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ZW251

Phase 1

Hepatocellular Carcinoma | Small molecule | Oncology |Zymeworks Inc.|Last Updated: May 7, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

ZW251 · 1 trial · 3 indications

Phase 1 1
NCT07164313A Study of ZW251 in Participants With Advanced Solid TumorsHepatocellular Carcinoma
RECRUITING100 Analytics
PHASE1RECRUITING
A Study of ZW251 in Participants With Advanced Solid Tumors
Hepatocellular CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of dose-limiting toxicities (DLTs; Part 1)
Up to 3 weeks

Number of participants who experienced a DLT. DLTs include specifically defined adverse events (AEs) considered to be related to ZW251

Incidence of AEs (Parts 1 and 2)
Up to approximately 2 years

Number of participants who experienced AEs, adverse events of special interest, or serious adverse events

Incidence of clinical laboratory abnormalities (Parts 1 and 2)
Up to approximately 2 years

Number of participants who experienced a maximum severity of Grade 3 or higher post-baseline laboratory abnormality, including either hematology or chemistry. Grades are defined using National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE), version 5.0

Objective response rate (Part 2)
Up to approximately 2 years

Number of participants who achieved a best overall response of either confirmed complete response (CR) or partial response (PR) during treatment according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

Secondary Endpoints

Objective response rate (Part 1)
Up to approximately 2 years
Best overall response (Parts 1 and 2)
Up to approximately 2 years
Disease control rate (Parts 1 and 2)
Up to approximately 2 years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ZW251EXPERIMENTAL -

Interventions

NameTypeDescription
ZW251DRUGAdministered intravenously
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites25

Inclusion Criteria: * Pathologically or cytologically confirmed diagnosis of HCC with evidence of locally advanced (unresectable, and ineligible for transplant) and/or metastatic disease. Noninvasive methods may be used to confirm diagnosis * Pathologically or cytologically confirmed diagnosis of s...

Countries:United StatesIrelandJapanPortugalSpainTaiwan
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Frequently asked questions about ZW251

What is ZW251 used for?

ZW251 is an investigational small molecule being developed for the treatment of advanced solid tumors, including hepatocellular carcinoma, squamous cell non-small cell lung cancer, and germ cell tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing ZW251?

ZW251 is being developed by Zymeworks Inc., a biopharmaceutical company traded on the NYSE under the ticker symbol ZYME. The company is conducting clinical trials to evaluate the safety and efficacy of ZW251 in patients with advanced solid tumors.

What phase is ZW251 in?

ZW251 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved for commercial use. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, and preliminary activity in advanced solid tumors.

What clinical trials is ZW251 in?

ZW251 is being studied in a Phase 1 clinical trial registered as NCT07164313, titled "A Study of ZW251 in Participants With Advanced Solid Tumors." The trial is currently recruiting and aims to enroll approximately 100 participants across multiple countries, including the United States, Ireland, Japan, Portugal, Spain, and Taiwan.

Is ZW251 being tested in hepatocellular carcinoma?

Yes, ZW251 is being evaluated in a Phase 1 clinical trial that includes patients with hepatocellular carcinoma, as well as squamous cell non-small cell lung cancer and germ cell tumors. The trial is an open-label, uncontrolled study that is actively recruiting participants aged 18 years and older.