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Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer

Primary Purpose

Metastatic Castration Resistant Prostate Cancer

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

LAVA-1207

About this trial

This is an interventional treatment trial for Metastatic Castration Resistant Prostate Cancer focused on measuring prostate cancer, PSMA, mCRPC, Phase 1 dose escalation, Phase 1 safety, Phase 2 safety, open-label

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

INCLUSION CRITERIA:

Patient must be 18 years of age inclusive or above, at the time of signing the informed consent.
Male patient with mCRPC with measurable or evaluable disease
Patient should have failed at least 1 line of taxane-based chemotherapy
Patient should have received a 2nd generation or later androgen receptor targeted therapy/ androgen biosynthesis inhibitor
Patients with evidence of progressive disease
Predicted life-expectancy of ≥ 6 months.
ECOG performance status of 0 or 1.
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
Capable of giving signed and dated informed consent prior to initiation of any trial-related procedures

EXCLUSION CRITERIA

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

Sites / Locations

Moffitt Cancer CenterRecruiting
Washington University School of Medicine in St. LouisRecruiting
NYU Langone HealthRecruiting
Huntsman Cancer Institute, University of UtahRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

LAVA-1207

Arm Description

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

Outcomes

Primary Outcome Measures

Part 1 & Part 2: Frequency and severity of AEs

Frequency and severity of Adverse Events using the Common Terminology Criteria and grading for Adverse Events

Part 1: Frequency and type of DLT

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

Part 1 & Part 2: Number of participants with an antitumor response

According to immune Response Evaluation Criteria in Solid Tumors (iRECIST)

Part 1 & Part 2: Pharmacokinetic of LAVA-1207, area under the concentration versus time curve (AUC)

Area under the plasma concentration versus time curve (AUC) of LAVA-1207 will be assessed in all patients

Part 1 & Part 2: Incidence and prevalence of anti-LAVA-1207 antibodies

Development of antibodies (anti-drug antibodies) to LAVA-1207 will be evaluated

Part 1 & Part 2: Biomarkers, binding of LAVA-1207 to Vγ9Vδ2-T cells

Binding of LAVA-1207 to Vγ9Vδ2-T cells will be measured in whole blood

Full Information

NCT ID

NCT05369000

First Posted

April 29, 2022

Last Updated

November 18, 2022

Sponsor

Lava Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT05369000

Brief Title

Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 27, 2022 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lava Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Castration Resistant Prostate Cancer

Keywords

prostate cancer, PSMA, mCRPC, Phase 1 dose escalation, Phase 1 safety, Phase 2 safety, open-label

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

LAVA-1207

Arm Type

Experimental

Arm Description

Intervention Type

Biological

Intervention Name(s)

LAVA-1207

Intervention Description

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

Primary Outcome Measure Information:

Title

Part 1 & Part 2: Frequency and severity of AEs

Description

Frequency and severity of Adverse Events using the Common Terminology Criteria and grading for Adverse Events

Time Frame

Approximately 6 months

Title

Part 1: Frequency and type of DLT

Description

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.

Time Frame

First 28 days of treatment

Secondary Outcome Measure Information:

Title

Part 1 & Part 2: Number of participants with an antitumor response

Description

According to immune Response Evaluation Criteria in Solid Tumors (iRECIST)

Time Frame

Approximately 6 months

Title

Part 1 & Part 2: Pharmacokinetic of LAVA-1207, area under the concentration versus time curve (AUC)

Description

Area under the plasma concentration versus time curve (AUC) of LAVA-1207 will be assessed in all patients

Time Frame

Approximately 6 months

Title

Part 1 & Part 2: Incidence and prevalence of anti-LAVA-1207 antibodies

Description

Development of antibodies (anti-drug antibodies) to LAVA-1207 will be evaluated

Time Frame

Approximately 6 months

Title

Part 1 & Part 2: Biomarkers, binding of LAVA-1207 to Vγ9Vδ2-T cells

Description

Binding of LAVA-1207 to Vγ9Vδ2-T cells will be measured in whole blood

Time Frame

Approximately 6 months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

INCLUSION CRITERIA: Patient must be 18 years of age inclusive or above, at the time of signing the informed consent. Male patient with mCRPC with measurable or evaluable disease Patient should have failed at least 1 line of taxane-based chemotherapy Patient should have received a 2nd generation or later androgen receptor targeted therapy/ androgen biosynthesis inhibitor Patients with evidence of progressive disease Predicted life-expectancy of ≥ 6 months. ECOG performance status of 0 or 1. Males who are: Surgically sterile 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 Capable of giving signed and dated informed consent prior to initiation of any trial-related procedures EXCLUSION CRITERIA Uncontrolled or severe intercurrent medical condition. Patient has any active-, uncontrolled-, or suspected infection. Known clinically relevant immunodeficiency disorders. Unstable cardiovascular function Previous treatment with an aminobisphosphonate IV (e.g. ibandronate, pamidronate, zoledronate etc) within 4 weeks prior to initial IMP. Known ongoing drug and alcohol abuse in the opinion of the investigator.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Clinical Trials Administrator

Phone

800-311-6892

clinicaltrials@lavatherapeutics.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials Management

Organizational Affiliation

Lava Therapeutics

Official's Role

Study Director

Facility Information:

Facility Name

Moffitt Cancer Center

City

Tampa

State/Province

Florida

ZIP/Postal Code

33612

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jingsong Zhang, MD, PhD

First Name & Middle Initial & Last Name & Degree

Tanner Pearson

Phone

813-745-6552

tanner.pearson@moffit.org

Facility Name

Washington University School of Medicine in St. Louis

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63110

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Joel Picus, MD

Facility Name

NYU Langone Health

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David R. Wise, MD, PhD

david.wise@nyulangone.org

Facility Name

Huntsman Cancer Institute, University of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84112

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Umang Swami, MD, MS

First Name & Middle Initial & Last Name & Degree

Susan Sharry

Phone

801-585-3453

susan.sharry@hci.utah.edu

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer

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