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

Phase 1

Withdrawn

• Conditions: Solid Tumor, Adult
• Interventions: Drug: CX-188

• Registration Number: NCT03706274
• Lead Sponsor: CytomX Therapeutics

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-11
• Study First Posted: 2018-10-15
• Study Start: 2020-01
• Primary Completion: 2020-12
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-05
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CX-188 Escalation	CX-188	-
CX-188 Alternative Dosing Schedule	CX-188	-

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

Virginia Cancer Specialists; 🇺🇸 Fairfax, Virginia, United States