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

NCT03706274 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: CTMX-M-188-001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The number of subjects experiencing a dose-limiting toxicity at various dose levels when given CX-188 as a monotherapy

  21 days

Secondary Outcomes (1)

• The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-188 as monotherapy

  2 years

Study Arms (2)

CX-188 Escalation

EXPERIMENTAL

Drug: CX-188

CX-188 Alternative Dosing Schedule

EXPERIMENTAL

Drug: CX-188

Interventions

CX-188 DRUG

CX-188

CX-188 Alternative Dosing Schedule; CX-188 Escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Prior therapy with a chimeric antigen receptor (CAR) T-cell containing regimen.
• History of severe allergic or anaphylactic reactions to human monoclonal antibody therapy or known hypersensitivity to any Probody therapeutic
• Human immunodeficiency virus (HIV) or acquired immune deficiency syndrome (AIDS)-related illness, chronic hepatitis B or C
• History of or current active autoimmune diseases
• History of syndrome or medical condition(s) that requires systemic steroids (\> 10 mg daily prednisone equivalents) or immunosuppressive medications
• History of allogeneic tissue/solid organ transplant, prior stem cell or bone marrow transplant
• Chemotherapy, biochemotherapy, radiation or immunotherapy or any investigational treatment within 30 days prior to receiving any study drug
• 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

Sponsors & Collaborators

• CytomX Therapeutics: lead

Study Sites (1)

Virginia Cancer Specialists

Fairfax, Virginia, 22031, United States

Location

Study Officials

• Yifah Yaron, MD

  CytomX Therapeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: October 15, 2018
• Study Start: January 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2022
• Last Updated: May 5, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)