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

Sponsor

CytomX Therapeutics (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT03706274

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Solid Tumor, Adult	Drug: CX-188	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2020

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CX-188 Escalation	Drug: CX-188 CX-188
Experimental: CX-188 Alternative Dosing Schedule	Drug: CX-188 CX-188

Arm

Intervention/Treatment

Experimental: CX-188 Escalation

Drug: CX-188

CX-188

Experimental: CX-188 Alternative Dosing Schedule

Drug: CX-188

CX-188

Outcome Measures

Primary Outcome Measures

The number of subjects experiencing a dose-limiting toxicity at various dose levels when given CX-188 as a monotherapy [21 days]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Virginia Cancer Specialists	Fairfax	Virginia	United States	22031

Sponsors and Collaborators

CytomX Therapeutics

Investigators

Study Director: Yifah Yaron, MD, CytomX Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CytomX Therapeutics

ClinicalTrials.gov Identifier:

NCT03706274

Other Study ID Numbers:

CTMX-M-188-001

First Posted:

Oct 15, 2018

Last Update Posted:

May 5, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Study Results

No Results Posted as of May 5, 2021