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

Sponsor

Lava Therapeutics (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05369000

Collaborator

(none)

Enrollment

Locations

Arm

20.1

Anticipated Duration (Months)

16.5

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

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

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

Study Type:

Interventional

Anticipated 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 :

Jun 27, 2022

Anticipated Primary Completion Date :

Sep 1, 2023

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

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.

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

Primary Outcome Measures

Part 1 & Part 2: Frequency and severity of AEs [Approximately 6 months]
Frequency and severity of Adverse Events using the Common Terminology Criteria and grading for Adverse Events
Part 1: Frequency and type of DLT [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

Part 1 & Part 2: Number of participants with an antitumor response [Approximately 6 months]
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) [Approximately 6 months]
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 [Approximately 6 months]
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 [Approximately 6 months]
Binding of LAVA-1207 to Vγ9Vδ2-T cells will be measured in whole blood

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts 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:
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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Moffitt Cancer Center	Tampa	Florida	United States	33612
2	Washington University School of Medicine in St. Louis	Saint Louis	Missouri	United States	63110
3	NYU Langone Health	New York	New York	United States	10016
4	Huntsman Cancer Institute, University of Utah	Salt Lake City	Utah	United States	84112