Actively Recruiting
Antibody CC-1 in Men With Biochemical Recurrence of Prostate Cancer
Led by University Hospital Tuebingen · Updated on 2024-05-16
56
Participants Needed
1
Research Sites
211 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a phase I open-label, single center study designed to evaluate the safety, tolerability and preliminary efficacy of the bispecific prostate specific membrane antigen (PSMA) and cluster of differentiation protein 3 (CD3) antibody CC-1 in men with biochemical recurrence (BCR) of prostate cancer (PC). The PSMA binder in CC-1 reacts with tumor cells and also binds to tumor vessels, thereby allowing for a dual mode of anti-cancer action. CC-1 was developed in a novel format, which not only prolongs serum half-life, but most importantly reduces off-target T-cell activation with accordingly reduced side effects. The study entails a part I (dose escalation part) to identify the maximally tolerated dose of CC-1, which then will be further evaluated in part II of the study (dose expansion part). After application of two low doses as safety steps in the first cycle, CC-1 will be applied twice weekly for three consecutive weeks within 4 week cycles as a short-term intravenous infusion (3 hours). The planned trial ultimately shall define the recommended phase II dose (RP2D) of CC-1 in the disease setting of BCR of PC.
CONDITIONS
Official Title
Antibody CC-1 in Men With Biochemical Recurrence of Prostate Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Able to understand and comply with the study protocol including treatment and visits
- Male aged 18 years or older
- Previous histologic diagnosis of prostatic adenocarcinoma
- Low risk of rapid disease progression defined by PSA-detection time and ISUP grade criteria depending on prior treatment
- Biochemical recurrence after last definitive treatment with PSA ≥0.2 ng/mL or PSA > nadir + 2 ng/mL (after radiation therapy) and two rising PSA values
- No distant metastasis confirmed by PSMA-PET imaging
- ECOG performance status of 0 or 1
- Agree to use effective contraception if sexually active with partners of child-bearing potential
- Adequate bone marrow, kidney, and liver function based on recent lab tests
You will not qualify if you...
- PSA greater than 5 ng/mL
- For prior radical prostatectomy patients: PSA doubling time less than 1 year or pathological ISUP grade 4-5
- For prior radiation therapy patients: interval to biochemical recurrence less than 18 months or biopsy ISUP grade 4-5
- Other malignancy within the last 2 years except treated non-melanoma skin cancer or low-grade bladder cancer
- Current or recent participation in another interventional anticancer trial within 30 days
- Receiving or received androgen deprivation therapy except limited neoadjuvant/adjuvant use as specified
- Castrate serum testosterone level below 50 ng/dL at screening
- History of HIV infection
- Active or chronic hepatitis B or C infection
- Active autoimmune disease
- Significant central nervous system disorders
- Taking therapeutic anticoagulation
- Uncontrolled hypertension
- Heart failure classified as NYHA III or IV
- Severe lung function disorders
- Known intolerance or hypersensitivity to CC-1 or related drug products
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Tuebingen
Tübingen, Germany, 72076
Actively Recruiting
Research Team
W
Walz
CONTACT
J
Jonas Heitmann, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
2
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