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

Pfizer

Status and phase: Terminated; Phase 1

Conditions: Gastrointestinal Tumors; Esophageal Adenocarcinomas; Colorectal Adenocarcinomas; Gastric Adenocarcinomas

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT04171141

GUCY2C (Other Identifier)

C3861001

Details and patient eligibility

About

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

Full description

This is a Phase 1, open-label, multi-center, non-randomized, multiple dose, safety, tolerability, pharmacokinetic, and pharmacodynamic 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). In Part 1A, successive cohorts of patients will receive escalating doses of PF-007062119 and then in dose finding (Part 1B) with PF-07062119 in combination with anti-PD-1 and in combination with anti-VEGF. This study contains 2 parts, dose escalation with single agent (Part 1A) and then dose finding with PF-007062119 in combination with ant-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).

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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79 participants in 7 patient groups

Dose Escalation

Experimental group

Description:

Single Agent Dose Escalation

Treatment:

Drug: PF-07062119

Dose Finding Anti-PD-1 Combination

Experimental group

Description:

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

Treatment:

Drug: Anti-PD1

Drug: PF-07062119

Dose Finding anti-VEGF Combination

Experimental group

Description:

Part 1B PF-07062119 plus anti-VEGF

Treatment:

Drug: Anti-VEGF

Drug: PF-07062119

Dose Expansion Arm A

Experimental group

Description:

PF-07062119 as a Single Agent in CRC

Treatment:

Drug: PF-07062119

Dose Expansion Arm B

Experimental group

Description:

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

Treatment:

Drug: PF-07062119

Dose Expansion Arm C

Experimental group

Description:

PF-07062119 in Combination with anti-VEGF in CRC

Treatment:

Drug: Anti-VEGF

Drug: Anti-PD1

Drug: PF-07062119

Dose Expansion Arm D

Experimental group

Description:

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

Treatment:

Drug: Anti-VEGF

Drug: Anti-PD1

Drug: PF-07062119