Trial Title:
A Study to Learn About How Different Amounts of the Study Medicine PF-07826390 Act in the Body of People With Cancer When Taken Alone or With Other Anti-cancer Medicines.
NCT ID:
NCT06546553
Condition:
Neoplasms
Non-small-cell Lung Cancer
Squamous Cell Carcinoma of the Head and Neck
Renal Cell Carcinoma
Colorectal Carcinoma
Ovarian Carcinoma
Conditions: Official terms:
Carcinoma
Lung Neoplasms
Neoplasms
Carcinoma, Non-Small-Cell Lung
Carcinoma, Renal Cell
Squamous Cell Carcinoma of Head and Neck
Colorectal Neoplasms
Conditions: Keywords:
Solid tumors
metastatic
advanced
micro satellite stable
anti-PD-1
PF-07282690
LILRB12
sasanlimab
PD-1 resistance
PD-1 naive
PDx resistance
PDxnaive
Carcinoma, Non-Small Cell Lung
Non-Small Cell Lung Cancer
Non-Small Cell Lung Carcinoma
Non-Small-Cell Lung Carcinoma
Nonsmall Cell Lung Cancer
Colorectal Cancer
Colorectal Neoplasms
Colorectal Carcinoma
Colorectal Tumors
Renal Cell Carcinoma
Kidney Neoplasms
Rectal Disease
Neoplasms, Colorectal
Malignant Melanoma
Microsatellite Stable Colorectal Cancer (MSS CRC)
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
PF-07826390
Description:
PF-07826390 is a novel, fully humanized bispecific IgG1 that targets the leukocyte
immunoglobulin-like receptor, LILRB1 and LILRB2 (B1 and B2) cell-surface receptors
Arm group label:
Part 1A: PF-07826390 Monotherapy
Arm group label:
Part 1B: PF-07826390 + sasanlimab
Arm group label:
Part 2A (Arm 1): PF-07826390 + sasanlimab
Arm group label:
Part 2A (Arm 2): PF-07826390 + sasanlimab
Arm group label:
Part 2A (Arm 3): PF-07826390 + sasanlimab
Arm group label:
Part 2B: PF-07826390
Arm group label:
Part 2C: PF-07826390 + SOC
Other name:
LILRB1/2
Intervention type:
Biological
Intervention name:
sasanlimab
Description:
A monoclonal antibody that blocks the interaction between PD-1 and PD-L1/L2
Arm group label:
Part 1B: PF-07826390 + sasanlimab
Arm group label:
Part 2A (Arm 1): PF-07826390 + sasanlimab
Arm group label:
Part 2A (Arm 2): PF-07826390 + sasanlimab
Arm group label:
Part 2A (Arm 3): PF-07826390 + sasanlimab
Other name:
PF-06801591
Intervention type:
Other
Intervention name:
SOC (anti-PD-1 + platinum -based chemo)
Description:
Standard of Care (anti-PD-1 + platinum -based chemo)
Arm group label:
Part 2C: PF-07826390 + SOC
Summary:
The purpose of this study is to learn about the:
- safety (the effect of the study medicine on the participant's body),
- effects of the study medicine alone or in combination with sasanlimab -
- the best amount of the study medicine.
This study is seeking participants who have solid tumors (An abnormal mass of tissue)
that:
- have advanced (cancer that does not disappear or stay away with treatment) or
- are metastatic (has spread to other parts of the body).
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.
- Renal Cell Carcinoma (RCC): This is a cancer that starts in the kidney.
All participants in this study will receive the study medication (PF-07826390) as an IV
infusion (given directly into a vein) at the study once every four weeks in 28 day
cycles.
The study participants depending on the group enrolled in, will receive the study
medication (PF-07826390 alone or in combination with other anti-cancer medications
(sasanlimab). Sasanlimab is given as a shot under the skin every 4 weeks.
Participants can continue to take the study medication (PF-07826390) 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,
participants will have a study visit every week. The participants after stopping the
study medicine (at about 2 years) will be followed for another two years to see how the
participants are doing.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Histological or cytological diagnosis of advanced, unresectable, and/or metastatic
or relapsed/refractory solid tumor
- Part 1A: Participants with solid tumors where anti-PD-(L)1 is an established
treatment. Participants must have progressed on or following prior anti-PD-(L)1
therapy if approved, available, tolerable, and eligible
- Part 1B: Participants either meeting Part 1A criterion, or participants with "cold"
solid tumors where anti-PD-(L)1 therapy is not an established treatment
- Part 2: Participants with NSCLC (2A Arm 1 and 2B) must have received platinum-based
chemotherapy and anti-PD-(L)1 or have intolerability to or refusal of standard
therapies. Participants with NSCLC who have not been previously treated with a prior
anti-pd-(L) will be enrolled in Part 2C.
- Participants with MSS CRC (Part 2A Arm 2) must have received fluoropyrimidine-,
oxaliplatin, and irinotecan-based chemotherapy, an anti-VEGF agent and anti-EGFR
inhibitor (if RAS wildtype) and/or other molecularly targeted therapy if
appropriate. Participants with RCC (Part 2A Arm 3) must have received prior tyrosine
kinase inhibitor (TKI), anti-PD-(L)1 (if not receiving anti-PD-1 on protocol),
anti-CTLA-4 (optional), hypoxia-inducible factor 2 alpha (HIF2a) inhibitor, or mTOR
inhibitor or have documented intolerance to the standard therapy.
- At least 1 measurable lesion based on RECIST 1.1 that has not been previously
irradiated (Part 1 exceptions permitted after review and approval)
- Able to provide pre-treatment (and optional on-treatment) tumor tissue
Exclusion Criteria:
- Treatment with any systemic anticancer therapy within 4 weeks or 5 half-lives
(whichever is shorter) prior to planned first dose
- Active or history of clinically significant autoimmune disease or other medical
condition that required chronic systemic immunosuppressive therapy within recent 2
years
- Prior treatment with another LILRB1 (ILT2), LILRB2 (ILT4), and/or LILRB1/2 (B1 and
B2) antagonist antibodies or pathway targeting agents, including HLA conformers and
HLA-G antibodies.
- Lack of adequate organ (bone marrow, renal, liver) function
- History of severe immune-mediated adverse event or cytokine release syndrome that
was considered related to prior immune modulatory therapy that required
immunosuppressive therapy
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beverly Hills Cancer Center
Address:
City:
Beverly Hills
Zip:
90211
Country:
United States
Status:
Recruiting
Facility:
Name:
California Cancer Associates for Research and Excellence
Address:
City:
Encinitas
Zip:
92024
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
California Cancer Associates for Research and Excellence, Inc. (cCARE)
Address:
City:
San Marcos
Zip:
92069
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Florida Cancer Specialists
Address:
City:
Orlando
Zip:
32827
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
Sarah Cannon Research Institute at Florida Cancer Specialists
Address:
City:
Orlando
Zip:
32827
Country:
United States
Status:
Not yet recruiting
Facility:
Name:
South Texas Accelerated Research Therapeutics (START)
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Start date:
September 6, 2024
Completion date:
February 14, 2030
Lead sponsor:
Agency:
Pfizer
Agency class:
Industry
Source:
Pfizer
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06546553
https://pmiform.com/clinical-trial-info-request?StudyID=C5321001
