Phase 1
N=62
A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A In Patients With Non-Hodgkin's Lymphoma
Lymphoma, Non-Hodgkin; Leukemia, Chronic Lymphocytic
Bottom Line
View on ClinicalTrials.gov: NCT02594384 ↗Enrolled (actual)
62
Serious AEs
41.9%
Results posted
Aug 2024
Primary outcome: Primary: Determination of the Maximum Tolerated Dose (MTD) of Continuous Oral LAM-002A — 125 mg BID
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- LAM-002A (Drug); Rituximab (Drug); Atezolizumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- OrphAI Therapeutics
- Primary completion
- Mar 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Determination of the Maximum Tolerated Dose (MTD) of Continuous Oral LAM-002A |
125 | — |
| SECONDARY Peak Plasma Concentration (Cmax) of LAM-002A |
117; 158; 263; 207; 243; 280 | — |
| SECONDARY Area Under the Plasma Concentration Versus Time Curve (AUC) of LAM-002A |
238; 583; 515; 562; 700; 777 | — |
| SECONDARY Objective Response Rate |
0; 0; 0; 0; 0; 0 | — |
Summary
This is a Phase 1 dose-exploration study of LAM-002A administered by mouth in patients with relapsed or refractory B-cell NHL. Safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD),and preliminary anti-tumor activity will be evaluated.
Eligibility Criteria
Inclusion Criteria
- Able to understand and comply with the protocol requirements and has signed the informed consent document.
- Confirmed diagnosis of B-cell Non-Hodgkin's lymphoma limited to follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), primary mediastinal B-cell lymphoma (PMBL), or chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) that has progressed and for which standard curative measures do not exist or are no longer effective. Prior therapy must have included a rituximab-based regimen.
- Patients with DLBCL: Cancer progression after transplant, or be unwilling, unable or not an appropriate candidate for an autologous stem cell or bone marrow transplant
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of 1 or more lesions that measure at least 2.0 cm in the longest dimension (as assessed radiographically)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 2 or less.
- Adequate organ and marrow function.
- Able to swallow oral capsules without difficulty.
- Acceptable birth control.
- Women of childbearing potential : negative pregnancy test
- Adequate archival or fresh tumor tissue (from biopsy, bone marrow, or peripheral blood) for analysis of potential predictive biomarkers.
Exclusion Criteria
- Patients with central nervous system (CNS) lymphoma are not eligible for the trial unless the disease had been treated and the subject remains without symptoms with no active CNS lymphoma.
- Not recovered from toxicity due to all prior therapies.
- Other uncontrolled significant illness.
- History of malabsorption or other gastrointestinal (GI) disease that may significantly alter the absorption of LAM-002A
- Major surgery within 28 days prior to first dose of study drug.
- Past history of tuberculosis (TB) or active infection with TB, human immunodeficiency virus (HIV), hepatitis B or hepatitis C.
- Lactation or breast feeding.
- Unable or unwilling to abide by the study protocol or cooperate fully with the Investigator or designee.
This is a shortened list and additional criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02594384). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.