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RO6895882

Phase 1

Neoplasms | Small molecule | Oncology |Roche Holding AG|Last Updated: Mar 6, 2018

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment110

FDA Designations

No designations recorded

Clinical trial landscape

RO6895882 · 1 trial · 1 indication

Phase 1 1
NCT02004106A Study to Evaluate Safety, Pharmacokinetics, and Efficacy of RO6895882 in Participants With Advanced and/or Metastatic Solid TumorsNeoplasms
COMPLETED110 Analytics
PHASE1COMPLETED
A Study to Evaluate Safety, Pharmacokinetics, and Efficacy of RO6895882 in Participants With Advanced and/or Metastatic Solid Tumors
NeoplasmsUnlock trial analytics

Study Endpoints

Primary Endpoints

Part 2: Percentage of Participants With Dose-Limiting Toxicity (DLT)
Part 2: within 21 days after the highest dose administration
Part 2: MTD of RO6895882
Part 2: within 21 days after the highest dose administration
Percentage of Participants With Adverse Events
Day 1 up to 28 days after last dose of study drug (up to approximately 25 months)
Percentage of Participants With Anti-drug Antibodies (ADAs) Against RO6895882
Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)

Part 1: Predose (Hour \[Hr\] 0). Part 2/3: qw schedule (1 cycle = 1 week): Predose in Cycle 1, 4, 5, 6, thereafter every 2 months; Part 2/3: q2w schedule (1 cycle = 2 weeks): Predose in Cycle 1, 4, 6, thereafter every 8 weeks. Part 2/3: q3w schedule (1 cycle = 3 weeks): Predose in Cycle 1, 2, 3, 4, 6, thereafter every 9 weeks. Additionally at treatment discontinuation or at 28-days after last dose (up to approximately 25 months)

Area Under the Serum Concentration-Time Curve (AUC) of RO6895882
Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)

Predose (Hr 0), 1 hr post start of infusion (SoI), at end of infusion (EoI), 2, 4, 24, 72, 96, 216 hrs post Day 1 dose. Part 2/3: qw schedule (1 cycle = 1 week): Predose, 1 hr post SoI, at EoI, 2, 4 hrs after EoI, 24, 72, 96 hrs postdose in Cycle 1, 5 (include 120 hrs postdose); Predose, 24, 96 hrs postdose in Cycle 2, 3, 4; Predose in any later cycle. Part 2/3: q2w schedule (1 cycle = 2 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 1, 4 (exclude 312 hrs postdose); Predose, 24, 96, 168 hrs postdose in Cycle 2; Predose in all later cycles. Part 2/3: q3w schedule (1 cycle = 3 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312, 480 hrs postdose in Cycle 1; Predose, 24, 96, 312 hrs postdose in Cycle 2; Predose, at EoI, 1, 2, 4 hrs post EoI, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 3; Predose, 24, 72, 120, 312 hrs postdose in Cycle 4; Predose in all later cycles. Maximum infusion length = 2 hrs.

Minimum Observed Serum Concentration (Cmin) of RO6895882
Part 1/2/3: Predose (Hr 0) in all cycles (maximum up to 25 months) (cycle length = 1, 2, or 3 weeks, respectively)
Maximum Observed Serum Concentration (Cmax) of RO6895882
Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)

Part 1: Predose (Hr 0), 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 216 hrs post Day 1 dose. Part 2/3: qw schedule (1 Cycle = 1 week): Predose, 1 hr post SoI, at EoI, 2, 4 hrs after EoI, 24, 72, 96 hrs postdose in Cycle 1, 5 (include 120 hrs postdose); Predose, 24, 96 hrs postdose in Cycle 2, 3, 4; Predose in any later cycle. Part 2/3: q2w schedule (1 Cycle = 2 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 1, 4 (exclude 312 hrs postdose); Predose, 24, 96, 168 hrs postdose in Cycle 2; Predose in all later cycles. Part 2/3: q3w schedule (1 Cycle = 3 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312, 480 hrs postdose in Cycle 1; Predose, 24, 96, 312 hrs postdose in Cycle 2; Predose, at EoI, 1, 2, 4 hrs post EoI, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 3; Predose, 24, 72, 120, 312 hrs postdose in Cycle 4; Predose in all later cycles. Maximum infusion length = 2 hrs.

Clearance (CL) of RO6895882
Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)

Part 1: Predose (Hr 0), 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 216 hrs post Day 1 dose. Part 2/3: qw schedule (1 Cycle = 1 week): Predose, 1 hr post SoI, at EoI, 2, 4 hrs after EoI, 24, 72, 96 hrs postdose in Cycle 1, 5 (include 120 hrs postdose); Predose, 24, 96 hrs postdose in Cycle 2, 3, 4; Predose in any later cycle. Part 2/3: q2w schedule (1 Cycle = 2 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 1, 4 (exclude 312 hrs postdose); Predose, 24, 96, 168 hrs postdose in Cycle 2; Predose in all later cycles. Part 2/3: q3w schedule (1 Cycle = 3 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312, 480 hrs postdose in Cycle 1; Predose, 24, 96, 312 hrs postdose in Cycle 2; Predose, at EoI, 1, 2, 4 hrs post EoI, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 3; Predose, 24, 72, 120, 312 hrs postdose in Cycle 4; Predose in all later cycles. Maximum infusion length = 2 hrs.

Volume of Distribution at Steady State (Vss) of RO6895882
Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)

Part 1: Predose (Hr 0), 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 216 hrs post Day 1 dose. Part 2/3: qw schedule (1 Cycle = 1 week): Predose, 1 hr post SoI, at EoI, 2, 4 hrs after EoI, 24, 72, 96 hrs postdose in Cycle 1, 5 (include 120 hrs postdose); Predose, 24, 96 hrs postdose in Cycle 2, 3, 4; Predose in any later cycle. Part 2/3: q2w schedule (1 Cycle = 2 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 1, 4 (exclude 312 hrs postdose); Predose, 24, 96, 168 hrs postdose in Cycle 2; Predose in all later cycles. Part 2/3: q3w schedule (1 Cycle = 3 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312, 480 hrs postdose in Cycle 1; Predose, 24, 96, 312 hrs postdose in Cycle 2; Predose, at EoI, 1, 2, 4 hrs post EoI, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 3; Predose, 24, 72, 120, 312 hrs postdose in Cycle 4; Predose in all later cycles. Maximum infusion length = 2 hrs.

Half-life (t1/2) of RO6895882
Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)

Part 1: Predose (Hr 0), 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 216 hrs post Day 1 dose. Part 2/3: qw schedule (1 Cycle = 1 week): Predose, 1 hr post SoI, at EoI, 2, 4 hrs after EoI, 24, 72, 96 hrs postdose in Cycle 1, 5 (include 120 hrs postdose); Predose, 24, 96 hrs postdose in Cycle 2, 3, 4; Predose in any later cycle. Part 2/3: q2w schedule (1 Cycle = 2 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 1, 4 (exclude 312 hrs postdose); Predose, 24, 96, 168 hrs postdose in Cycle 2; Predose in all later cycles. Part 2/3: q3w schedule (1 Cycle = 3 weeks): Predose, 1 hr post SoI, at EoI, 2, 4, 24, 72, 96, 120, 168, 312, 480 hrs postdose in Cycle 1; Predose, 24, 96, 312 hrs postdose in Cycle 2; Predose, at EoI, 1, 2, 4 hrs post EoI, 24, 72, 96, 120, 168, 312 hrs postdose in Cycle 3; Predose, 24, 72, 120, 312 hrs postdose in Cycle 4; Predose in all later cycles. Maximum infusion length = 2 hrs.

Secondary Endpoints

Count of Cluster of Differentiation (CD) 4+ Cells Analyzed by Flow Cytometry
Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Count of CD8+ Cells Analyzed by Flow Cytometry
Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
Count of B Lymphocyte Cells Analyzed by Flow Cytometry
Baseline up to 28-days after last dose (up to approximately 25 months) (please see outcome measure description for detailed time frame)
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: RO6895882 Single Ascending DoseEXPERIMENTALParticipants will receive RO6895882 at ascending doses (\</= 6 mg) as a single intravenous (IV) infusion.
Part 2: RO6895882 Dose Escalation MonotherapyEXPERIMENTALParticipants in different cohorts will receive RO6895882 at ascending doses as IV infusion qw, q2w or q3w. After completion of Part 2 all participants have the option to receive the recommended RO6895882 dose once defined in Part 2 at the discretion of investigator.
Part 3: RO6895882 MTD ExpansionEXPERIMENTALParticipants will receive RO6895882 at MTD determined in Part 2 as IV infusion qw, q2w or q3w.

Interventions

NameTypeDescription
RO6895882DRUGParticipants will receive RO6895882 at different dose levels and schedules defined in respective arms as IV infusion.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: * Participants with confirmed advanced and/or metastatic solid tumor, with at least one tumor lesion of non-critical location accessible to biopsy who have progressed on the standard of care therapy * Locally confirmed CEA expression in tumor tissue (more than \[\>\] 20 percent ...

Countries:United StatesDenmarkFinlandFranceNetherlandsSpainSwitzerlandUnited Kingdom
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Frequently asked questions about RO6895882

What is RO6895882 used for?

RO6895882 is an investigational small molecule being studied for the treatment of neoplasms, which are abnormal growths of tissue that can be benign or malignant. It is being evaluated in patients with advanced and/or metastatic solid tumors as part of a Phase 1 clinical trial.

Who makes RO6895882?

RO6895882 is being developed by Roche Holding AG, a multinational healthcare company. Roche is conducting clinical research on this investigational oncology drug candidate.

What phase is RO6895882 in?

RO6895882 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in clinical trials.

What clinical trials is RO6895882 in?

RO6895882 has been studied in one clinical trial, identified as NCT02004106. This was a Phase 1 study evaluating the safety, pharmacokinetics, and efficacy of RO6895882 in participants with advanced and/or metastatic solid tumors. The trial has been completed.

Is RO6895882 the same as any other drug?

RO6895882 is the specific drug candidate identifier used by Roche for this investigational compound. No alternative names have been established for this drug in public clinical trial records.