. The study consists of Part 1 (OTX-2002 monotherapy) and Part 2 (OTX-2002 combined with standard of care in hepatocellular carcinoma). Part 1 consists of escalation and expansion, and Part 2 consists of safety run-in and expansion. The objective of Part 1 escalation and Part 2 safety run-in will be safety and tolerability, while anti-tumor activity will be evaluated as the primary endpoint in Part 1 and Part 2 expansion.

Eligible Conditions

  • Liver, Cancer of, Non-Resectable
  • Hepatocellular Carcinoma
  • Tumors, Solid
  • Non-Resectable Hepatocellular Carcinoma
  • Recurrent Hepatocellular Carcinoma
  • Liver Cancer
  • Hepatocellular Cancer (HCC)

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Liver, Cancer of, Non-Resectable

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: through treatment completion, up to two years

Week 4
Determine Dose limiting toxicities (DLT)and maximum tolerated dose ( MTD) (Part 1 escalation and Part 2 safety run-in)
Day 30
Incidence of TEAEs including all AEs,Grade 3-5 AEs, drug-related AEs, and SAEs (Part 1 escalation and Part 2 safety run-in)
through treatment completion, up to two years
Duration of Response (DOR) (for Part 1 and Part 2 expansion)
Overall response rate (ORR)(for Part 1 and Part 2 expansion)

Trial Safety

Safety Progress

1 of 3

Other trials for Liver, Cancer of, Non-Resectable

Trial Design

5 Treatment Groups

OTX-2002 + Tyrosine Kinase Inhibitor Two
1 of 5
OTX-2002 + Tyrosine Kinase Inhibitor One
1 of 5
OTX-2002 + Checkpoint Inhibitor
1 of 5
OTX-2002 + Immune Checkpoint Blockade
1 of 5
OTX-2002
1 of 5
Experimental Treatment

190 Total Participants · 5 Treatment Groups

Primary Treatment: OTX-2002 + Tyrosine Kinase Inhibitor Two · No Placebo Group · Phase 1 & 2

OTX-2002 + Tyrosine Kinase Inhibitor TwoExperimental Group · 2 Interventions: OTX-2002, Tyrosine kinase inhibitor Two · Intervention Types: Drug, Drug
OTX-2002 + Tyrosine Kinase Inhibitor OneExperimental Group · 2 Interventions: OTX-2002, Tyrosine kinase inhibitor One · Intervention Types: Drug, Drug
OTX-2002 + Checkpoint InhibitorExperimental Group · 2 Interventions: OTX-2002, Checkpoint Inhibitor, Immune · Intervention Types: Drug, Drug
OTX-2002 + Immune Checkpoint BlockadeExperimental Group · 2 Interventions: OTX-2002, Immune Checkpoint Blockade · Intervention Types: Drug, Drug
OTX-2002
Drug
Experimental Group · 1 Intervention: OTX-2002 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through treatment completion, up to two years
Closest Location: Next Oncology · San Antonio, TX
Photo of NEXT Oncology Austin  1Photo of NEXT Oncology San Antonio  2Photo of NEXT Oncology Virginia  3
2020First Recorded Clinical Trial
1 TrialsResearching Liver, Cancer of, Non-Resectable
2 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have metastatic, advanced (non-resectable), or recurrent solid tumor who progressed on, relapsed after, are refractory to, or intolerant of standard of care (only applicable to Part 1 escalation).
You have hepatocellular carcinoma and are not amenable to locoregional therapy, refractory to locoregional therapy or not amenable to curative treatment approach.
You have a performance status of 0 or 1.
Key exclusion criteria for this condition.
You have cholangiocarcinoma or fibrolamellar variant HCC.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.