A Study of a New Investigational Medicinal Product to Treat Patients with Advanced or Metastatic Solid Tumors

Phase I/II Open Label Dose Escalation and Dose Expansion Study of Intravenous Infusion of W0101, an Antibody-drug Conjugate, in Patients with Advanced or Metastatic Solid Tumors. International, Multicenter, Open Label Study

Status

Terminated

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03316638

Acronym

Ulysse

Enrollment

316

Registered

2017-10-20

Start date

2017-11-24

Completion date

2022-07-05

Last updated

2024-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced or Metastatic Solid Tumors

Brief summary

W0101 combines a cytotoxic compound to a monoclonal antibody targeting a receptor commonly overexpressed in many cancers. The development of antibody-drug conjugates takes advantage of the specificity of the mAb while augmenting its ability to produce a cytotoxic effect. The expected benefits of antibody-drug conjugation are enhancement of cytotoxicity in target cells and limiting toxicities of cytotoxic drugs in normal tissues.

Detailed description

This is a First In Human study, multicenter, open label study divided into 2 parts: an initial dose escalation phase (I) followed by expansion cohort(s) phase (II).

Interventions

DRUGW0101 - Cohort A1

Administered once every 2 weeks

DRUGW0101 - Cohort A2

Administered every 3 weeks

DRUGW0101 - Expansion Phase

Administered according to the recommended dose for expansion

Study design

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

2 Cohorts

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Dose escalation phase (cohort A1 and A2) 1. Male or female subjects age ≥ 18 years 2. Subjects with histologically or cytologically confirmed advanced or metastatic solid tumors (excluding lymphoma) , unresponsive to standard treatment or for whom no standard treatment is available or appropriate 3. ECOG performance status 0 or 1 4. Adequate bone marrow, renal, hepatic at screening and at Baseline 5. Subject must have measurable diseases as per RECIST v1.1 criteria

Exclusion criteria

1. Symptomatic brain metastases, CNS tumors 2. Symptomatic motor or sensory peripheral neuropathy (≥ grade 2) 3. Subjects having ophthalmologic abnormalities 4. Active serious systemic disease (infection,organic or dysmetabolic desease) 5. Left ventricular ejection fraction (LVEF) \< 45% as determined by MUGA scan or echography at screening 6. QTc \> 470 msec on screening ECG or congenital long QT syndrome 7. Biologic therapy (including ADCs ≤ 4 weeks before first study treatment administration)

Design outcomes

Primary

Measure	Time frame	Description
Incidence of Specific Adverse Events	28 days	Identification of Dose-limiting toxicities

Countries

France, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 23, 2026