Study to Test the Safety and Tolerability of PF-07062119 in Patients With Selected Advanced or Metastatic Gastrointestinal Tumors.

NCT04171141 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: C3861001GUCY2C
• Study Type: interventional
• Target: 79
• Locations: 3 countries
• Sites: 19

Brief Summary

A phase 1, open-label, dose escalation and expansion study of PF-07062119 in patients with selected advanced or metastatic gastrointestinal tumors

Conditions

Gastrointestinal Tumors; Colorectal Adenocarcinomas; Gastric Adenocarcinomas; Esophageal Adenocarcinomas

Keywords

Gastric cancer; Esophageal cancer; Colorectal cancer; Advanced esophageal cancer; Metastatic esophageal cancer; Advanced colorectal cancer; Metastatic gastric cancer; Advanced gastric cancer; Metastatic colorectal cancer; GUCY2c; Anti-PD1; Anti-VEGF; Measurable disease; PF-07062119; PF-06801591; Bevacizumab

Outcome Measures

Primary Outcomes (5)

• Number of Participants With Dose Limiting Toxicities (DLTs) Assessed Through Cycle 1

  Hematological DLTs: * Grade 3 neutropenia lasting \>5 days * Febrile neutropenia defined as an ANC \<1.0 x 10 ̂9/L with a single temperature of \>38.3°C, or a sustained temperature of ≥38°C, for more than 1 hour * Grade ≥3 Neutropenia with infection * Grade 3 Thrombocytopenia with Grade ≥2 (clinically significant) bleeding * any Grade 4 Thrombocytopenia * Anemia or Thrombocytopenia requiring transfusion Non Hematological DLTs: * Grade ≥3 fatigue lasting ≥7 days * for participants with liver, bone, or lung metastasis, an AST or ALT increase \>8 x ULN or ALP \>10 x ULN; * confirmed DILI meeting Hy's law criteria * Grade 3 Vomiting or Diarrhea lasting ≥3 days despite adequate treatment/other supportive care * Grade 4 Vomiting or Diarrhea * Grade ≥3 CRS regardless of duration * Grade ≥3 QTcF prolongation irrespective of duration * any death not clearly due to underlying disease or extraneous causes Clinically important/persistent toxicities were DLTs reviewed by investigators and sponsor.

  28 Days

• Number of Participants With All-Causality Treatment-Emergent Adverse Events (TEAEs),Treatment-Emergent Serious Adverse Events (TESAEs), Maximum Grade 3 or 4 and 5 TEAEs

  An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect, etc. Treatment-emergent events were with onset date occurring during the on-treatment period. AEs were documented and recorded at each visit using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0.

  4 Years

• Number of Participants With Treatment-Related TEAEs, TESAEs, Maximum Grade 3 or 4 and 5 TEAEs

  An AE was any untoward medical occurrence in a participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: resulted in death; was life threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent disability/incapacity; was a congenital anomaly/birth defect, etc. Treatment-emergent events were with onset date occurring during the on-treatment period. Relatedness to study treatment was determined by the investigator. AEs were documented and recorded at each visit using the NCI CTCAE version 5.0. Severe AEs were classified as Grade 3; life-threatening consequences and urgent intervention indicated were classified as Grade 4; deaths related to AEs were classified as Grade 5.

  4 Years

• Number of Participants With CTCAE Grade 3 or 4 Hematology Laboratory Abnormalities

  The investigator reviewed the laboratory report, documented this review, and recorded any clinically relevant changes occurring during the study in the AE section of the CRF. Clinically significant abnormal laboratory findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. CTCAE version 5.0 was applied.

  4 Years

• Number of Participants With CTCAE Grade 3 or 4 Chemistry Laboratory Abnormalities

  The investigator reviewed the laboratory report, documented this review, and recorded any clinically relevant changes occurring during the study in the AE section of the case report form (CRF). Clinically significant abnormal laboratory findings were those which were not associated with the underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition. CTCAE version 5.0 was applied.

  4 Years

Secondary Outcomes (15)

• Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Maximum Concentration (Cmax) - Priming Cohorts

  Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1

• Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Cmax - Non-Priming Cohorts

  Cycle 1 Day 1 and Cycle 4 Day 1

• Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Time to Achieve Cmax (Tmax) - Priming Cohorts

  Cycle 1 Day 1, Cycle 1 Day 15 and Cycle 4 Day 1

• Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Tmax - Non-Priming Cohorts

  Cycle 1 Day 1 and Cycle 4 Day 1

• Cycle 1 and Cycle 4 PF-07062119 PK Parameters: Area Under the Serum Concentration-Time Profile From Time 0 to Time Tau, the Dosing Interval (AUCtau) - Priming Cohorts

  Cycle 1 Day 1 and Cycle 4 Day 1

Study Arms (7)

Dose Escalation

EXPERIMENTAL

Single Agent Dose Escalation

Drug: PF-07062119

Dose Finding Anti-PD-1 Combination

EXPERIMENTAL

Part 1B PF-07062119 plus anti-PD-1

Drug: PF-07062119; Drug: Anti-PD1

Dose Finding anti-VEGF Combination

EXPERIMENTAL

Part 1B PF-07062119 plus anti-VEGF

Drug: PF-07062119; Drug: Anti-VEGF

Dose Expansion Arm A

EXPERIMENTAL

PF-07062119 as a Single Agent in CRC

Drug: PF-07062119

Dose Expansion Arm B

EXPERIMENTAL

PF-07062119 in Combination with anti-PD-1 in CRC

Drug: PF-07062119

Dose Expansion Arm C

EXPERIMENTAL

PF-07062119 in Combination with anti-VEGF in CRC

Drug: PF-07062119; Drug: Anti-PD1; Drug: Anti-VEGF

Dose Expansion Arm D

EXPERIMENTAL

PF-07062119 in Combination with either anti-PD-1 or anti-VEGF in various Tumor Types

Drug: PF-07062119; Drug: Anti-PD1; Drug: Anti-VEGF

Interventions

PF-07062119 DRUG

PF-07062119

Dose Escalation; Dose Expansion Arm A; Dose Expansion Arm B; Dose Expansion Arm C; Dose Expansion Arm D; Dose Finding Anti-PD-1 Combination; Dose Finding anti-VEGF Combination

Anti-PD1 DRUG

Anti-PD1 PF-06801591

Dose Expansion Arm C; Dose Expansion Arm D; Dose Finding Anti-PD-1 Combination

Anti-VEGF DRUG

Anti-VEGF IV (bevacizumab)

Dose Expansion Arm C; Dose Expansion Arm D; Dose Finding anti-VEGF Combination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (19)

City of Hope (City of Hope National Medical Center, City of Hope Medical Center)

Duarte, California, 91010, United States

Location

City of Hope IDS Pharmacy

Duarte, California, 91010, United States

Location

UCLA Department of Medicine: Hematology-Oncology

Los Angeles, California, 90055, United States

Location

UCLA Hematology Oncology - Santa Monica

Santa Monica, California, 90404, United States

Location

University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)

Aurora, Colorado, 80045, United States

Location

University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)

Aurora, Colorado, 80045, United States

Location

University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)

Aurora, Colorado, 80045, United States

Location

START Midwest

Grand Rapids, Michigan, 49546, United States

Location

Memorial Sloan Kettering Cancer Center Rockefeller Outpatient Pavillion

New York, New York, 10022, United States

Location

Evelyn H. Lauder Breast and Imaging Center

New York, New York, 10065, United States

Location

Memorial Sloan Kettering Cancer Center - Main Campus

New York, New York, 10065, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Christus Santa Rosa Hospital

San Antonio, Texas, 78229, United States

Location

NEXT Oncology

San Antonio, Texas, 78229, United States

Location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location

The Royal Melbourne Hospital

Parkville, Victoria, 3050, Australia

Location

National Cancer Center Hospital East

Kashiwa, Chiba, 277-8577, Japan

Location

National Cancer Center Hospital

Chuo-ku, Tokyo, 104-0045, Japan

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Digestive System Neoplasms; Stomach Neoplasms; Esophageal Neoplasms; Colorectal Neoplasms

Interventions

spartalizumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Limitations and Caveats

This study was terminated on 10 October 2023. Study termination was due to a strategic decision but not any safety concerns or requests from any regulatory authorities. This BR presents the study results of dose escalation phase (Part 1) collected by the study completion date (28-Nov-2023). Dose expansion phase (Part 2) of the study was not conducted due to the study termination.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquiries@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 20, 2019
• Study Start: November 19, 2019
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: January 16, 2025
• Results First Posted: January 16, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (15); AU (2); JP (2)