Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Castration-resistant Prostate Cancer | Castration-Resistant Prostate Carcinoma | ALIAS | 0.90 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Uterine Leiomyoma | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LFA102 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Breast & Prostate Cancer Group
- description
- Dose Escalation
- interventionNames
- Drug: LFA102
- type
- EXPERIMENTAL
- label
- Breast Cancer Group
- description
- Dose Expansion
- interventionNames
- Drug: LFA102
- type
- EXPERIMENTAL
- label
- Prostate Cancer Group
- description
- Dose Expansion
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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/exclusion criteria may apply
References
Publications (1)
- DERIVEDAgarwal N, Machiels JP, Suarez C, Lewis N, Higgins M, Wisinski K, Awada A, Maur M, Stein M, Hwang A, Mosher R, Wasserman E, Wu G, Zhang H, Zieba R, Elmeliegy M. Phase I Study of the Prolactin Receptor Antagonist LFA102 in Metastatic Breast and Castration-Resistant Prostate Cancer. Oncologist. 2016 May;21(5):535-6. doi: 10.1634/theoncologist.2015-0502. Epub 2016 Apr 18. PMID 27091421