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CYAD-101

Phase 1

Unresectable Metastatic Colorectal Cancer | Small molecule | Oncology |Merck & Company, Inc.|Last Updated: Mar 9, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment34

FDA Designations

No designations recorded

Clinical trial landscape

CYAD-101 · 1 trial · 1 indication

Phase 1 1
NCT04991948Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal CancerUnresectable Metastatic Colorectal Cancer
RECRUITING34 Analytics
PHASE1RECRUITING
Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer
Unresectable Metastatic Colorectal CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

The Occurrence of Dose Limiting Toxicities (DLT) during the 'DLT reporting period'
Up to 73 days post first study treatment administration

The occurrence of DLT during the 'DLT reporting period' is defined as the period from study enrollment on D1 (Visit 1) up to 3 weeks after first pembrolizumab treatment on D73 (Visit 14).

The objective response rate (ORR) at the tumor assessment on Day 94 [Visit 15])
Up to 94 days post first study treatment administration

The objective response rate (ORR) at the tumor assessment on Day 94 \[Visit 15\]), 6 weeks after the first pembrolizumab treatment administration.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CYAD-101 with FOLFOX Infusion administered concurrently followed by pembrolizumabEXPERIMENTAL -

Interventions

NameTypeDescription
CYAD-101DRUGAllogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
FOLFOXDRUG5-FU, leucovorin and oxaliplatin
PembrolizumabDRUGHumanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites5

Key Inclusion Criteria: 1. Histologically proven metastatic adenocarcinoma of the colon or rectum. 1. Confirmed metastatic unresectable adenocarcinoma of the colon or the rectum. 2. Confirmed non-microsatellite instability high (non-MSI-H)/mismatch-repair proficient (pMMR) tumor status 3....

Countries:United StatesBelgium
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Frequently asked questions about CYAD-101

What is CYAD-101 used for?

CYAD-101 is being studied for the treatment of unresectable metastatic colorectal cancer. It is an investigational small molecule therapy currently in Phase 1 clinical development. The drug is being evaluated in combination with other treatments to assess its safety and efficacy in patients with this advanced form of colorectal cancer.

Who makes CYAD-101?

CYAD-101 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. Merck is conducting clinical trials to evaluate the safety and effectiveness of this investigational drug for the treatment of unresectable metastatic colorectal cancer.

What phase is CYAD-101 in?

CYAD-101 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied in clinical trials. The ongoing Phase 1 trial is recruiting participants to evaluate the drug's safety, tolerability, and preliminary efficacy in patients with unresectable metastatic colorectal cancer.

What clinical trials is CYAD-101 in?

CYAD-101 is being studied in a Phase 1 clinical trial with the identifier NCT04991948. This trial is titled 'Study of Pembrolizumab Treatment After CYAD-101 With FOLFOX Preconditioning in Metastatic Colorectal Cancer' and is currently recruiting participants in the United States and Belgium. The trial aims to enroll 34 patients with unresectable metastatic colorectal cancer.

Is CYAD-101 being tested in a randomized controlled trial?

No, the ongoing clinical trial of CYAD-101 is not randomized and does not use a control group. It is an uncontrolled, open-label study, meaning all participants receive the investigational treatment. The trial is also not double-blinded, as both researchers and participants are aware of the treatment being administered.