Actively Recruiting
This is a Study to Evaluate the Safety and Tolerability of ABL503, and to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ABL503 in Subjects with Any Progressive Locally Advanced or Metastatic Solid Tumors
Led by ABL Bio, Inc. · Updated on 2025-02-06
100
Participants Needed
8
Research Sites
271 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a first-in-human Phase 1, single-arm, open-label, multicenter, multiple-dose, dose-escalation and dose-expansion study of ABL503 to evaluate the safety, tolerability, MTD and/or RP2D, PK, immunogenicity, preliminary antitumor activity, and the PD effect of ABL503 in subjects with any progressive locally advanced (unresectable) or metastatic solid tumors who are relapsed or refractory following the last line of treatment and have no available standard of care option. This study includes 3 parts: a dose-escalation part, a dose-expansion part and tumor-expansion part
CONDITIONS
Official Title
This is a Study to Evaluate the Safety and Tolerability of ABL503, and to Determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of ABL503 in Subjects with Any Progressive Locally Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed progressive locally advanced (unresectable) or metastatic solid tumors relapsed or refractory after last treatment, with no effective standard therapy or standard therapy not appropriate
- Stable or improved Grade 2 toxicities (excluding alopecia) from prior therapy to Grade 1 or baseline more than 14 days before first study drug dose
- Adequate blood, liver, and kidney function confirmed by screening labs and repeated within 72 hours before first ABL503 dose
You will not qualify if you...
- Prior anticancer monoclonal antibody or investigational therapy within 28 days before first study drug dose or unresolved adverse events from previous treatment above Grade 1
- Chemotherapy or radiation therapy within 2 weeks or targeted small molecule therapy within 5 half-lives before first study drug dose or unresolved adverse events above Grade 1
- Required or received systemic steroids or other immunosuppressive therapy within 14 days before study drug administration
- Risk factors for bowel obstruction or perforation, such as history of acute diverticulitis, intra-abdominal abscess, or abdominal carcinomatosis
- Discontinued prior immunomodulatory therapy due to intolerable immune-related adverse events needing systemic steroids
- History or current pneumonitis or interstitial lung disease
- Previous treatment with anti-4-1BB antibody
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
City of Hope
Duarte, California, United States, 91010
Actively Recruiting
2
USC
Los Angeles, California, United States, 90033
Actively Recruiting
3
UCLA
Santa Monica, California, United States, 90404
Actively Recruiting
4
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, United States, 80218
Actively Recruiting
5
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
6
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
7
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
8
Asan Medical Center
Seoul, South Korea, 05505
Actively Recruiting
Research Team
J
Juyeun Jeon
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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