PROCLAIM-CX-2009: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2009 for Patients With Selected Solid Tumors

Phase 1

Terminated

• Conditions: Solid Tumor, Adult; Ovarian Cancer; Breast Cancer; Head and Neck Cancer; Non Small Cell Lung Cancer
• Interventions: Drug: CX-2009

• Registration Number: NCT03149549
• Lead Sponsor: CytomX Therapeutics

Brief Summary

The purpose of this first-in-human study of CX-2009 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2009 in adult subjects with metastatic or locally advanced unresectable solid tumors. PROCLAIM: PRObody CLinical Assessment In Man CX-2009 clinical trial 001

PROBODY is a trademark of CytomX Therapeutics, Inc

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-04
• Study First Submitted QC: 2017-05-09
• Study First Posted: 2017-05-11
• Study Start: 2017-06-01
• Primary Completion: 2020-09-10
• Study Completion: 2020-09-10
• Results First Submitted: 2021-10-01
• Status Verified: 2024-01
• Results First Submitted QC: 2024-01-03
• Last Update Submitted: 2024-01-03
• Results First Posted: 2024-01-05
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

1. Histologically confirmed diagnosis of metastatic or locally advanced unresectable tumors
2. Patients demonstrating disease progression after treatment with available therapies that are known to confer clinical benefit, or who are intolerant to treatment,
3. Agreement to provide mandatory archival tissue or fresh biopsy.
4. At least 18 years of age.

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Exclusion Criteria

1. Active or chronic corneal disorder, history of corneal transplantation, active herpetic keratitis, and active ocular conditions requiring ongoing treatment/monitoring
2. Serious concurrent illness, including clinically relevant active infection
3. History of or current active autoimmune diseases
4. Significant cardiac disease such as recent myocardial infarction
5. History of multiple sclerosis or other demyelinating disease, Eaton-Lambert syndrome (para-neoplastic syndrome), history of hemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;
6. Non-healing wound(s) or ulcer(s) except for ulcerative lesions caused by the underlying neoplasm;
7. History of severe allergic or anaphylactic reactions to previous monoclonal antibody therapy;
8. Currently receiving anticoagulation therapy with warfarin;
9. Major surgery (requiring general anesthesia) within 3 months prior to dosing.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CX-2009 Monotherapy: 21-Day Dosing Regimen-Escalation	CX-2009	Dose escalation and determination
CX-2009 Monotherapy: 14-Day Dosing Regimen-Expansion	CX-2009	Dose escalation and determination in selected tumor types
CX-2009 Monotherapy: 21-Day Dosing Regimen-Determination	CX-2009	Additional enrollment into previously cleared monotherapy dose levels
CX-2009 Monotherapy: 21-Day Dosing Regimen-Expansion	CX-2009	Dose expansion

Primary Outcome Measures

Name	Time	Method
The Number of Subjects Experiencing a Dose Limiting Toxicity at Various Dose Levels When Given CX-2009 as a Monotherapy	21 days for the Q3W schedule, 28 days for the Q2W schedule	All AEs will be captured according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 and considered for assessment of DLTs as outlined by the criteria in Protocol Table 5.

Secondary Outcome Measures

Name	Time	Method
Subjects Experiencing Anti-cancer Activity (ORR) at Various Dose Levels When Given CX-2009 as a Monotherapy	Median total on-study follow-up of 18.4 weeks.	Efficacy will be assessed via objective response rate (ORR) by RECIST version 1.1. ORR is defined as the percentage of patients with complete response (CR) or partial response (PR) on two consecutive tumor assessments with scan dates at least 4 weeks apart according to RECIST (version 1.1, refer to SAP section 13.1.1). Complete criteria for RECIST 1.1 are provided as an appendix to the protocol.; \>; \> For as long as a subject continues follow-up for response in the study, CT/MRI/Tumor assessment are to be conducted every 8 (+/- 1) weeks from the first dose of CX 2009 with assessment for response per; \> RECIST Version 1.1

Trial Locations

Locations (26)

USC Norris Comprehensive Cancer Center; 🇺🇸 Los Angeles, California, United States

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Universitair Medisch Centrum Groningen; 🇳🇱 Groningen, Netherlands

Hospital Clinic Barcelona; 🇪🇸 Barcelona, Spain

Instituto Catalan de Oncologia - Hospital Duran i Reynals; 🇪🇸 Barcelona, Spain

Viriginia Cancer Specialists; 🇺🇸 Fairfax, Virginia, United States

Amsterdam UMC - Locatie VUmc; 🇳🇱 Amsterdam, Netherlands

Clinica Universidad de Navarra; 🇪🇸 Pamplona, Navarre, Spain

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

University of Wisconsin-Carbone Cancer Center; 🇺🇸 Madison, Wisconsin, United States

Northern Centre for Cancer Care; 🇬🇧 Newcastle Upon Tyne, United Kingdom

Centro Integral Oncologico Clara Campal; 🇪🇸 Madrid, Spain

Beatson, West of Scotland Cancer Centre; 🇬🇧 Glasgow, United Kingdom

Sarah Cannon Research Institute UK Limited; 🇬🇧 London, United Kingdom

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Columbia University College of Physicians & Surgeons, Columbia University; 🇺🇸 New York, New York, United States

New York University (NYU) Clinical Cancer Center; 🇺🇸 New York, New York, United States

Instituto Valenciano de Oncologia; 🇪🇸 Valencia, Spain

Yale University School of Medicine - Yale Cancer Center; 🇺🇸 New Haven, Connecticut, United States

Barbara Ann Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Providence Portland Medical Center; 🇺🇸 Portland, Oregon, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Huntsman Cancer Institute; 🇺🇸 Salt Lake City, Utah, United States

The Sarah Cannon Research Institute; 🇺🇸 Nashville, Tennessee, United States

Swedish Cancer Institute (SCI); 🇺🇸 Seattle, Washington, United States