NCT03706274WithdrawnPhase 1
A Phase 1, Open-Label, Dose-Ranging Study of the PD-1 Probody Therapeutic CX-188 in Adults With Recurrent or Metastatic Solid Tumors
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Withdrawn
- Sponsor
- CytomX Therapeutics
- Locations
- 1
- Primary Endpoint
- The number of subjects experiencing a dose-limiting toxicity at various dose levels when given CX-188 as a monotherapy
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
CX-188 Escalation
Experimental
Intervention: CX-188 (Drug)
CX-188 Alternative Dosing Schedule
Experimental
Intervention: CX-188 (Drug)
Outcomes
Primary Outcomes
The number of subjects experiencing a dose-limiting toxicity at various dose levels when given CX-188 as a monotherapy
Time Frame: 21 days
Secondary Outcomes
- The percentage of subjects experiencing anti-cancer activity (ORR) at various dose levels when given CX-188 as monotherapy(2 years)
Investigators
Study Sites (1)
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