Trial purpose
Cancer treatment
Tumor type
Multi-Cancer
Age
18+
Clinical summary
Summary
This is a non-randomised, multi-arm dose escalation and dose expansion study of PF-07062119 administered as a single agent in sequential dose levels, and then in combination with anti-programmed cell death-1 protein (anti-PD-1), and in combination with an anti-vascular endothelial growth factor (anti-VEGF). This study contains 2 parts, dose escalation with a single agent (Part 1A) and then dose finding with PF-07062119 in combination with anti-PD-1 and in combination with anti-VEGF (Part 1B), followed by dose expansion arms as a single agent and PF-07062119 in combination with anti-PD-1 and in combination with anti-VEGF (Part 2).
Conditions
This trial is treating people with colorectal, stomach and oesophageal cancers
Eligibility
Inclusion
- For Part 1 and Part 2, diagnosis of advanced/metastatic colorectal, gastric or esophageal adenocarcinoma that is resistant to standard therapy or for which no local regulatory approved standard therapy is available that would confer significant benefit.
- For Part 2, diagnosis of colorectal adenocarcinoma that is resistant to standard therapy or for which no standard therapy is available
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1
- Measurable disease or non-measurable disease and refractory to or intolerant of existing therapies (Part 1)
- Measurable disease as defined by RECIST 1.1 is required (Part 2)
Exclusion
- Known active uncontrolled or symptomatic Central Nervous System (CNS) metastases
- Other active malignancy within 3 years prior to randomization, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
- Major surgery or radiation within 3 weeks prior to study entry
- Last anti-cancer treatment within 4 weeks prior to study entry
- Active or history of clinically significant autoimmune disease that required systemic immunosuppressive medication
- Active or history of clinically significant gastrointestinal disease
- Participation in other studies involving investigational drug(s) within 2 weeks prior to study entry
- Pregnant or breastfeeding female patients
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You have been diagnosed with cancer, but have not received any treatment.
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Pfizer
Scientific Title
A PHASE 1 DOSE ESCALATION AND EXPANSION STUDY EVALUATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, PHARMACODYNAMICS AND ANTI TUMOR ACTIVITY OF PF-07062119 IN PATIENTS WITH ADVANCED GASTROINTESTINAL TUMORS
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