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Small-molecule inhibitor

RX108 for Solid Tumors

Phase 1
Waitlist Available
Research Sponsored by NeuPharma, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 and day 3: hours 0, 1, 2, 3, 5, 8
Awards & highlights

Study Summary

This trial will study a new drug, RX108, to see if it is safe and effective in treating patients with solid tumors.

Eligible Conditions
  • Solid Tumors
  • Metastatic Tumor

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 and day 3: hours 0, 1, 2, 3, 5, 8
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 and day 3: hours 0, 1, 2, 3, 5, 8 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Part 1: Maximum tolerated dose (MTD) of RX108
Part 2: Incidence of adverse events (AEs) and serious adverse events (SAEs).
Secondary outcome measures
Area under the plasma concentration-time curve (AUC)
Elimination half-life (T1/2)
Maximum observed plasma concentration (Cmax) of RX108
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose Expansion PhaseExperimental Treatment1 Intervention
In the Expansion Phase, subjects will receive RX108 at the maximum tolerated dose.
Group II: Dose Escalation PhaseExperimental Treatment1 Intervention
The Dose-Escalation Phase will employ a standard 3+3 algorithm to investigate ascending dose cohorts of RX108.

Find a Location

Who is running the clinical trial?

NeuPharma, Inc.Lead Sponsor
Lyon Gleich, MDStudy DirectorMedpace, Inc.
1 Previous Clinical Trials
39 Total Patients Enrolled

Media Library

RX108 (Small-molecule inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03646071 — Phase 1
Solid Tumors Research Study Groups: Dose Escalation Phase, Dose Expansion Phase
Solid Tumors Clinical Trial 2023: RX108 Highlights & Side Effects. Trial Name: NCT03646071 — Phase 1
RX108 (Small-molecule inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03646071 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many patients have enrolled in this trial thus far?

"Affirmative. Clinicaltrials.gov displays the data that this trial, initially posted on August 1st 2018 and most recently modified on April 12th 2022 is currently recruiting 80 patients from 2 different sites."

Answered by AI

What are the expected outcomes of this experiment?

"NeuPharma, Inc., the study sponsor, has indicated that their main objective is to measure adverse and serious adverse events between Day 1-30. Other outcomes of interest include Maximum observed plasma concentration (Cmax), Time to reach maximum concentration (Tmax) and Systemic clearance (CL)."

Answered by AI

Are there any remaining openings for participants in this research investigation?

"As indicated on clinicaltrials.gov, the enlistment process for this trial is currently ongoing. It was posted online on August 1st 2018 and its details were last modified in April of 2022."

Answered by AI

Is RX108 an acceptable option for human risk mitigation?

"With only limited data confirming its efficacy and safety, RX108 was assigned a score of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study of RX108 in Patients With Locally Advanced or Metastatic Solid Tumors
2018. "A Study of RX108 in Patients With Locally Advanced or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03646071.
~12 spots leftby Apr 2025
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