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ADI-270

Phase 1

Clear Cell Renal Cell Carcinoma | Small molecule | Oncology |Adicet Bio, Inc.|Last Updated: Aug 15, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

FAST_TRACK

Clinical trial landscape

ADI-270 · 1 trial · 1 indication

Phase 1 1
NCT06480565A Phase 1/2 Trial of ADI-270 in ccRCCClear Cell Renal Cell Carcinoma
ACTIVE NOT_RECRUITING60 Analytics
PHASE1ACTIVE NOT_RECRUITING
A Phase 1/2 Trial of ADI-270 in ccRCC
Clear Cell Renal Cell CarcinomaUnlock trial analytics

Study Endpoints

Primary Endpoints

The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort
Day 28

This primary endpoint will be used to determine the Maximum Tolerated Dose (MTD) or Maximum Assessed dose (MAD)

Proportion of treatment emergent and treatment related adverse events
2 years

This primary endpoint will be used to determine the MTD/MAD of ADI-270

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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Dose EscalationEXPERIMENTALADI-270 is administered at ascending dose levels as a single dose to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD) of ADI-270
Dose ExpansionEXPERIMENTALDose Expansion with ADI-270 at the MTD/MAD to confirm recommended phase 2 dose (Part 2).

Interventions

NameTypeDescription
ADI-270DRUGAnti-CD70 CAR-T
FludarabineDRUGChemotherapy for Lymphodepeletion
CyclophosphamideDRUGChemotherapy for Lymphodepletion
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Eligibility Criteria

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

Inclusion Criteria: 1. Histologically or cytologically confirmed clear cell RCC 2. Documented evidence of advanced or metastatic diseases. 3. Patients must have been treated with an immune checkpoint inhibitor and a VEGF inhibitor (the VEGF inhibitor must have been administered in the advanced and/...

Countries:United States
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Recent Changes (Last 90 Days)

LOWMay 26, 2026NCT06480565primaryCompletionDate: changed
LOWMay 24, 2026NCT06480565studyFirstPostDate: changed

Frequently asked questions about ADI-270

What is ADI-270 used for?

ADI-270 is an investigational small molecule being developed for the treatment of Clear Cell Renal Cell Carcinoma (ccRCC). It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug has received Fast Track designation from the FDA.

Who makes ADI-270?

ADI-270 is being developed by Adicet Bio, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ACET. The company is conducting clinical trials for this investigational drug in the United States.

What phase is ADI-270 in?

ADI-270 is in Phase 1 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA. The drug has received Fast Track designation, which is intended to expedite the development and review of therapies for serious conditions.

What clinical trials is ADI-270 in?

ADI-270 is being studied in a Phase 1/2 clinical trial with the identifier NCT06480565. This trial is active but not recruiting participants, with an estimated enrollment of 60 patients. The study is being conducted in the United States and includes adults aged 18 years and older.

Is ADI-270 FDA approved?

No, ADI-270 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The FDA has granted Fast Track designation to ADI-270 for the treatment of Clear Cell Renal Cell Carcinoma, which may expedite its development and review process.