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Cobimetinib

Phase 1

Locally Advanced Pancreatic Ductal Adenocarcinoma | Small molecule | Oncology |Cardiff Oncology, Inc.|Last Updated: Sep 4, 2026

Target and mechanism

Molecular targetMAP2K1, MAP2K2
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment90

FDA Designations

No designations recorded

Clinical trial landscape

Cobimetinib · 1 trial · 8 indications

Early Phase 1 1
NCT04005690Targeted Pathway Inhibition in Patients With Pancreatic CancerLocally Advanced Pancreatic Ductal Adenocarcinoma
RECRUITING90 Analytics
EARLY_PHASE1RECRUITING
Targeted Pathway Inhibition in Patients With Pancreatic Cancer
Locally Advanced Pancreatic Ductal AdenocarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Proportion of all pharmacodynamic feasibility-evaluable participants within a study arm that have a measurable change in post-treatment tumor biology from baseline
Changes in tumor biology from baseline (i.e., Day 0) and on-treatment biopsy (i.e., 10 days from start of study intervention)

Will be estimated with a 95% confidence interval (CI).

Secondary Endpoints

Incidence of >= grade 3 toxicities for each assigned window treatment (as described in sub-protocol)
Up to 30 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm OlaparibEXPERIMENTALPatients receive olaparib PO BID on days 1-10 in the absence of disease progression or unacceptable toxicity. Within 12-24 hours, patients undergo biopsy or surgery as clinically appropriate per institutional standards for management of patient's disease. (Arm Closed as of 8/12/2024)
Arm CobimetinibEXPERIMENTALPatients receive cobimetinib PO QD on days 1-10 in the absence of disease progression or unacceptable toxicity. Within 12-24 hours, patients undergo biopsy or surgery as clinically appropriate per institutional standards for management of patient's disease. (Arm Closed as of 8/12/2024)
Arm OnvansertibEXPERIMENTALPatients receive onvansertib PO QD on days 1-10 in the absence of disease progression or unacceptable toxicity. Within 12-24 hours, patients undergo biopsy or surgery as clinically appropriate per institutional standards for management of patient's disease. (Arm Closed as of 8/12/2024)
Arm AzenosertibEXPERIMENTALPatients receive azenosertib PO QD on days 1-10 in the absence of disease progression or unacceptable toxicity. Within 12-24 hours, patients undergo biopsy or surgery as clinically appropriate per institutional standards for management of patient's disease.
Arm AZD5305EXPERIMENTALPatients receive AZD5305 PO QD on days 1-10 in the absence of disease progression or unacceptable toxicity. Within 12-24 hours, patients undergo biopsy or surgery as clinically appropriate per institutional standards for management of patient's disease.
Arm TremelimumabEXPERIMENTALPatients receive tremelimumab IV over 60 minutes one-time. Within 12-24 hours of cycle completion, patients undergo biopsy or surgery as clinically appropriate per institutional standards for management of patient's disease.

Interventions

NameTypeDescription
CobimetinibDRUGGiven PO
OlaparibDRUGGiven PO
OnvansertibDRUGGiven PO
AzenosertibDRUGGiven PO
SaruparibDRUGGiven PO
TremelimumabBIOLOGICALGiven IV
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Ability to understand and the willingness to sign a written informed consent document * Age \>= 18 years * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 * Clinically-confirmed diagnosis of resectable, borderline resectable, locally-advanced or metastatic ...

Countries:United States
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Recent Changes (Last 90 Days)

MEDIUMSep 4, 2026NCT04005690primaryCompletionDate: changed

Frequently asked questions about Cobimetinib

What is Cobimetinib used for in locally advanced pancreatic ductal adenocarcinoma?

Cobimetinib is being studied for use in locally advanced pancreatic ductal adenocarcinoma, as well as metastatic, stage II, III, and IV pancreatic cancer, and resectable, borderline resectable, and unresectable pancreatic ductal adenocarcinoma. It is an investigational small molecule kinase inhibitor in Phase 1 clinical development.

What does Cobimetinib target?

Cobimetinib is a small molecule that belongs to the -tinib class of kinase inhibitors. It is being investigated for its ability to inhibit specific kinase pathways involved in cancer cell growth and survival, particularly in pancreatic ductal adenocarcinoma.

Who makes Cobimetinib?

Cobimetinib is being developed by Cardiff Oncology, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CRDF. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with pancreatic cancer.

What phase is Cobimetinib in?

Cobimetinib is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing trial is an early Phase 1 study that is currently recruiting participants in the United States.

What clinical trials is Cobimetinib in?

Cobimetinib is being evaluated in clinical trial NCT04005690, titled "Targeted Pathway Inhibition in Patients With Pancreatic Cancer." This early Phase 1 study is recruiting 90 participants with various stages of pancreatic ductal adenocarcinoma in the United States, with a minimum age of 18 years.

Is Cobimetinib the same as Cotellic?

Cobimetinib is the generic name for the drug also known as Cotellic. In the context of this development program, Cardiff Oncology is investigating cobimetinib for pancreatic cancer, though the drug is also known by its brand name in other settings.