Phase 1a:Dose escalation for Cutaneous Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The University of Texas MD Anderson Cancer Center, Houston, TX
Cutaneous Tumors+3 More
JCXH-211 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

A Phase 1 Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of JCXH-211 Intratumoral Injection in Patients with Malignant Solid Tumors

Eligible Conditions

  • Cutaneous Tumors
  • Solid Malignant Tumors

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 6 Secondary · Reporting Duration: Up to 24 months

Day 29
Dose limiting toxicity
Day 30
Incidence of adverse events (Safety and Tolerability)
Up to 12 months
Disease control rate (DCR)
Objective response rate (ORR)
Progression-free survival (PFS)
Month 12
Duration of response (DOR)
Month 12
Time to response (TTR)
Up to 24 months
Overall survival (OS)

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Phase 1a:Dose escalation
1 of 2
Phase 1b:Dose expansion
1 of 2
Experimental Treatment

144 Total Participants · 2 Treatment Groups

Primary Treatment: Phase 1a:Dose escalation · No Placebo Group · Phase 1

Phase 1a:Dose escalation
Drug
Experimental Group · 1 Intervention: JCXH-211 · Intervention Types: Drug
Phase 1b:Dose expansion
Drug
Experimental Group · 1 Intervention: JCXH-211 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months
Closest Location: The University of Texas MD Anderson Cancer Center · Houston, TX
Photo of the university of texas md anderson cancer center  1Photo of the university of texas md anderson cancer center  2Photo of the university of texas md anderson cancer center  3
2006First Recorded Clinical Trial
1 TrialsResearching Cutaneous Tumors
149 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are either male or female and are between the ages of 18 and 75.
You have a malignant solid tumor that has been diagnosed by pathology and/or cytology.
You have at least one non-injected measurable tumor lesion per RECIST v1.1.
You have a primary tumor in the brain and are treated for metastatic disease.
Patients must be ≥ 4 weeks beyond treatment with any chemotherapy (6 weeks for nitrosoureas or mitomycin C), hormonal, biological, targeted agents, other investigational therapy or radiotherapy.

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.