DRP-104 for Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Advanced Solid Tumors+7 MoreDRP-104 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is studying the safety and effectiveness of DRP-104 given by itself or with atezolizumab in treating patients with solid tumors that have spread to other parts of the body.

Eligible Conditions
  • Advanced Solid Tumors
  • Squamous Cell Carcinoma of the Head and Neck
  • Non-small Cell Lung Cancer (NSCLC), Recurrent
  • Non-Small Cell Lung Cancer Metastatic

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 8 Secondary · Reporting Duration: anticipated 2 year

anticipated 1 year
Area under the plasma concentration versus time curve (AUC)
Cmax of DRP-104
Maximum Tolerated Dose (MTD
Pharmacokinetics (PK) of DRP-104
anticipated 2 year
Disease control rate
Duration of response
Maximum Tolerated Dose (MTD)
Overall Response Rate
Overall survival (OS)
Progression-free survival
anticipated 2 years
Disease Control Rate (DCR)
Overall Response Rate (ORR)
Overall Survival (OS)
Progression-Free Survival (PFS)

Trial Safety

Safety Progress

1 of 3

Trial Design

4 Treatment Groups

Part 2
1 of 4
Part 4
1 of 4
Part 3
1 of 4
Part 1a & Part 1b
1 of 4

Experimental Treatment

246 Total Participants · 4 Treatment Groups

Primary Treatment: DRP-104 · No Placebo Group · Phase 1 & 2

Part 2
Drug
Experimental Group · 1 Intervention: DRP-104 · Intervention Types: Drug
Part 4Experimental Group · 2 Interventions: atezolizumab, DRP-104 · Intervention Types: Biological, Drug
Part 3Experimental Group · 2 Interventions: atezolizumab, DRP-104 · Intervention Types: Biological, Drug
Part 1a & Part 1b
Drug
Experimental Group · 1 Intervention: DRP-104 · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: anticipated 2 year

Who is running the clinical trial?

Dracen Pharmaceuticals, Inc.Lead Sponsor
Sunil Sharma, MDPrincipal InvestigatorHonorHealth Director
8 Previous Clinical Trials
133 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a measurable, advanced or recurrent, histologically or cytologically confirmed, measurable by RECIST 1.1 metastatic or unresectable solid tumor.
You have a performance status of 0 or 1.
Cardiac QTc (Fridericia) <470 ms.
You are a woman of child-bearing potential and you are sexually active.