Trial record 1 of 1 for:
LAVA-051
Trial of LAVA-051 in Patients With Relapsed/Refractory CLL, MM, or AML
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| ClinicalTrials.gov Identifier: NCT04887259 |
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Recruitment Status :
Recruiting
First Posted : May 14, 2021
Last Update Posted : March 21, 2023
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Sponsor:
Lava Therapeutics
Information provided by (Responsible Party):
Lava Therapeutics
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Brief Summary:
A phase 1/2a, first-in-human trial to evaluate the safety and tolerability of LAVA-051 in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL), Multiple Myeloma (MM), or Acute Myeloid Leukemia (AML).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Lymphocytic Leukemia Multiple Myeloma Acute Myeloid Leukemia | Biological: LAVA-051 | Phase 1 Phase 2 |
An open-label, phase 1/2a dose escalation trial with disease-specific expansion cohorts to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary anti-tumor activity of LAVA-051 in patients with relapsed or refractory CLL, MM, or AML.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 102 participants |
| Allocation: | N/A |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 1/2a Open-label Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Antitumor Activity of LAVA-051 in Patients With Relapsed or Refractory CLL, MM, or AML |
| Actual Study Start Date : | July 12, 2021 |
| Estimated Primary Completion Date : | September 24, 2024 |
| Estimated Study Completion Date : | December 30, 2024 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Multiple myeloma
Familial acute myeloid leukemia with mutated CEBPA
Cytogenetically normal acute myeloid leukemia
Core binding factor acute myeloid leukemia
| Arm | Intervention/treatment |
|---|---|
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Experimental: LAVA-051
In part 1 (dose escalation) LAVA-051 will be administered via intravenous infusion with dose escalation In part 2 (dose expansion) patients will receive LAVA-051 at the dose established in part 1 of the study |
Biological: LAVA-051
In part 1 and part 2, LAVA-051 will be administered via intravenous infusion |
Primary Outcome Measures :
- Part 1 & Part 2 - Frequency and severity of AEs: [ Time Frame: Approximately 6 months ]Frequency, severity, and grading of Adverse Events using the Common Terminology Criteria and grading for Adverse Events (CTCAE) v5.0. CRS will be evaluated using the ASTCT.
- Part 1 - Frequency and type of DLT [ Time Frame: First 28 days of treatment ]A DLT is defined as an adverse event that is unrelated to disease progression, intercurrent illness, or concomitant medications and is occurring during the first 28 days of treatment. These events will be classified according to the CTCAE v5.0; CRS will be evaluated according to the ASTCT consensus criteria
Secondary Outcome Measures :
- Part 1 & Part 2: Number of participants with an antitumor response [ Time Frame: Approximately 6 months ]Antitumor response for CLL per iwCLL guidelines, MM per IMWG-based response criteria, and AML per ELN criteria
- Part 1 & Part 2: Pharmacokinetics of LAVA-051, area under the plasma concentration versus time curve (AUC) [ Time Frame: Approximately 6 months ]Area under the plasma concentration versus time curve (AUC) of LAVA-051 will be assessed in all patients treated with LAVA-051
- Part 1 & Part 2: Incidence and prevalence anti-LAVA-051 antibodies [ Time Frame: Approximately 6 months ]Development of antibodies (anti-drug antibodies) to LAVA-051 will be evaluated
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
INCLUSION CRITERIA
- Patient must be 18 years of age inclusive or above at the time of signing the informed consent.
- Patients with documented diagnosis of relapsed or refractory CLL, MM, or AML who have failed to respond to or who have relapsed after prior therapy and are not amenable to standard treatments or for whom no standard treatments are available.
- Predicated life expectancy of ≥ 3 months.
- ECOG performance status of 0 or 1.
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Males or non-pregnant, non-breastfeeding females who are either:
- Surgically sterile.
- Female of childbearing potential with a negative pregnancy test and compliant with an effective contraceptive regimen.
- Female, postmenopausal.
- Male compliant with an effective contraceptive regimen.
- Male refraining from donating sperm.
- Capable of giving signed and dated informed consent prior to initiation of any trial-related procedures.
EXCLUSION CRITERIA
- Prior allogeneic bone marrow transplant if the patient still has active acute or chronic graft versus host disease requiring >10 mg prednisone or equivalent corticosteroids.
- Concomitant malignancies except carcinoma in situ, basal or squamous cell skin carcinoma. Patients who had no evidence of disease from another primary cancer for 2 or more years are allowed to participate in the trial. Localized non-metastatic prostate cancer, not requiring systemic treatment, and for which no local treatment is planned, is allowed.
- Uncontrolled or severe intercurrent medical condition.
- Previous treatment with an aminobisphonsphonate IV (e.g. ibandronate, pamidronate, zoledronate) within 4 weeks prior to initial IMP administration.
- Known ongoing drug or alcohol abuse in the opinion of the investigator.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04887259
Contacts
| Contact: Clinical Trials Administrator | 1-800-311-6892 | clinicaltrials@lavatherapeutics.com |
Locations
Show 21 study locations
Sponsors and Collaborators
Lava Therapeutics
Investigators
| Study Director: | Clinical Trials Management | Lava Therapeutics |
| Responsible Party: | Lava Therapeutics |
| ClinicalTrials.gov Identifier: | NCT04887259 |
| Other Study ID Numbers: |
LV2020-001 |
| First Posted: | May 14, 2021 Key Record Dates |
| Last Update Posted: | March 21, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Lava Therapeutics:
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CLL Phase 1 dose escalation Phase 1 safety Phase 2 safety Open label |
MM AML relapsed refractory |
Additional relevant MeSH terms:
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Leukemia Multiple Myeloma Leukemia, Lymphocytic, Chronic, B-Cell Neoplasms by Histologic Type Neoplasms Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias |
Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Leukemia, Lymphoid Lymphatic Diseases Leukemia, B-Cell |