PROCLAIM-CX-072: A Trial to Find Safe and Active Doses of an Investigational Drug CX-072 for Patients With Solid Tumors or Lymphomas

Lymphoma Clinical Trial

Official title:

An Open-Label, Dose-Finding and Proof of Concept Study of the PD-L1 Probody™ Therapeutic , CX-072, as Monotherapy and in Combination With Yervoy (Ipilimumab) or With Zelboraf (Vemurafenib) in Subjects With Advanced or Recurrent Solid Tumors or Lymphomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03013491
• Other study ID #: CTMX-M-072-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2017
• Est. completion date: October 6, 2021

Study information

• Verified date: February 2022
• Source: CytomX Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this first-in-human study of CX-072 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-072 administered intravenously (IV) as a single agent or in combination with ipilimumab or vemurafenib in adult subjects with advanced or recurrent solid tumors or lymphomas. PROCLAIM-CX-072: PRObody CLinical Assessment In Man CX-072 clinical trial

CX-072 is a Probody™ therapeutic directed against PD-L1 (programmed cell death ligand 1). Probody therapeutics are proteolytically-activatable antibodies (Abs) designed to widen the therapeutic index by minimizing drug interaction with normal tissue while retaining anti-tumor activity. Probody therapeutics are "masked" to attenuate binding to target in healthy tissue but can become "unmasked" in the tumor microenvironment by tumor-specific protease activity.

PROBODY is a trademark of CytomX Therapeutics, Inc.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 6, 2021
• Est. primary completion date: October 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically confirmed diagnosis of metastatic or advanced unresectable tumors that progressed on standard therapy

2. Agreement to provide mandatory archival tissue or fresh biopsy.

3. At least 18 years of age.

Exclusion Criteria:

1. Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.

2. History of severe allergic or anaphylactic reactions to human monoclonal antibody therapy or known hypersensitivity to any Probody therapeutic.

3. Active or history of uveal, mucosal, or ocular melanoma. Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related illness, chronic hepatitis B or C.

4. History of or current active autoimmune diseases, including but not limited to inflammatory bowel diseases, rheumatoid arthritis, autoimmune thyroiditis, autoimmune hepatitis, systemic sclerosis, systemic lupus erythematosus, autoimmune vasculitis, autoimmune neuropathies, or type 1 insulin dependent diabetes mellitus.

5. History of syndrome or medical condition(s) that requires systemic steroids (> 10 mg daily prednisone equivalents) or immunosuppressive medications.

6. History of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant.

7. Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug.

8. Major surgery (requiring general anesthesia) within 3 months or minor surgery (excluding biopsies conducted with local/topical anesthesia) or gamma knife treatment within 14 days (with adequate healing) of administration of any study drug.

Related Conditions & MeSH terms

• Lymphoma
• Solid Tumor

Intervention

Drug:
• CX-072

• ipilimumab

• vemurafenib

Locations

Country	Name	City	State
Netherlands	PROCLAIM Investigative Site	Amsterdam
Netherlands	PROCLAIM Investigative Site	Groningen
Netherlands	PROCLAIM Investigative Site	Rotterdam
Poland	PROCLAIM Investigative Site	Katowice
Spain	PROCLAIM Investigative Site	Barcelona
Spain	PROCLAIM Investigative Site	Barcelona
Spain	PROCLAIM Investigative Site	Madrid
Spain	PROCLAIM Investigative Site	Madrid
Spain	PROCLAIM Investigative Site	Pamplona	Navarre
Spain	PROCLAIM Investigative Ssite	Valencia
Ukraine	PROCLAIM Investigative Site	Dnepropetrovsk
United Kingdom	PROCLAIM Invetigative Site	Glasgow
United Kingdom	PROCLAIM Investigative Site	London
United Kingdom	PROCLAIM Investigative Site	Manchester
United Kingdom	PROCLAIM Investigative Site	Newcastle upon Tyne
United States	PROCLAIM Investigative Site	Boston	Massachusetts
United States	PROCLAIM Investigative Site	Chicago	Illinois
United States	PROCLAIM Investigative Site	Dallas	Texas
United States	PROCLAIM Investigative Site	Detroit	Michigan
United States	PROCLAIM Investigative Site	Fairfax	Virginia
United States	PROCLAIM Investigative Site	Houston	Texas
United States	PROCLAIM Investigative Site	Indianapolis	Indiana
United States	PROCLAIM Investigative Site	Los Angeles	California
United States	PROCLAIM Investigative Site	Los Angeles	California
United States	PROCLAIM Investigative Site	Madison	Wisconsin
United States	PROCLAIM Investigative Site	Nashville	Tennessee
United States	PROCLAIM Investigative Site	New Haven	Connecticut
United States	PROCLAIM Investigative Site	New York	New York
United States	PROCLAIM Investigative Site	New York	New York
United States	PROCLAIM Investigative Site	New York	New York
United States	PROCLAIM Investigative Site	Portland	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
CytomX Therapeutics

Countries where clinical trial is conducted

United States,  Netherlands,  Poland,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of subjects experiencing a dose limiting toxicity at various dose levels when given multiple doses of CX-072 as a monotherapy or in combination with ipilimumab or vemurafenib		28 days (dose limiting toxicity period)
Secondary	The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given multiple doses of CX-072 as a monotherapy or in combination with ipilimumab or vemurafenib		2 Years