Clinical Trial 24094

• Overview

  Study Title:

  An Interventional Open-Label Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, and Preliminary Efficacy of PF-08634404 in Combination with Different Anticancer Agents in Participants with Advanced Solid Tumors

  Summary:

  This study is being done to learn more about a new medicine called PF-08634404 and how it works when used with other cancer medicines in people who have advanced solid tumors. An advanced solid tumor is a type of cancer that has spread beyond its original location and cannot be removed by surgery or cured with standard treatments.

  Objective:

  Phase 1 - Primary Objective(s): *To evaluate safety and tolerability of PF-08634404 + SV or PF-08634404 + PF-08046054 Phase 1 - Secondary Objective(s): *To evaluate the antitumor efficacy of PF-08634404 + SV or PF-08634404 + PF-08046054 *To evaluate additional measurement of safety of PF-08634404 + SV or PF-08634404 + PF-08046054 *To evaluate the PK of PF-08634404 + SV or PF-08634404 + PF-08046054 when administered in combination *To evaluate the immunogenicity of PF-08634404 + SV or PF-08634404 + PF-08046054 when administered in combination Phase 2 - Primary Objective(s): *To evaluate antitumor efficacy in PF-08634404 + SV or PF-08634404 + PF-08046054 *To evaluate safety and tolerability of PF-08634404 + SV or PF-08634404 + PF-08046054 *To identify a recommended dose of PF-08634404 + SV or PF-08634404 + PF-08046054 Phase 2 - Secondary Objective(s): *To evaluate additional measures of efficacy for PF-08634404 + SV or PF-08634404 + PF-08046054 *To evaluate additional measurement of safety of PF-08634404 + SV or PF-08634404 + PF-08046054 *To evaluate the PK of PF-08634404 + SV or PF-08634404 + PF-08046054 when administered in combination *To evaluate the immunogenicity of PF-08634404 + SV or PF-08634404 + PF-08046054 when administered in combination

• Treatments

  Therapies:

  Bispecific antibody targeting human PD-1 and VEGF; Vedotin-based ADC targeting programmed death-ligand 1 (PD-L1)

  Medications:

  PF-08046054 (); PF-08634404 (); Sigvotatug Vedotin ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Pathologically confirmed locally advanced (Stage IIIB/IIIC) or metastatic (Stage IV) squamous or non-squamous NSCLC and are not a candidate for complete surgical resection and curative concurrent/sequential chemoradiotherapy
  • PD-L1 status available
  • Part B only: PD-L1 ≥ TPS 1%
  • Measurable disease based on RECIST v1.1 per investigator.
  • Eastern Cooperative Oncology Group performance status of 0 or 1.
  • Adequate organ function

• Exclusion Criteria

  Key Exclusion Criteria:
  • Participants with known AGAs including EGFR, ALK and ROS1, NTRK, BRAF, and MET for which there are available first-line therapies per local standard-of-care (SOC)
  • History of another malignancy within 2 years before the first dose of study intervention, or any evidence of residual disease from a previously diagnosed malignancy
  • Known active CNS lesions, including brainstem, meningeal, or spinal cord metastases or compression
  • Leptomeningeal disease
  • Active autoimmune diseases requiring systemic treatment within the past 2 years
  • Previous systemic anti-tumor therapy for locally advanced or metastatic NSCLC
  • Previous treatment with immunotherapy (exception is (neo)adjuvant or consolidation anti-PD-(L)1), ADCs containing MMAE payload, systemic anti-angiogenic therapy, or prior radiotherapy >30 Gy to the lung within 6 months of first dose of study intervention

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