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

CytomX

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Breast Cancer; Solid Tumor, Adult; Non Small Cell Lung Cancer; Ovarian Cancer; Head and Neck Cancer

Treatments: Drug: CX-2009

Study type: Interventional

Funder types: Industry

Identifiers

NCT03149549

CTMX-M-2009-001

Details and patient eligibility

About

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

Enrollment: 99 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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99 participants in 4 patient groups

CX-2009 Monotherapy: 21-Day Dosing Regimen-Escalation

Experimental group

Description:

Dose escalation and determination

Treatment:

Drug: CX-2009

CX-2009 Monotherapy: 21-Day Dosing Regimen-Determination

Experimental group

Description:

Additional enrollment into previously cleared monotherapy dose levels

Treatment:

Drug: CX-2009

CX-2009 Monotherapy: 21-Day Dosing Regimen-Expansion

Experimental group

Description:

Dose expansion

Treatment:

Drug: CX-2009

CX-2009 Monotherapy: 14-Day Dosing Regimen-Expansion

Experimental group

Description:

Dose escalation and determination in selected tumor types

Treatment:

Drug: CX-2009