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CX-801

Phase 1

Solid Tumor, Adult | Small molecule | Oncology |CytomX Therapeutics, Inc.|Last Updated: Aug 28, 2026

Target and mechanism

Molecular targetinterferon alpha-2b
Target classCytokine
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment121

FDA Designations

No designations recorded

Clinical trial landscape

CX-801 · 1 trial · 1 indication

Phase 1 1
NCT06462794First In Human Study of CX-801 in Advanced Solid TumorsSolid Tumor, Adult
RECRUITING121 Analytics
PHASE1RECRUITING
First In Human Study of CX-801 in Advanced Solid Tumors
Solid Tumor, AdultUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and tolerability of CX-801 as monotherapy and combination therapy
44 months

The number of participants experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level

Determine the recommended Phase 2 dose (RP2D)
44 months

The number of participants experiencing a dose-limiting toxicity (DLT) as defined in the protocol, AEs (adverse events), and treatment-emergent adverse events (TEAEs) at any dose level

Secondary Endpoints

Objective response rate (ORR)
60 months
Duration of response (DOR)
60 months
Progression-free survival (PFS)
60 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CX-801EXPERIMENTAL -
CX-801 + pembrolizumabEXPERIMENTAL -

Interventions

NameTypeDescription
CX-801DRUGInvestigational drug
pembrolizumabDRUGStandard of Care Therapy
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Eligibility Criteria

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

Inclusion Criteria: * Metastatic or locally advanced unresectable solid tumor that has progressed after standard therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Measurable disease per RECIST v1.1 * Consent to fresh biopsy or if medically contraindicated, recent (with...

Countries:United States
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Recent Changes (Last 90 Days)

LOWAug 28, 2026NCT06462794lastUpdatePostDate: changed
LOWAug 28, 2026NCT06462794lastUpdatePostDate: changed
LOWJun 29, 2026NCT06462794lastUpdatePostDate: changed
LOWJun 29, 2026NCT06462794lastUpdatePostDate: changed

Frequently asked questions about CX-801

What is CX-801 used for in solid tumors?

CX-801 is an investigational small molecule being developed for the treatment of solid tumors in adults. It is currently in Phase 1 clinical development, with an ongoing first-in-human study evaluating its safety and efficacy in patients with advanced solid tumors.

What does CX-801 target?

CX-801 targets interferon alpha-2b, a cytokine involved in immune signaling. By modulating this target, the drug aims to exert anti-tumor effects in solid tumors. It is being studied in a Phase 1 clinical trial for adult patients with advanced solid tumors.

Who makes CX-801?

CX-801 is being developed by CytomX Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol CTMX. The company is conducting a Phase 1 clinical trial of CX-801 in patients with advanced solid tumors.

What phase is CX-801 in?

CX-801 is in Phase 1 clinical development. It is an investigational drug, not yet approved by regulatory authorities, and is being studied in a first-in-human trial for advanced solid tumors in adults. The trial is currently recruiting participants in the United States.

What clinical trials is CX-801 in?

CX-801 is being evaluated in a Phase 1 clinical trial with the identifier NCT06462794, titled 'First In Human Study of CX-801 in Advanced Solid Tumors.' This single-arm, controlled study is recruiting 121 adult patients with solid tumors in the United States.

Is CX-801 the same as interferon alpha-2b?

CX-801 is not the same as interferon alpha-2b; rather, it targets interferon alpha-2b. As a small molecule, CX-801 is designed to interact with this cytokine target, which is part of its mechanism of action in treating solid tumors. It is currently in Phase 1 clinical trials.