ADCE-T02, a Tissue Factor Targeted Antibody-Drug Conjugate, in Patients With Selected Advanced Solid Tumours

Part of paid clinical trials in Rogers, Arkansas.

Sponsor
Adcendo ApS
Study ID
NCT06597721
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ADCE-T02 — DRUG
    Administered intravenously

Study Details

Adcendo ApS is conducting a phase 1 study of an investigational drug called ADCE-T02 (previously known as AMT-754), a tissue factor targeted antibody-drug conjugate which may be used in the future as a possible treatment for advanced solid tumors. The main purpose of the study is to determine the Maximum Tolerated Dose (MTD), the recommended dose and the safety and tolerability of ADCE-T02 when given as a single therapy over a range of different dose levels. The expansion phase is now open for enrollment in indications including HNSCC and PDAC.

Key Dates

First listed
Sep 19, 2024
Start date
Nov 25, 2024
Status verified
Jul 2026
Primary completion
Mar 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
210 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ADCE-T02 Dose Escalation followed by an Expansion Phase

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of ADCE-T02 [ Time Frame: Up to 24 months ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Highlands Oncology GroupRogersArkansas72758-
Yale University Cancer CenterNew HavenConnecticut06520-
Massachusetts General HospitalBostonMassachusetts02114-
Washington UniversitySt LouisMissouri63110-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
MD Anderson Cancer CenterHoustonTexas77030-
START San AntonioSan AntonioTexas78229-

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Highlands Oncology Group· Rogers, ARYale University Cancer Center· New Haven, CTMassachusetts General Hospital· Boston, MAWashington University· St Louis, MOMemorial Sloan Kettering Cancer Center· New York, NYMD Anderson Cancer Center· Houston, TX

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