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Trial record 1 of 1 for:    LAVA1207
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Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer

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ClinicalTrials.gov Identifier: NCT05369000
Recruitment Status : Recruiting
First Posted : May 11, 2022
Last Update Posted : November 21, 2022
Sponsor:
Information provided by (Responsible Party):
Lava Therapeutics

Study Description
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Brief Summary:
This is a phase 1/2a, first-in-human study to evaluate the safety and tolerability of LAVA-1207 in patients with therapy refractory metastatic castration resistant prostate cancer

Condition or disease Intervention/treatment Phase
Metastatic Castration Resistant Prostate Cancer Biological: LAVA-1207 Phase 1 Phase 2

Detailed Description:
This trial is an open-label Phase 1 and 2a dose escalation trial with an expansion cohort to investigate the safety and tolerability of LAVA-1207 in patients with therapy refractory mCRPC.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1/2a Open-label Trial to Evaluate the Safety, Tolerability, PK, PD, Immunogenicity, and Antitumor Activity of LAVA-1207, a PSMA-targeting Bispecific γδ-T Cell Engager, in Patients With Therapy Refractory mCRPC
Actual Study Start Date : June 27, 2022
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: LAVA-1207

In part 1 (dose escalation) LAVA-1207 will be administered via intravenous infusion with dose escalation

In part 2 (dose expansion) patients will receive LAVA-1207 at the dose established in part 1 of the study

 Biological: LAVA-1207
In part 1 & part 2 LAVA-1207 will be administered via intravenous infusion.


Outcome Measures
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Primary Outcome Measures :
  1. Part 1 & Part 2: Frequency and severity of AEs [ Time Frame: Approximately 6 months ]
    Frequency and severity of Adverse Events using the Common Terminology Criteria and grading for Adverse Events

  2. 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.


Secondary Outcome Measures :
  1. Part 1 & Part 2: Number of participants with an antitumor response [ Time Frame: Approximately 6 months ]
    According to immune Response Evaluation Criteria in Solid Tumors (iRECIST)

  2. Part 1 & Part 2: Pharmacokinetic of LAVA-1207, area under the concentration versus time curve (AUC) [ Time Frame: Approximately 6 months ]
    Area under the plasma concentration versus time curve (AUC) of LAVA-1207 will be assessed in all patients

  3. Part 1 & Part 2: Incidence and prevalence of anti-LAVA-1207 antibodies [ Time Frame: Approximately 6 months ]
    Development of antibodies (anti-drug antibodies) to LAVA-1207 will be evaluated

  4. Part 1 & Part 2: Biomarkers, binding of LAVA-1207 to Vγ9Vδ2-T cells [ Time Frame: Approximately 6 months ]
    Binding of LAVA-1207 to Vγ9Vδ2-T cells will be measured in whole blood


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  1. Patient must be 18 years of age inclusive or above, at the time of signing the informed consent.
  2. Male patient with mCRPC with measurable or evaluable disease
  3. Patient should have failed at least 1 line of taxane-based chemotherapy
  4. Patient should have received a 2nd generation or later androgen receptor targeted therapy/ androgen biosynthesis inhibitor
  5. Patients with evidence of progressive disease
  6. Predicted life-expectancy of ≥ 6 months.
  7. ECOG performance status of 0 or 1.

  8. Males who are:

    1. Surgically sterile
    2. Compliant with an effective contraceptive regimen (i.e. use of male condom with female partner and assuring use of an additional highly effective contraceptive method with a failure rate
  9. Capable of giving signed and dated informed consent prior to initiation of any trial-related procedures

EXCLUSION CRITERIA

  1. Uncontrolled or severe intercurrent medical condition.
  2. Patient has any active-, uncontrolled-, or suspected infection.
  3. Known clinically relevant immunodeficiency disorders.
  4. Unstable cardiovascular function
  5. Previous treatment with an aminobisphosphonate IV (e.g. ibandronate, pamidronate, zoledronate etc) within 4 weeks prior to initial IMP.
  6. Known ongoing drug and alcohol abuse in the opinion of the investigator.
Contacts and Locations
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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): NCT05369000


Contacts
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Contact: Clinical Trials Administrator 800-311-6892 clinicaltrials@lavatherapeutics.com

Locations
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United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Jingsong Zhang, MD, PhD         
Contact: Tanner Pearson    813-745-6552    tanner.pearson@moffit.org   
United States, Missouri
Washington University School of Medicine in St. Louis Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Joel Picus, MD         
United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: David R. Wise, MD, PhD       david.wise@nyulangone.org   
United States, Utah
Huntsman Cancer Institute, University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Umang Swami, MD, MS         
Contact: Susan Sharry    801-585-3453    susan.sharry@hci.utah.edu   
Sponsors and Collaborators
Lava Therapeutics
Investigators
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Study Director: Clinical Trials Management Lava Therapeutics
More Information
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Responsible Party: Lava Therapeutics
ClinicalTrials.gov Identifier: NCT05369000    
Other Study ID Numbers: LAVA1207-002
First Posted: May 11, 2022    Key Record Dates
Last Update Posted: November 21, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Lava Therapeutics:
prostate cancer
PSMA
mCRPC
Phase 1 dose escalation
 Phase 1 safety
Phase 2 safety
open-label
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Genital Diseases, Male
Genital Diseases
Urogenital Diseases
Prostatic Diseases
Male Urogenital Diseases