Actively Recruiting
ABL103 in Combination With Pembrolizumab, With or Without Taxane in Advanced or Metastatic Solid Tumors
Led by ABL Bio, Inc. · Updated on 2025-09-08
65
Participants Needed
6
Research Sites
121 weeks
Total Duration
On this page
Sponsors
A
ABL Bio, Inc.
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is to assess the safety and antitumor activity of ABL103 plus pembrolizumab, with or without taxane, in advanced or metastatic solid tumors.
CONDITIONS
Official Title
ABL103 in Combination With Pembrolizumab, With or Without Taxane in Advanced or Metastatic Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must understand and be willing to provide informed consent and comply with study procedures and restrictions
- Must be 18 years of age or older on the day of signing the informed consent form
- Must have histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor
- Must have relapsed, be refractory to, or be intolerant of available standard therapy
- Must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 7 days before first study drug administration
- Must have recovered from adverse events from prior therapy to Grade 1 or baseline more than 14 days before first study drug administration, except alopecia or stable/irreversible Grade 2 toxicities
- Must have adequate hematologic, renal, hepatic, and thyroid function at screening and within 7 days prior to first study drug administration
- Female subjects who are not surgically sterile or postmenopausal must agree to use highly effective birth control (preferably 2 methods) during the study and for 6 months after last dose
- Female subjects of childbearing potential must have a negative pregnancy test at screening and within 7 days prior to Cycle 1 Day 1
- Male subjects with female partners of childbearing potential must agree to contraception and not donate sperm during treatment and for at least 6 months after final dose
- Male subjects with pregnant or breastfeeding partners must agree to abstain or use condoms during study and for at least 6 months after final dose, with partner using additional contraception
You will not qualify if you...
- Prior anticancer monoclonal antibody treatment or investigational therapy with unresolved pharmacologic or toxicity effects before first study drug administration
- Radiotherapy within 2 weeks before first study drug administration or radiation-related toxicities requiring corticosteroids
- Prior immunotherapy discontinued due to Grade 3 or higher immune-related adverse events (irAEs), except treatable endocrine disorders, or due to Grade 2 myocarditis or recurrent Grade 2 pneumonitis
- Radiation therapy to the lung exceeding 30 Gy within 6 months before first dose
- Risk factors for bowel obstruction or perforation, such as history of acute diverticulitis, intra-abdominal abscess, or abdominal carcinomatosis (except ovarian cancer with abdominal carcinomatosis history is allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
UH Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Not Yet Recruiting
2
PASO Medical
Frankston, Victoria, Australia, 3199
Not Yet Recruiting
3
Seoul National University Bundang Hospital
Seongnam, South Korea, 13620
Actively Recruiting
4
Seoul National University Hospital
Seoul, South Korea, 03080
Actively Recruiting
5
Asan Medical Center
Seoul, South Korea, 05505
Not Yet Recruiting
6
Samsung Medical Center
Seoul, South Korea, 06351
Not Yet Recruiting
Research Team
D
Dayoung Ok
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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