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Checkpoint Inhibitor

Study to Investigate DRP-104 in Adults With Advanced 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

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial tests DRP-104, a new cancer drug, alone and with atezolizumab, an immune-boosting drug, in patients with advanced solid tumors, especially those with specific genetic mutations. DRP-104 aims to kill cancer cells directly, while atezolizumab helps the immune system fight the cancer.

Eligible Conditions

Advanced Solid Tumors
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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cmax of DRP-104

Maximum Tolerated Dose (MTD)

Overall Response Rate (ORR)

+1 more

Secondary study objectives

Disease Control Rate (DCR)

Overall Survival (OS)

Progression-Free Survival (PFS)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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