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

NCT ID: NCT03706274

Last Updated: 2021-05-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-31
• Study Completion Date: 2022-12-31

Brief 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

Conditions

Solid Tumor, Adult

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CX-188 Escalation

Group Type: EXPERIMENTAL

CX-188

Intervention Type: DRUG

CX-188

CX-188 Alternative Dosing Schedule

Group Type: EXPERIMENTAL

CX-188

Intervention Type: DRUG

CX-188

Interventions

CX-188

CX-188

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CytomX Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yifah Yaron, MD

Role: STUDY_DIRECTOR

CytomX Therapeutics

Locations

Virginia Cancer Specialists

Fairfax, Virginia, United States

Countries

United States

Other Identifiers

CTMX-M-188-001

Identifier Type: -

Identifier Source: org_study_id