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Trial of LAVA-1207 in Patients With Therapy Refractory Metastatic Castration Resistant Prostate Cancer (mCRPC) Resistant Prostate Cancer | Clinical Trials | Clareo Health

TERMINATEDPHASE1

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

A Phase 1 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, Alone or With Low Dose Interleukin-2 or Pembrolizumab, in Patients With Therapy Refractory mCRPC

NCT05369000•Lava Therapeutics

View on ClinicalTrials.gov

Summary

This is a phase 1, first-in-human study to evaluate Safety, Tolerability, PK, PD, Immunogenicity, and Antitumor Activity of LAVA-1207 alone or with low dose interleukin-2 or Pembrolizumab, in patients with therapy refractory metastatic castration resistant prostate cancer.

Detailed Description

This trial is an open-label Phase 1 dose escalation trial with an expansion cohort to investigate the safety and tolerability of LAVA-1207 alone or with low dose interleukin-2 or Pembrolizumab, in patients with therapy refractory mCRPC. The trial was intended to be a Phase 1/2 trial (but the trial never moved forward to Phase 2).

Eligibility

Age

18 - No limit years

Sex

MALE

Healthy Volunteers

Inclusion Criteria

•Patients are eligible to be included in the arm only if all of the following criteria apply:
•1. Patient must be 18 years of age inclusive or above, at the time of signing the informed consent.
•2. Male patient with mCRPC as defined by PCWG3 criteria (histologically confirmed adenocarcinoma; adenocarcinoma with ≤10% small-cell or neuroendocrine features is allowed). Brain metastases are allowed as long as the patient's symptoms are well controlled.
•3. Patient should have failed at least 1 line of taxane-based chemotherapy or is deemed medically unsuitable to be treated with a taxane regimen.
•4. Patient should have received a 2nd generation or later androgen receptor targeted therapy/ androgen biosynthesis inhibitor (e.g., abiraterone,enzalutamide, and/or apalutamide). Progression on novel antiandrogen therapy may have occurred in the non-mCRPC setting.
•5. Patient is unlikely to tolerate or derive clinically meaningful benefit from other available therapy.
•6. Patient for which any drug-related toxicity adverse effects of any prior cancer therapy have resolved to Grade 1 or less according to CTCAE version 5.0 or to baseline severity level (except for alopecia and peripheral neuropathy).
•7. Patients with evidence of progressive disease, defined as 1 or more of the following criteria:
•1. PSA level ≥1 ng/mL that has increased on at least 2 successive occasions at least 1 week apart.
•2. Computed tomography (CT) or magnetic resonance imaging (MRI) scan: nodal or visceral progression as defined by RECIST 1.1.
+34 more criteria

Exclusion Criteria

•Patients are excluded from the trial if any of the following criteria apply:
•1. Other malignancies within the last 2 years except adequately treated carcinoma in situ, basal or squamous cell skin carcinoma.
•2. Uncontrolled or severe intercurrent medical condition.
•3. Positive serological testing for human immunodeficiency virus (HIV) antibody.
•4. Positive serological hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) negative, and hepatitis C virus (HCV) antibody. Patients who are positive for anti-HBc or hepatitis C antibody may be included if they have a negative polymerase chain reaction (PCR) within 6 weeks prior to initial IMP administration. Those who are PCR positive will be excluded.
•5. Patient has any active, uncontrolled, or suspected infection.
•6. Known clinically relevant immunodeficiency disorders.
•7. A significant history of renal, neurologic, psychiatric, pulmonary, endocrinologic, metabolic, immunologic, cardiovascular, or hepatic disease that in the opinion of the investigator would adversely affect participation in this trial.
•8. Unstable cardiovascular function defined as: (a) symptomatic ischemia, or (b) uncontrolled clinically significant conduction abnormalities (i.e. ventricular tachycardia on antiarrhythmic agents are excluded; 1st degree atrioventricular block or asymptomatic left anterior fascicular block/right bundle branch block is not excluded), or (c) congestive heart failure New York Heart Association Class ≥ 3, or (d) myocardial infarction within 3 months.
•9. Previous treatment with antitumor therapies within 2 weeks prior to initial IMP for radiotherapy and androgen receptor targeted therapy/androgen biosynthesis inhibitor, and within 4 weeks for systemic chemotherapy or targeted immunotherapy.
+32 more criteria

Locations (12)

UCSF Medical Center at Parnassus

San Francisco, California, United States

M Health Fairview University of Minnesota Medical Center

Minneapolis, Minnesota, United States

Washington University School of Medicine in St. Louis

St Louis, Missouri, United States

NYU Langone Health

New York, New York, United States

Duke University Medical Center - Duke Cancer Center

Durham, North Carolina, United States

Huntsman Cancer Institute, University of Utah

Salt Lake City, Utah, United States

Radboud Universiteit - Radboud Universitair Medisch Centrum (Radboudumc)

Nijmegen, Gelderland, Netherlands

Erasmus MC (Erasmus Universitair Medisch Centrum Rotterdam)

Rotterdam, South Holland, Netherlands

Amsterdam UMC - VU Medisch Centrum (VUmc)

Amsterdam, Netherlands

ICO Hospitalet (Hospital Duran i Reynals)

Barcelona, Spain

Key Dates

Start Date

January 17, 2022

Primary Completion Date

June 18, 2025

Completion Date

June 18, 2025

Last Updated

August 1, 2025

Enrollment

ACTUAL participants

Conditions

Metastatic Castration Resistant Prostate Cancer

Interventions

LAVA-1207

BIOLOGICAL

LAVA-1207 plus Pembrolizumab

BIOLOGICAL

AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)

NCT07285694

Metastatic Castration Resistant Prostate Cancer (mCRPC)

View study

RECRUITINGPHASE1

A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer

NCT06830850

Metastatic Castration Resistant Prostate Cancer

View study

RECRUITING

Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 1, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)

A Trial of HRS-5041-103 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-5041 in Subjects With Metastatic Castration-resistant Prostate Cancer

Real-world Experience With Lutetium Vipivotide Tetraxetan in Metastatic Castration Resistant Prostate Cancer

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Antitumor Activity of INV-9956 in Adult Patients With Advanced Metastatic Castration Resistant Prostate Cancer

A Study to Assess the Benefit of Treatment Beyond Progression With Enzalutamide in Men Who Are Starting Treatment With Docetaxel After Worsening of Their Prostate Cancer When Taking Enzalutamide Alone

Phase 1 Clinical Study of GT-220F in Subjects With Metastatic Castration Resistant Prostate Cancer (mCRPC)