Clinical trial · Interventional
Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.
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
NCT04171141CI-TRIAL-00084792terminatedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was terminated due to strategic considerations and not due to safety.
Summary
Brief summary (as posted)
A phase 1, open-label, dose escalation and expansion study of PF-07062119 in patients with selected advanced or metastatic gastrointestinal tumors
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Adenocarcinomas | — | UNRESOLVED | — |
| Esophageal Adenocarcinomas | — | UNRESOLVED | — |
| Gastric Adenocarcinomas | — | UNRESOLVED | — |
| Gastrointestinal Tumors | Digestive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-PD1 | Drug | — | UNRESOLVED |
| Anti-VEGF | Drug | Bevacizumab | ALIAS |
| PF-07062119 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (7)
- type
- EXPERIMENTAL
- label
- Dose Escalation
- description
- Single Agent Dose Escalation
- interventionNames
- Drug: PF-07062119
- type
- EXPERIMENTAL
- label
- Dose Finding Anti-PD-1 Combination
- description
- Part 1B PF-07062119 plus anti-PD-1
- interventionNames
- Drug: PF-07062119
- Drug: Anti-PD1
- type
- EXPERIMENTAL
- label
- Dose Finding anti-VEGF Combination
- description
- Part 1B PF-07062119 plus anti-VEGF
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.