PROCLAIM-CX-188: A Trial to Find Safe and Active Doses of an Investigational Drug CX-188 for Patients With Solid Tumors

Solid Tumor, Adult Clinical Trial

Official title:

A Phase 1, Open-Label, Dose-Ranging Study of the PD-1 Probody Therapeutic CX-188 in Adults With Recurrent or Metastatic Solid Tumors

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03706274
• Other study ID #: CTMX-M-188-001
• Status: Withdrawn
• Phase: Phase 1
• Start date: January 2020
• Est. completion date: December 2022

Study information

• Verified date: April 2021
• 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-188 is to characterize the safety, tolerability, pharmacokinetics (PK), and antitumor activity of CX-188 in adult subjects with metastatic or advanced unresectable solid tumors that progressed on standard therapy: PROCLAIM: PRObody Clinical Assessment in Man CX-188 clinical trial 001

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

2. agreement to provide mandatory archival tumor or fresh biopsy before they can be considered for inclusion in the study 3. At least 18 years old

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. 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

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

• Neoplasms
• Solid Tumor, Adult

Intervention

Drug:
• CX-188
CX-188

Locations

Country	Name	City	State
United States	Virginia Cancer Specialists	Fairfax	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
CytomX Therapeutics

Country where clinical trial is conducted

United States, 

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-188 as a monotherapy		21 days
Secondary	The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-188 as monotherapy		2 years