Phase I Study of LFA102 in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer

A Phase I, Multicenter, Open-label Study of LFA102 Administered Intravenously in Patients With Prolactin Receptor-positive Castration-resistant Prostate Cancer or Prolactin Receptor-positive Metastatic Breast Cancer

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01338831

Enrollment

Registered

2011-04-20

Start date

2011-09-30

Completion date

2014-03-31

Last updated

2020-12-17

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

Conditions

Castration-resistant Prostate Cancer, Metastatic Breast Cancer, Uterine Leiomyoma

Keywords

prostate cancer,, breast cancer,, prolactin,, prolactin receptor, uterine leiomyoma

Brief summary

The purpose of this first multi-dose study in cancer patients is to determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D), characterize the safety, tolerability and pharmacokinetics profile. Once the MTD has been established and/or a RP2D chosen, the study will enroll patients into the expansion portion of the study.

Interventions

DRUGLFA102

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Histologically confirmed diagnosis of prostate cancer, breast cancer, or uterine leiomyoma 2. Detectable metastases by bone scan, CT-scan, or MRI. 3. Presence of prolactin receptor in primary or metastatic tumor (Dose Escalation only) 4. Suitable venous access for blood sampling

Exclusion criteria

1. Prior treatment with any anti-prolactin receptor antibody 2. Major surgery within 28 days before study treatment 3. Patients who have received radiotherapy ≤ 2 weeks prior to starting study drug 4. Prior anaphylactic or other severe infusion reaction to antibody formulations Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Incidence rate of Dose Limiting Toxicity	4 weeks

Secondary

Measure	Time frame
LFA102 serum concentration	6 months
Disease response	every 2 to 3 months
Concentrations of antibodies to LFA102	every month

Countries

Belgium, Italy, Spain, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026