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

Metastatic Castration Resistant Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05369000
• Other study ID #: LAVA1207-002
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 27, 2022
• Est. completion date: March 2024

Study information

• Verified date: November 2022
• Source: Lava Therapeutics
• Contact: Clinical Trials Administrator
• Phone: 800-311-6892
• Email: clinicaltrials[@]lavatherapeutics.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66
• Est. completion date: March 2024
• Est. primary completion date: September 2023
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metastatic Castration Resistant Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York
United States	Washington University School of Medicine in St. Louis	Saint Louis	Missouri
United States	Huntsman Cancer Institute, University of Utah	Salt Lake City	Utah
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Lava Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Approximately 6 months
Primary	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.	First 28 days of treatment
Secondary	Part 1 & Part 2: Number of participants with an antitumor response	According to immune Response Evaluation Criteria in Solid Tumors (iRECIST)	Approximately 6 months
Secondary	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	Approximately 6 months
Secondary	Part 1 & Part 2: Incidence and prevalence of anti-LAVA-1207 antibodies	Development of antibodies (anti-drug antibodies) to LAVA-1207 will be evaluated	Approximately 6 months
Secondary	Part 1 & Part 2: Biomarkers, binding of LAVA-1207 to V?9Vd2-T cells	Binding of LAVA-1207 to V?9Vd2-T cells will be measured in whole blood	Approximately 6 months