PROCLAIM-CX-2029: A Trial to Find Safe and Active Doses of an Investigational Drug CX-2029 for Patients With Solid Tumors or DLBCL

Head and Neck Cancer Clinical Trial

Official title:

A Phase 1-2, First-in-Human Study of CX-2029 in Adults With Metastatic or Locally Advanced Unresectable Solid Tumors or Diffuse Large B-cell Lymphomas (PROCLAIM-CX-2029)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03543813
• Other study ID #: CTMX-M-2029-001
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: June 15, 2018
• Est. completion date: June 1, 2023

Study information

• Verified date: January 2024
• 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-2029 is to characterize the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and antitumor activity of CX-2029 in adult subjects with metastatic or locally advanced unresectable solid tumors or diffuse large B-cell lymphoma (DLBCL). The antitumor activity of CX-2029 will be evaluated in subjects with head and neck squamous cell carcinoma (HNSCC), DLBCL, non-small cell lung cancer (NSCLC) (squamous cell histology only), or esophageal (esophageal adenocarcinoma [EAC], esophageal squamous cell carcinoma [ESCC], or gastroesophageal [GE] junction) cancer. PROCLAIM: PRObody CLinical Assessment In Man CX-2029 clinical trial 001 PROBODY is a trademark of CytomX Therapeutics, Inc

Description:

This is an open-label, Phase 1-2, first-in-human study for CX-2029 in subjects with metastatic or locally advanced unresectable solid tumors or Diffuse large B-cell lymphoma (DLBCL) without approved life-prolonging treatment options for their malignancy. The study is divided into 3 parts (arms), as follows: - Part A: Dose escalation and determination of the Maximum tolerated dose (MTD) and/or Recommended Phase 2 dose (RP2D) - Part B: Characterization of CX-2029 in the Tumor microenvironment (TME) in subjects with select tumor types using previously cleared dose levels from Part A - Part C: Expansions in select tumor types at the MTD/RP2D as established in Part A

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced unresectable tumors

2. Patients demonstrating disease progression after treatment with approved therapies that are known to confer life-prolonging benefit, or who are intolerant to or have declined treatment

3. Agreement to provide mandatory archival tissue or fresh biopsy

4. At least 18 years of age

5. For Arm A, histologically or cytologically confirmed metastatic or locally advanced unresectable solid tumor

6. For Arms B and C, histologically or cytologically confirmed metastatic or locally advanced unresectable HNSCC, DLBCL, NSCLC (squamous cell histology only), or esophageal (EAC, ESCC, or GE junction) cancer

7. Additional inclusion criteria may apply

Exclusion Criteria:

1. Neuropathy > Grade 1

2. Serious concurrent illness, including clinically relevant active infection

3. Clinically significant iron metabolism disorders (eg, sickle cell anemia)

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.

10. Hepatic impairment which is moderate (Child-Pugh B) or severe (Child-Pugh C)

11. Transfusion dependent anemia with transfusion dependency of =3 months

12. Use of iron chelators

13. Additional exclusion criteria may apply

Related Conditions & MeSH terms

• Diffuse Large B Cell Lymphoma
• Esophageal Cancer
• Head and Neck Cancer
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Non Small Cell Lung Cancer
• Solid Tumor, Adult

Intervention

Drug:
• CX-2029
CX-2029 Monotherapy

Locations

Country	Name	City	State
Korea, Republic of	Kangbuk Samsung Hospital	Seoul	Jongno-gu
Korea, Republic of	Seoul National University Hospital	Seoul	Jongno-gu
Korea, Republic of	Severance Hospital- Yonsei Cancer Center	Seoul	Seodaemun-gu
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Centro Integral Oncologico Clara Campal, START Madrid	Madrid
Spain	Hospital Universitario La Paz, Servicio de Oncología	Madrid
Spain	Hospital Universitario Quiron de Madrid	Madrid
United Kingdom	Beatson, West of Scotland Cancer Centre	Glasgow
United Kingdom	The Christie NHS Foundation Trust	Withington	Manchester Greater
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Barbara Ann Karmanos Cancer Institute	Detroit	Michigan
United States	California Cancer Associates for Research and Excellence	Encinitas	California
United States	Virginia Cancer Specialists	Fairfax	Virginia
United States	START Midwest	Grand Rapids	Michigan
United States	Forrest General Cancer Center	Hattiesburg	Mississippi
United States	MD Anderson Cancer Center	Houston	Texas
United States	Florida Cancer Specialists	Lake Mary	Florida
United States	University of Southern California	Los Angeles	California
United States	The Sarah Cannon Research Institute	Nashville	Tennessee
United States	Yale Cancer Center	New Haven	Connecticut
United States	New York University (NYU) Clinical Cancer Center	New York	New York
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania
United States	Providence Portland Medical Center	Portland	Oregon
United States	Washington University - St. Louis	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
CytomX Therapeutics

Countries where clinical trial is conducted

United States,  Korea, Republic of,  Spain,  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 CX-2029 as a monotherapy		21 days (dose-limiting toxicity period)
Secondary	The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-2029 as a monotherapy		2 years