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
Overview
- Phase
- Phase 1
- Intervention
- LAVA-1207
- Conditions
- Metastatic Castration Resistant Prostate Cancer
- Sponsor
- Lava Therapeutics
- Enrollment
- 96
- Locations
- 12
- Primary Endpoint
- Part 1 & Part 2: Frequency and severity of AEs
- Status
- Terminated
- Last Updated
- 9 months ago
Overview
Brief 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
LAVA-1207
LAVA-1207
Intervention: LAVA-1207
LAVA-1207 with Low-Dose Subcutaneous IL-2 (LDSC IL-2)
LAVA-1207 with Low-Dose Subcutaneous IL-2 (LDSC IL-2)
Intervention: LAVA-1207
LAVA-1207 plus Pembrolizumab
LAVA-1207 plus Pembrolizumab
Intervention: LAVA-1207
LAVA-1207 plus Pembrolizumab
LAVA-1207 plus Pembrolizumab
Intervention: LAVA-1207 plus Pembrolizumab
Outcomes
Primary Outcomes
Part 1 & Part 2: Frequency and severity of AEs
Time Frame: Approximately 24 months
Frequency and severity of Adverse Events using the Common Terminology Criteria and grading for Adverse Events and grading for CRS
Part 1: Frequency and type of DLT
Time Frame: First 28 days of treatment
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.illness, or concomitant medications and is occurring during the first 28 days of treatment.
Secondary Outcomes
- Part 1 & Part 2: Number of participants with an antitumor response(Approximately 24 months)
- Part 1 & Part 2: Incidence and prevalence of anti-LAVA-1207 antibodies(Approximately 6 months)
- Part 1 & Part 2: Pharmacokinetic of LAVA-1207, area under the concentration versus time curve (AUC)(Approximately 6 months)
- Part 1 & Part 2: Biomarkers, binding of LAVA-1207 to Vγ9Vδ2-T cells(Approximately 24 months)