Colorectal Cancer Clinical Trial
Official title:
A PHASE 1A/B OPEN-LABEL MASTER STUDY OF PF-07799544 AS A SINGLE-AGENT AND IN COMBINATION WITH OTHER TARGETED AGENTS IN PARTICIPANTS WITH ADVANCED SOLID TUMORS
The purpose of this clinical trial is to learn the safety and effects of the study medicine (PF-07799544) administered as a single agent and in combination with other study medications in people with solid tumors. This study is seeking participants who have an advanced solid tumor for which the available treatments are no longer effective in controlling their cancer. All participants in this study will receive PF-07799544. PF-07799544 comes as a tablet to take by mouth daily (initially 2 times per day, but this could change to once daily or another frequency). Depending on the part of the study, participants may also receive another study medicine. - In the first part of the study, people with melanoma or other solid tumors may also receive encorafenib. Encorafenib comes as a capsule and is taken once per day. - In the second part of the study, people with melanoma or other cancers with abnormalities in a gene called "BRAF" will receive PF-07799544 with other study medicines (for example, PF-07799933). Participants may receive the study medicines for about 2 years. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
Status | Recruiting |
Enrollment | 124 |
Est. completion date | September 28, 2028 |
Est. primary completion date | March 28, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 16 Years and older |
Eligibility | Inclusion Criteria: - Diagnosis of advanced/metastatic solid tumor including primary brain tumor for monotherapy phase 1a dose escalation - Disease progressed during/following last prior treatment and no satisfactory alternative treatment options for monotherapy phase 1a dose escalation - For Substudy B, histological or cytological diagnosis of advanced/metastatic melanoma - For Substudy C, unresectable or adv/metastatic solid tumor progressed on, or with demonstrated intolerance to SOC, excluding melanoma, - For Substudy B and C, measurable disease by RECIST version 1.1 - For Substudy B, evidence of a BRAF V600 mutation or BRAF Class II/III alteration in tumor tissue and/or blood - For Substudy C, evidence of a BRAF founder alteration (non-V600 Class II/III BRAF alteration) Exclusion Criteria: - Brain metastasis larger than 4 cm - History or current evidence of retinal vein occlusion (RVO) or concurrent neuromuscular disorder associated with elevated creatine kinase (CK) |
Country | Name | City | State |
---|---|---|---|
Canada | Cross Cancer Institute | Edmonton | Alberta |
Canada | Jewish General Hospital | Montreal | Quebec |
Canada | McGill University Health Centre | Montréal | Quebec |
Canada | The Ottawa Hospital - General Campus | Ottawa | Ontario |
Canada | Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus | Quebec City | Quebec |
Canada | Princess Margaret Cancer Centre | Toronto | Ontario |
Canada | Sunnybrook Research Institute | Toronto | Ontario |
United States | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
United States | Cleveland Clinic Taussig Cancer Center Investigational Pharmacy | Cleveland | Ohio |
United States | Brigitte Harris Cancer Pavilion | Detroit | Michigan |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Highlands Oncology Group | Fayetteville | Arkansas |
United States | Highlands Oncology Group, PA | Fayetteville | Arkansas |
United States | University of Texas MD Anderson Cancer Center | Houston | Texas |
United States | Columbia University Irving Medical Center | New York | New York |
United States | CUIMC Research Pharmacy | New York | New York |
United States | Providence Cancer Institute Franz Clinic | Portland | Oregon |
United States | Providence Portland Medical Center | Portland | Oregon |
United States | Highlands Oncology Group | Rogers | Arkansas |
United States | Highlands Oncology Group, PA | Rogers | Arkansas |
United States | Fred Hutchinson Cancer Center | Seattle | Washington |
United States | University of Washington Medical Center | Seattle | Washington |
United States | Highlands Oncology | Springdale | Arkansas |
United States | Highlands Oncology Group | Springdale | Arkansas |
United States | Highlands Oncology Group, PA | Springdale | Arkansas |
United States | Florida Eye Center at Florida Medical Clinic | Tampa | Florida |
United States | Moffitt Cancer Center | Tampa | Florida |
United States | Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center | Tampa | Florida |
United States | Moffitt McKinley Hospital | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with dose limiting toxicities (DLTs) Phase 1a monotherapy and Phase 1b combination therapy dose escalation | DLTs will be evaluated during the first cycle (21 days) as a single agent (phase 1a monotherapy) or in combination with other agents (phase 1b dose escalation) | Cycle 1 (21 days) | |
Primary | Overall response rate (ORR) (phase 1b expansion) | Response will be evaluated via radiographical tumor assessments by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) | Baseline to 2 years | |
Primary | Number of participants with treatment-emergent adverse events (AEs) (phase 1a and 1b dose escalation phases) | AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy | Baseline to 28 days after last dose of study medication | |
Primary | Number of participants with clinically significant change from baseline in laboratory abnormalities (phase 1a and phase 1b dose escalation phase) | Laboratory abnormalities as characterized by type, frequency, severity, and timing. | Baseline to 28 days after last dose of study treatment | |
Primary | Number of participants with clinically significant change from baseline in vital sign abnormalities (phase 1a and phase 1b dose escalation phase) | Vital sign abnormalities as characterized by type, frequency, severity, and timing. | Baseline to 28 days after last dose of study treatment | |
Primary | Number of participants with clinically significant change from baseline in physical exam abnormalities (phase 1a and phase 1b dose escalation phase) | Physical exam abnormalities as as graded by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. | Baseline to 28 days after last dose of study treatment | |
Secondary | Number of participants with treatment-emergent adverse events (AEs) | AEs as characterized by type, frequency, severity, timing, seriousness, and relationship to study therapy | Baseline to 2 years | |
Secondary | Number of participants with clinically significant change from baseline in laboratory abnormalities | Laboratory abnormalities as characterized by type, frequency, severity, and timing. | Baseline to 2 years | |
Secondary | Number of participants with clinically significant change from baseline in vital sign abnormalities | Vital sign abnormalities as characterized by type, frequency, severity, and timing. | Baseline to 2 years | |
Secondary | PK parameters of PF-07799544, Single dose, maximum observed concentration (Cmax) | PK parameters of PF-07799544, Single dose, Cmax | Baseline to 2 years | |
Secondary | PK parameters of PF-07799544, Single dose, time to maximum plasma concentration (Tmax) | PK parameters of PF-07799544, Single dose, Tmax | Baseline to 2 years | |
Secondary | PK parameters of PF-07799544, Single dose, area under the plasma concentration-time curve from time 0 to the last time point of quantifiable concentration (AUClast) | PK parameters of PF-07799544, Single dose, AUClast | Baseline to 2 years | |
Secondary | PK parameters of PF-07799544, Single dose, area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf) | PK parameters of PF-07799544, Single dose, AUCinf | Baseline to 2 years | |
Secondary | PK parameters of PF-07799544, Single dose, terminal elimination half life (t½) | PK parameters of PF-07799544, Single dose, t½ | Baseline to 2 years | |
Secondary | PK parameters of PF-07799544, Single dose, apparent oral clearance (CL/F) | PK parameters of PF-07799544, Single dose, CL/F | Baseline to 2 years | |
Secondary | PK parameters of PF-07799544, Single dose, apparent volume of distribution (Vz/F) | PK parameters of PF-07799544, Single dose, Vz/F | Baseline to 2 years | |
Secondary | PK parameters of PF-07799544, Multiple dose, maximum observed concentration (Cmax) | PK parameters of PF-07799544, Multiple dose, Cmax | Baseline to 2 years | |
Secondary | PK parameters of PF-07799544, Multiple dose, time to maximum plasma concentration (Tmax) | PK parameters of PF-07799544, Multiple dose, Tmax | Baseline to 2 years | |
Secondary | PK parameters of PF-07799544, Multiple dose, area under the plasma concentration-time curve over the dosing interval (AUCt) | PK parameters of PF-07799544, Multiple dose, AUCt | Baseline to 2 years | |
Secondary | PK parameters of PF-07799544, Multiple dose, terminal elimination half life (t½) | PK parameters of PF-07799544, Multiple dose, t½ | Baseline to 2 years | |
Secondary | PK parameters of PF-07799544, Multiple dose, apparent oral clearance (CL/F) | PK parameters of PF-07799544, Multiple dose, CL/F | Baseline to 2 years | |
Secondary | PK parameters of PF-07799544, Multiple dose, apparent volume of distribution (Vz/F) | PK parameters of PF-07799544, Multiple dose, Vz/F | Baseline to 2 years | |
Secondary | PK parameters of PF-07799933, Single dose, maximum observed concentration (Cmax) | PK parameters of PF-07799933, Single dose, Cmax | Baseline to 2 years | |
Secondary | PK parameters of PF-07799933, Single dose, time to maximum plasma concentration (Tmax) | PK parameters of PF-07799933, Single dose, Tmax | Baseline to 2 years | |
Secondary | PK parameters of PF-07799933, Single dose, area under the plasma concentration-time curve from time 0 to the last time point of quantifiable concentration (AUClast) | PK parameters of PF-07799933, Single dose, AUClast | Baseline to 2 years | |
Secondary | PK parameters of PF-07799933, Single dose, area under the plasma concentration-time curve from time 0 extrapolated to infinity (AUCinf) | PK parameters of PF-07799933, Single dose, AUCinf | Baseline to 2 years | |
Secondary | PK parameters of PF-07799933, Single dose, terminal elimination half life (t½) | PK parameters of PF-07799933, Single dose, t½ | Baseline to 2 years | |
Secondary | PK parameters of PF-07799933, Single dose, apparent oral clearance (CL/F) | PK parameters of PF-07799933, Single dose, CL/F | Baseline to 2 years | |
Secondary | PK parameters of PF-07799933, Single dose, apparent volume of distribution (Vz/F) | PK parameters of PF-07799933, Single dose, Vz/F | Baseline to 2 years | |
Secondary | PK parameters of PF-07799933, Multiple dose, maximum observed concentration (Cmax) | PK parameters of PF-07799933, Multiple dose, Cmax | Baseline to 2 years | |
Secondary | PK parameters of PF-07799933, Multiple dose, time to maximum plasma concentration (Tmax) | PK parameters of PF-07799933, Multiple dose, Tmax | Baseline to 2 years | |
Secondary | PK parameters of PF-07799933, Multiple dose, area under the plasma concentration-time curve over the dosing interval (AUCt) | PK parameters of PF-07799933, Multiple dose, AUCt | Baseline to 2 years | |
Secondary | PK parameters of PF-07799933, Multiple dose, terminal elimination half life (t½) | PK parameters of PF-07799933, Multiple dose, t½ | Baseline to 2 years | |
Secondary | PK parameters of PF-07799933, Multiple dose, apparent oral clearance (CL/F) | PK parameters of PF-07799933, Multiple dose, CL/F | Baseline to 2 years | |
Secondary | PK parameters of PF-07799933, Multiple dose, apparent volume of distribution (Vz/F) | PK parameters of PF-07799933, Multiple dose, Vz/F | Baseline to 2 years | |
Secondary | ORR (phase 1a and phase 1b dose escalation) | ORR as assessed using the RECIST version 1.1. | Baseline to 2 years | |
Secondary | Duration of response overall and in CNS | Baseline to 2 years | ||
Secondary | Intracranial response (phase 1b Part 2) | Intracranial response by RECIST version 1.1 (for brain metastases) | Baseline to 2 years | |
Secondary | PFS | Baseline to 2 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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