Actively Recruiting
A Study to Test a New Immunotherapy, ABX-001, Alone and in Combination With the Marketed Drug, Pembrolizumab, for the Treatment of Tumors Previously Treated With Other Therapies
Led by Abalos Therapeutics GmbH · Updated on 2026-01-16
27
Participants Needed
5
Research Sites
54 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase I/Ib first-in-human, open-label, non-randomized, multicenter, multi-country study to evaluate the safety and tolerability and to establish a recommended Phase 2 dose (RP2D) as well as assess preliminary clinical activity of ABX-001 administered intravenously (IV) alone (Part A) or co-administered with pembrolizumab (Part B) in participants with refractory/relapsed advanced solid tumors.
CONDITIONS
Official Title
A Study to Test a New Immunotherapy, ABX-001, Alone and in Combination With the Marketed Drug, Pembrolizumab, for the Treatment of Tumors Previously Treated With Other Therapies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to give consent and at least 18 years old at informed consent signing
- Diagnosis of advanced or recurrent solid tumors
- Part A: Disease progressed despite or intolerant to standard therapy, or no standard therapy available
- Part B: Histologically confirmed locally advanced or metastatic disease with prior pembrolizumab treatment and resistance
- Tumor lesion suitable for biopsy and a separate lesion for response monitoring
- Measurable disease according to RECIST 1.1 criteria
- Eastern Cooperative Oncology Group performance status 0 or 1
- Life expectancy of at least 12 weeks
- Adequate organ function including blood counts, liver, kidney, thyroid, and heart function
- Female participants must not be pregnant or breastfeeding and use effective contraception if of childbearing potential
- Male participants must agree to use contraception
- Willing and able to comply with all study assessments and requirements
- Able to comprehend and willing to sign informed consent
You will not qualify if you...
- Malignancy other than the study disease unless disease-free for over 2 years and not affecting safety
- Symptomatic or recently steroid-treated CNS metastases
- Carcinomatous meningitis or leptomeningeal spread
- Active autoimmune disease requiring systemic treatment in past 2 years
- Medical condition needing systemic immunosuppressive treatment within 28 days before treatment
- Unstable liver or biliary disease
- History of vasculitis
- Active bleeding or severe coagulation issues within 6 months
- Known HIV infection or active hepatitis B or C
- Any active infection
- Prolonged QT interval on ECG
- Recent history of serious gastrointestinal conditions
- Recent allergen desensitization therapy
- Significant cardiovascular risk or recent cardiac events
- History of certain lung diseases or pneumonitis
- Uncontrolled ascites or pleural effusions recently
- Serious or unstable medical or psychiatric conditions affecting safety or compliance
- Immediate family member involved in the study staff without approval
- Recent treatment with checkpoint inhibitors, anticancer or investigational therapies within 28 days
- Recent radiation therapy without adequate washout period
- Receipt of live vaccine within 30 days
- Prior bone marrow or solid organ transplant
- Significant unresolved toxicity from prior treatments
- Recent blood transfusion or colony stimulating factors use
- Major surgery within 28 days before treatment
- Known drug or alcohol abuse
- Hypersensitivity to study drugs or components
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Charite-Universitaetsmedizin Berlin - Campus Benjamin Franklin (CBF)
Berlin, Germany, 12200
Actively Recruiting
2
Universitaetsklinikum Tuebingen
Tübingen, Germany, 72076
Actively Recruiting
3
Vall d'Hebron Institut d'Oncologia
Barcelona, Spain, 08035
Actively Recruiting
4
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain, 28040
Actively Recruiting
5
The START Center for Cancer Care - CIOCC
Madrid, Spain, 28050
Actively Recruiting
Research Team
T
Thomas Bogenrieder, Chief Medical Officer, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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