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Study of DCC-2812 in Participants With Advanced Genitourinary Cancers

ConditionsRenal Cell CarcinomaUrothelial CarcinomaCastration-resistant Prostate Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorDeciphera Pharmaceuticals, LLC

About this trial

This is a multicenter clinical trial to evaluate the safety and preliminary activity of the selective general control nonderepressible 2 (GCN2) activator DCC-2812 as monotherapy in advanced/metastatic renal cell carcinoma (RCC), urothelial carcinoma, and castration-resistant prostate cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have confirmed Advanced or Metastatic Renal Cell Carcinoma, Urothelial Cancer, or Castration-Resistant Prostate Cancer

Able to take oral medication

If a female is of childbearing potential, must have a negative pregnancy test prior to enrollment and all participants agree to follow the contraception requirements

Adequate organ function and electrolytes

Disqualifiers

Received any prior anticancer therapy or any investigational therapy within a specified timeframe prior to first dose of DCC-2812

Impaired cardiac function

Major surgery within 28 days of the first dose of study drug

Trial design

Design model

Single group

Treatments tested in this trial

  • DCC-2812

    Drug

    Administered orally

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: DCC-2812Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Dose-limiting Toxicities (DLTs)

Time frame
Cycle 1 (28 days)
2

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Time frame
Up to 42 months
3

Number of Participants With Dose Reduction, Interruption, or Discontinuation of Study Drug Due to TEAEs

Time frame
Up to 42 months

Secondary outcomes

1

Radiographic Objective Response Rate (rORR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1

Time frame
Up to 42 months
2

Radiographic Duration of Response (rDOR) per RECIST v1.1

Time frame
Up to 42 months
3

PK: Maximum Observed Plasma Drug Concentration (Cmax)

Time frame
Predose up to 24 hours postdose (up to 42 months)
4

PK: Time to Reach Cmax (Tmax)

Time frame
Predose up to 24 hours postdose (up to 42 months)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Deciphera Pharmaceuticals, LLC

Lead sponsor

Source ClinicalTrials.gov
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