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Checkpoint Inhibitor

DRP-104 for Solid Tumors

Phase 1 & 2

Waitlist Available

Led By Sunil Sharma, MD

Research Sponsored by Dracen Pharmaceuticals, 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 anticipated 2 year

Awards & highlights

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
Non-Small Cell Lung Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ anticipated 2 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~anticipated 2 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and anticipated 2 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Cmax of DRP-104

Maximum Tolerated Dose (MTD)

Overall Response Rate (ORR)

+1 more

Secondary outcome measures

Disease Control Rate (DCR)

Overall Survival (OS)

Progression-Free Survival (PFS)

Trial Design

4Treatment groups

Experimental Treatment

Group I: Part 4Experimental Treatment2 Interventions

Phase 1 combination safety expansion at the MTD/MAD/RP2D, route, and schedule of administration of DRP-104 with atezolizumab in a similar patient population as the dose-escalation (N=14 patients).

Group II: Part 3Experimental Treatment2 Interventions

Phase 1 combination dose escalation of DRP-104 and atezolizumab in patients with advanced solid tumors (excluding primary CNS tumors and HCC) previously treated with an agent targeting checkpoint pathway inhibition (such as anti-PD-1, anti-PD-L1, and/or anti-CTLA-4 antibody), starting one dose level below the MTD/MAD/RP2D (MTD-1) of the recommended phase 2 route and schedule of administration of singleagent DRP-104 and in combination with 1200 mg atezolizumab administered via intravenous infusion on day 1 and repeated every 3 weeks (up to approximately 12 patients);

Group III: Part 2Experimental Treatment1 Intervention

Cohort 1: Phase 1 single-agent safety expansion of DRP-104 administered subQ (the RP2R) in patients with advanced solid tumors (excluding primary CNS tumors and HCC). DRP-104 will be administered twice weekly subQ in this safety expansion at the twice weekly subQ MTD/MAD/RP2D of DRP-104 determined in Part 1-Cohort 1b. A minimum of 14 and up to 20 patients will be enrolled. Cohort 2: Phase 2a expansion at the MTD/MAD/RP2D/RP2R and schedule of administration (subQ twice or thrice weekly) of DRP-104 in patients with locally advanced or metastatic NSCLC whose tumors contain a known mutation in kelchlike ECH-associated protein 1 (KEAP1), nuclear factor erythroid 2-related factor 2 (NFE2L2) and/or serine/threonine kinase 11 (STK11), (N=55). If the thrice weekly schedule is selected as the RP2S, a safety review will be conducted after 8 patients have enrolled and are followed for at least one cycle of treatment before additional patients are enrolled into Part 2-Cohort 2.

Group IV: Part 1a & Part 1bExperimental Treatment1 Intervention

Single-agent dose escalation of DRP-104 to define the MTD (up to approximately 50 patients) starting at Dose Level 1 of 3.3 mg/m2 via intravenous injection Single-agent dose escalation of DRP-104 to define the MTD (up to approximately 50 patients) starting at Dose Level 1 at 10 mg via subcutaneous injection

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dracen Pharmaceuticals, Inc.Lead Sponsor

1 Previous Clinical Trials

27 Total Patients Enrolled

Sunil Sharma, MDPrincipal InvestigatorHonorHealth Director

8 Previous Clinical Trials

133 Total Patients Enrolled

Frequently Asked Questions

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

How geographically widespread is the current medical experiment in this state?

"Currently, 14 different locations are allowing patients to join this research. These cities include Orlando, Columbus and Kissimmee among others. If you choose to become involved with the trial it may be beneficial to select a close clinical site in order to reduce travel needs."

Answered by AI

To what extent have other investigations explored the effects of DRP-104?

"The initial clinical trial of DRP-104 was conducted at SCRI Tennessee Oncology Chattanooga in 2008. Since then, 80 studies have concluded and 350 are currently recruiting. Notably, there is a high concentration of these trials running from Orlando, Florida."

Answered by AI

Has this experiment ever been attempted before?

"DRP-104 is being studied in 350 active clinical trials, spread out over 74 countries and 1646 cities. The first trial for DRP-104 began in 2008 under the auspices of Hoffmann-La Roche with 720 participants; since then, 80 additional studies have concluded."

Answered by AI

How many people have enrolled in this research initiative?

"246 eligible volunteers must enroll in this research trial. Citizens of Florida and Ohio have the opportunity to take part, with sites at Florida Cancer Specialist (Orlando) and Ohio State University Comprehensive Cancer Centre (Columbus)."

Answered by AI

What is the traditional purpose of DRP-104?

"DRP-104 has shown promise in treating adverse conditions like small cell lung cancer, malignant neoplasms, and non-small cell carcinoma."

Answered by AI

Is this medical research effort currently accruing participants?

"As per the clinicaltrials.gov listing, this trial has been open to recruitment since August 31st 2020 and was recently modified on November 29th 2022. The study is actively seeking participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study to Investigate DRP-104 in Adults With Advanced Solid Tumors

2020. "Study to Investigate DRP-104 in Adults With Advanced Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04471415.