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DCDS0780A

Phase 1

Non-Hodgkin's Lymphoma | Small molecule | Oncology |Roche Holding AG|Last Updated: Aug 29, 2019

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment66

FDA Designations

No designations recorded

Clinical trial landscape

DCDS0780A · 1 trial · 1 indication

Phase 1 1
NCT02453087A Study of Escalating Doses of DCDS0780A in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's LymphomaNon-Hodgkin's Lymphoma
COMPLETED66 Analytics
PHASE1COMPLETED
A Study of Escalating Doses of DCDS0780A in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma
Non-Hodgkin's LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants with Adverse Events
Baseline up to 30 days after the last dose of study drug (up to 1 year)
Percentage of Participants with Dose-Limiting Toxicities
Days 1 to 21
Maximum Tolerated Dose (MTD) of DCDS0780A
Days 1 to 21
Recommended Phase 2 Dose (RP2D) of DCDS0780A
Days 1 to 21

Secondary Endpoints

Area Under the Serum Concentration-Time Curve (AUC) for DCDS0780A Total Antibody
Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)
Maximum Observed Serum Concentration (Cmax) for DCDS0780A Total Antibody
Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)
Total Clearance (CL) of DCDS0780A Total Antibody
Pre-infusion on Cycle 1 Day 1 up to 1 year (detailed timeframe is provided in outcome description section)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
DCDS0780A MonotherapyEXPERIMENTALParticipants will receive escalating doses of DCDS0780A as intravenous infusion as monotherapy on Day 1 of each 21-day cycle up to approximately 1 year or until disease progression or unacceptable toxicity (whichever comes first).
DCDS0780A + RituximabEXPERIMENTALParticipants will receive escalating doses of DCDS0780A on Day 2 of Cycles 1 and 2, and from Cycle 3 onwards on Day 1 of each 21-day cycle in combination with rituximab at a dose of 375 milligrams per square meter (mg/m\^2) of body surface area as intravenous infusion on Day 1 of each 21-day cycle up to approximately 1 year or until disease progression or unacceptable toxicity (whichever comes first).
DCDS0780A + ObinutuzumabEXPERIMENTALParticipants will receive escalating doses of DCDS0780A on Day 2 of Cycles 1 and 2, and from Cycle 3 onwards on Day 1 of each 21-day cycle in combination with obinutuzumab at a dose of 1000 milligrams (mg) as intravenous infusion on Days 1, 8, and 15 of Cycle 1, and from Cycle 2 onwards on Day 1 of each 21-day cycle up to approximately 1 year or until disease progression or unacceptable toxicity (whichever comes first).

Interventions

NameTypeDescription
DCDS0780ADRUGParticipants will receive escalating doses of DCDS0780A as intravenous infusion.
RituximabDRUGParticipants will receive rituximab at a dose of 375 mg/m\^2 of body surface area as intravenous infusion.
ObinutuzumabDRUGParticipants will receive obinutuzumab at a dose of 1000 milligrams (mg) as intravenous infusion.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * Life expectancy of at least 12 weeks * Histologically confirmed B-cell non-Hodgkin's lymphoma that has relapsed after or failed to respond to at least one prior treatment regimen and for which no suitable therapy of curative intent or higher priority exists * A clinical indica...

Countries:United States
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Frequently asked questions about DCDS0780A

What is DCDS0780A used for?

DCDS0780A is an investigational small molecule being studied for the treatment of Non-Hodgkin's Lymphoma, specifically in patients with relapsed or refractory B-cell Non-Hodgkin's Lymphoma. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who makes DCDS0780A?

DCDS0780A is being developed by Roche Holding AG, a biopharmaceutical company traded on the OTC market under the ticker RHHBY. Roche is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with Non-Hodgkin's Lymphoma.

What phase is DCDS0780A in?

DCDS0780A is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies. The Phase 1 trial has been completed, and the drug is no longer in active clinical trials.

What clinical trials is DCDS0780A in?

DCDS0780A has been studied in one clinical trial, identified as NCT02453087. This was a Phase 1 study of escalating doses of DCDS0780A in participants with relapsed or refractory B-cell Non-Hodgkin's Lymphoma. The trial was conducted in the United States and has been completed.

What does DCDS0780A target?

The specific molecular target of DCDS0780A has not been disclosed in available information. It is classified as a small molecule therapeutic agent, but its mechanism of action in treating Non-Hodgkin's Lymphoma has not been publicly detailed.