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, alone or with low dose interleukin-2 or Pembrolizumab, in patients with therapy refractory metastatic castration resistant prostate cancer

Recruiting

Conditions: mCRPC
Prostate cancer
10038597

Registration Number: NL-OMON56169

Lead Sponsor: AVA Therapeutics NV

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 42

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 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.
Patients is unlikely to tolerate or derive clinically meaningful benefit from
other
available therapy.
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.

Exclusion Criteria

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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoints<br /><br><br /><br>Part 1 Dose Escalation for LAVA-1207 alone, LAVA-1207 plus LDSC IL-2, and<br /><br>LAVA-1207 plus pembrolizumab<br /><br>Frequency and severity of AEs using the Common Terminology Criteria for Adverse<br /><br>Events (CTCAE) version 5.0 and ASTCT grading for CRS.<br /><br>Frequency and type of DLT.<br /><br><br /><br>Part 2 Expansion Cohort for LAVA-1207 alone and/or LAVA-1207 plus LDSC IL-2,<br /><br>and/or LAVA-1207 plus pembrolizumab<br /><br>Frequency and severity of AEs using the CTCAE version 5.0 and ASTCT grading of<br /><br>CRS at the RP2D.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints<br /><br><br /><br><br /><br>Part 1 Dose Escalation and Part 2 Expansion Cohort (for LAVA-1207 alone and/or<br /><br>LAVA-1207 plus LDSC IL-2 and/or LAVA-1207 plus pembrolizumab)<br /><br>Number of participants with an antitumor response according to immune response<br /><br>evaluation criteria in solid tumors (RECIST and iRECIST) in patients with<br /><br>measurable disease.<br /><br>Duration of response.<br /><br>Disease control rate (DCR) for patients with measurable disease at 8, 16 and 24<br /><br>weeks.<br /><br>Number of participants who experience any PSA decrease, and number of<br /><br>participants who experience a PSA decrease of >= 50% from baseline.<br /><br>Progression free survival (using Prostate Cancer Working Group 3 [PCWG3] for<br /><br>bone lesions and/or iRECIST criteria for soft-tissue lesions).<br /><br>Pharmacokinetic parameters.<br /><br>Pharmacodynamic markers.<br /><br>Incidence and prevalence of anti-LAVA-1207 antibodies.</p><br>