A Study in Advanced/Metastatic Solid Tumors With the Study Medicine (PF-07329640) When Given Alone or In Combination

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
Pfizer
Study ID
NCT06448364
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PF-07329640 — BIOLOGICAL
    an anti-lymphotoxin beta receptor agonist
  • sasanlimab — BIOLOGICAL
    A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2
  • bevacizumab — BIOLOGICAL
    a monoclonal antibody that blocks VEGF

Study Details

The purpose of this study is to learn about the safety (the impact of the study drug on the participant's body), effects of the study drug alone or in combination with bevacizumab or sasanlimab, and to find the best dose. This study is seeking participants who have solid tumors that: * have advanced (cancer that doesn't disappear or stay away with treatment) or * has spread to other parts of the body (metastatic). This includes (but limited to) the following cancer types: * Non-Small Cell Lung Cancer (NSCLC): It's a type of lung cancer where the cells grow slowly but often spread to other parts of the body. * Colorectal Cancer (CRC): This is a disease where cells in the colon or rectum grow out of control. * Urothelial Cancer (UC): This is a cancer that starts in the urinary systems. * Melanoma: Skin cancer that develops when melanocytes (the cells that give the skin its tan or brown color) start to grow out of control. All participants in this study will receive the study medication (PF-07329640) as an IV infusion (given directly into a vein) at the study clinic every week for repeating 28-day cycles. Depending on which part of the study participants are enrolled in they will receive the study medication (PF-07329640 alone or in combination with other anti-cancer medications (bevacizumab or sasanlimab). Bevacizumab is given in the clinic as IV infusion every two weeks and sasanlimab is given as a shot under the skin every 4 weeks. Participants can continue to take the study medication (PF-07329640) and bevacizumab until their cancer is no longer responding. Participants who are taking sasanlimab may receive it for up to 2 years. The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and effective. Participants will be involved in this study for up to 4 years. During this time, they will have a study visit every week. After they have stopped taking the study medication (at about at 2 years) they will be followed for another two years to see how they are doing.

Key Dates

First listed
Jun 7, 2024
Start date
May 9, 2024
Status verified
Nov 2024
Primary completion
Aug 15, 2024
Completion
Aug 15, 2024

Study Design

Enrollment
4 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A: PF-07329640 (αLTβR) Monotherapy
    PF-07329640 (αLTβR) monotherapy at prescribed dose and frequency in 28-day cycles
  • Experimental: Part 1B: PF-07329640 (αLTβR) + bevacizumab
    PF-07329640 (αLTβR) + bevacizumab dose escalation in NSCLC and MSS CRC at prescribed dose and frequency in 28-day cycles
  • Experimental: Part 1C: PF-07329640 (αLTβR) + sasanlimab
    PF-07329640 (αLTβR) + sasanlimab dose escalation in NSCLC, melanoma, UC, and MSS CRC at prescribed dose and frequency in 28-day cycles
  • Experimental: Part 2A: PF-07329640 (αLTβR) + bevacizumab
    PF-07329640 (αLTβR) + bevacizumab dose expansion in NSCLC 2L+ and MSS CRC 2L+ at prescribed dose and frequency in 28-day cycles
  • Experimental: Part 2B: PF-07329640 (αLTβR) + sasanlimab
    PF-07329640 (αLTβR) + sasanlimab dose expansion in NSCLC, melanoma, UC, and MSS CRC at prescribed dose and frequency in 28-day cycles
  • Experimental: Part 2C: PF-07329640 (αLTβR) + SOC
    PF-07329640 (αLTβR) + SOC (anti-PD-1+ platinum-based chemo) dose expansion for αPDx-naïve NSCLC 1L at prescribed dose and frequency in 28-day cycles
  • Experimental: Part 2D: PF-07329640 (αLTβR)
    PF-07329640 (αLTβR) dose expansion in advanced solid tumors at prescribed dose and frequency in 28-day cycles

Primary Outcome Measure

PART 1: Number of participants with Dose-limiting toxicities (DLT) [ Time Frame: First cycle, Day 1 up to Day 28 ]

Locations (4)

FacilityCityStateZIPSite coordinators
Highlands OncologyFayettevilleArkansas72703-
Highlands OncologyRogersArkansas72758-
Highlands Oncology GroupSpringdaleArkansas72762-
NEXT OncologySan AntonioTexas78229-

Find similar trials in Fayetteville, AR

By condition
Colorectal cancerMelanomaLung cancerBladder cancer
By specialty
OncologyGI oncologySkin cancerDermatologyLung oncologyLung diseaseUrology
By research site
Highlands Oncology· Fayetteville, ARHighlands Oncology· Rogers, ARHighlands Oncology Group· Springdale, ARNEXT Oncology· San Antonio, TX

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