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BLYG8824A

Phase 1

Colorectal Cancer | Small molecule | Oncology |Roche Holding AG|Last Updated: Apr 25, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment46

FDA Designations

No designations recorded

Clinical trial landscape

BLYG8824A · 1 trial · 1 indication

Phase 1 1
NCT04468607A Study of BLYG8824A in Participants With Locally Advanced or Metastatic Colorectal CancerColorectal Cancer
COMPLETED46 Analytics
PHASE1COMPLETED
A Study of BLYG8824A in Participants With Locally Advanced or Metastatic Colorectal Cancer
Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence and Nature of DLTs
Approximately 48 months
Number of Patricipants with Adverse Events
Approximately 48 months
Number Of Cycles Received
Approximately 48 months
Dose Intensity
Approximately 48 months
Maximum Tolerated Dose(s) MTD(s) of BLYG8824A
Approximately 48 months

Secondary Endpoints

Serum Concentration of BLYG8824A
At predifined interevals from Cycle 1 Day 1; Cycle 2 Day 1; Cycles ≥ 3, Day 1; Treatment Completion/ Discontinuation (Cycle length: 21 days)
Overall Response Rate (ORR)
Approximately 48 months
Duration of Response (DOR)
Approximately 48 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose-Escalation StageEXPERIMENTALParticipants will be assigned sequentially to escalating doses of BLYG8824A, up to the maximum tolerated dose (MTD).
Dose-Expansion StageEXPERIMENTALOnce dose escalation is completed and the MTD (or MAD) has been identified, a recommended expansion dose will be proposed for the dose-expansion stage of the trial.

Interventions

NameTypeDescription
BLYG8824ADRUGBLYG8824A will be administered at a flat dose independent of body weight.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * ECOG performance status of 0 or 1 * Life expectancy of at least 12 weeks * Histologically or cytologically documented invasive CRC: incurable, unresectable, locally advanced or metastatic CRC previously treated with multimodality therapy or mCRC * Locally advanced or metastati...

Countries:United StatesAustraliaSpain
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Frequently asked questions about BLYG8824A

What is BLYG8824A used for?

BLYG8824A is an investigational small molecule being studied for the treatment of colorectal cancer. It is being evaluated in patients with locally advanced or metastatic colorectal cancer. The drug is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes BLYG8824A?

BLYG8824A is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug.

What phase is BLYG8824A in?

BLYG8824A is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies for commercial use. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing.

What clinical trials is BLYG8824A in?

BLYG8824A has been studied in one clinical trial registered as NCT04468607, titled "A Study of BLYG8824A in Participants With Locally Advanced or Metastatic Colorectal Cancer." This Phase 1 trial enrolled 46 participants and was conducted in the United States, Australia, and Spain. The trial has been completed.

Is BLYG8824A FDA approved?

BLYG8824A is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed Phase 1 trial evaluated the drug in patients with colorectal cancer, but further clinical studies would be needed before any regulatory approval could be considered.