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Clinical Trial 21433

Cancer Type: Genitourinary
Study Type: Treatment
NCT#: NCT05369000

Phase: Phase I
Principal Investigator: Zhang, Jingsong

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or 1-800-679-0775 Learn More

Overview

Study Title

A Phase 1 and 2a open-label trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity of LAVA-1207, a PSMA-targeting bispecific γδ-T cell engager, in patients with therapy refractory metastatic castration resistant prostate cancer

Summary

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.

Objective

Primary Objectives: Part 1 Dose Escalation To investigate the safety and tolerability of LAVA-1207 in patients with therapy refractory mCRPC. To determine the recommended Phase 2 dose (RP2D) of LAVA-1207 in patients with therapy refractory mCRPC. Part 2 Expansion Cohort To investigate the safety and tolerability of LAVA-1207 at the RP2D in therapy refractory mCRPC patients with measurable disease. Secondary Objectives Part 1 Dose Escalation and Part 2 Expansion Cohort To explore the preliminary antitumor activity of LAVA-1207. To evaluate the pharmacokinetics of LAVA-1207. To evaluate the pharmacodynamics of LAVA-1207. To evaluate the immunogenicity of LAVA-1207.

Treatments

Therapies

Immunotherapy

Medications

LAVA-1207 ()

Inclusion 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.

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

Other criteria may apply

Exclusion Criteria

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 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

Known ongoing drug and alcohol abuse in the opinion of the investigator.

Additional exclusions may apply

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