Clinical trial

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

Name

C3861001

Description

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

Trial arms

Trial start

2019-11-19

Estimated PCD

2023-11-28

Trial end

2023-11-28

Status

Terminated

Phase

Early phase I

Treatment

PF-07062119

Arms:

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

Anti-PD1 PF-06801591

Arms:

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

Anti-VEGF

Anti-VEGF IV (bevacizumab)

Arms:

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

Size

Primary endpoint

Number of participants with Dose-limiting toxicities (DLT) in Cycle 1

Baseline up to 28 days (or 42 days as applicable)

Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities

Baseline up to approximately 24 months

Duration of Adverse Events (AEs)

Baseline up to approximately 24 months

Number of Participants With Adverse Events (AEs) According to Severity

Baseline up to approximately 24 months

Number of Participants With Adverse Events (AEs) According to Seriousness

Baseline up to up to approximately 24 months

Number of Participants With Adverse Events (AEs) by Relationship

Baseline up to approximately 24 months

Objective Response - Number of Participants With Objective Response for Dose Expansion (Part 2)

Baseline (1st dosing) up to approximately 24 months

Eligibility criteria

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

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 79, 'type': 'ACTUAL'}}

Updated at

2024-03-07

1 organization

3 products

4 indications

Organization

Pfizer

Product

PF-07062119

Indication

Gastrointestinal Tumors

Indication