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Evofosfamide

Phase 1

Metastatic Prostate Cancer | Small molecule | Oncology |Agenus Inc.|Last Updated: Jan 21, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment71

FDA Designations

No designations recorded

Clinical trial landscape

Evofosfamide · 1 trial · 3 indications

Phase 1 1
NCT06782555A Study of Evofosfamide in Combination with Zalifrelimab and BalstilimabMetastatic Prostate Cancer
RECRUITING71 Analytics
PHASE1RECRUITING
A Study of Evofosfamide in Combination with Zalifrelimab and Balstilimab
Metastatic Prostate CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence and severity of adverse events including dose-limiting toxicities
12 months

Secondary Endpoints

Serious adverse events, discontinuations, and deaths
12 months
Progression-free survival per RECIST 1.1 and iRECIST
12 months
Objective response rate per RECIST 1.1 and iRECIST criteria (or PCWG3/RECIST for prostate cancer)
12 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Castration-resistant prostate cancerEXPERIMENTALEvofosfamide + zalifrelimab + balstilimab
Pancreatic cancerEXPERIMENTALEvofosfamide + zalifrelimab + balstilimab
Human papilloma virus-negative squamous cell carcinoma of the head and neckEXPERIMENTALEvofosfamide + zalifrelimab + balstilimab

Interventions

NameTypeDescription
EvofosfamideDRUGEvofosfamide administered on Days 1 and 8 of Cycles 1, 2, and 3.
ZalifrelimabDRUGZalifrelimab administered on Day 8 of Cycles 1, 3, and 5.
BalstilimabDRUGBalstilimab administered every 2 weeks beginning on Day 8 of Cycle 1.
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Eligibility Criteria

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

Inclusion Criteria: 1. Histologically confirmed locally advanced or metastatic castration-resistant prostate cancer, pancreatic cancer, or HPV-negative SCCHN for which no other lines of standard therapy with demonstrated clinical benefit are available or appropriate as treatment. 2. Appropriate to ...

Countries:United States
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Competitive Landscape -Prostate Cancer 254 trials (matched to "Metastatic Prostate Cancer")

Frequently asked questions about Evofosfamide

What is Evofosfamide used for?

Evofosfamide is an investigational small molecule being studied for the treatment of metastatic prostate cancer. It is also being evaluated in metastatic head and neck squamous cell carcinoma and metastatic pancreatic cancer. The drug is currently in Phase 1 clinical development.

Who makes Evofosfamide?

Evofosfamide is being developed by Agenus Inc., a biopharmaceutical company. Agenus is listed on the stock exchange under the ticker symbol AGEN. The company is conducting clinical trials to evaluate the safety and efficacy of Evofosfamide in various cancer indications.

What phase is Evofosfamide in?

Evofosfamide is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to study the drug in combination with other agents for the treatment of certain metastatic cancers.

What clinical trials is Evofosfamide in?

Evofosfamide is being studied in a Phase 1 clinical trial with the identifier NCT06782555. This trial is evaluating Evofosfamide in combination with Zalifrelimab and Balstilimab in patients with metastatic prostate cancer, metastatic head and neck squamous cell carcinoma, and metastatic pancreatic cancer. The trial is currently recruiting participants in the United States.

How does Evofosfamide work?

The specific molecular target of Evofosfamide is not disclosed in the available information. As a small molecule, it is being investigated for its potential anti-cancer activity. The ongoing clinical trial is studying its effects in combination with other therapies, but the exact mechanism of action has not been detailed.