NL-OMON48575
Completed
Phase 2
A Phase 1-2, Open-Label, Dose-Finding, Proof of Concept, First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CX-2009 in Adults with Metastatic or Locally Advanced Unresectable Solid Tumors - PROCLAIM-CX-2009
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CytomX Therapeutics, Inc.
- Enrollment
- 22
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial ended prematurely
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects who fulfill the following criteria at Screening will be eligible for
- •admission into the
- •1\. Histologically confirmed diagnosis of active metastatic or locally advanced
- •unresectable
- •solid tumor in subjects who have disease progression after treatment with
- •available therapies
- •that are known to confer clinical benefit, or who are intolerant to treatment,
- •in the following
- •indications (with guidance for standard treatment below).
- •For Parts A2, B, C1, C2, D1, and D2, an archival tumor tissue sample must be
Exclusion Criteria
- •Subjects who fulfill any of the following criteria at Screening will not be
- •eligible for admission:
- •1\. Neuropathy \>Grade 1;
- •2\. Active or chronic corneal disorder, including but not limited to the
- •following: Sjogren's syndrome, Fuchs corneal dystrophy (requiring treatment),
- •history of corneal transplantation, active herpetic keratitis, and also active
- •ocular conditions requiring ongoing treatment/monitoring such as wet
- •age\-related macular degeneration requiring intravitreal injections, active
- •diabetic retinopathy with macular edema, presence of papilledema, and acquired
- •monocular vision;
Outcomes
Primary Outcomes
Not specified
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