Description:
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
Title
- Brief Title: PROCLAIM-CX-188: A Trial to Find Safe and Active Doses of an Investigational Drug CX-188 for Patients With Solid Tumors
- 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 IDs
- ORG STUDY ID:
CTMX-M-188-001
- NCT ID:
NCT03706274
Conditions
Interventions
Drug | Synonyms | Arms |
---|
CX-188 | | CX-188 Alternative Dosing Schedule |
Purpose
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
Trial Arms
Name | Type | Description | Interventions |
---|
CX-188 Escalation | Experimental | | |
CX-188 Alternative Dosing Schedule | Experimental | | |
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
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | The number of subjects experiencing a dose-limiting toxicity at various dose levels when given CX-188 as a monotherapy |
Time Frame: | 21 days |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-188 as monotherapy |
Time Frame: | 2 years |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Withdrawn |
Lead Sponsor: | CytomX Therapeutics |
Last Updated
May 5, 2021