Actively Recruiting
FIH, Bispecific CD276xCD3 Antibody CC-3 in Patients With Colorectal Cancer
Led by German Cancer Research Center · Updated on 2025-05-21
89
Participants Needed
1
Research Sites
167 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a first in human (FIH) clinical trial in patients with Colorectal cancer (CRC) after failure of at least three lines of previous therapy aiming to evaluate safety and efficacy of CC-3, a bispecific antibody (bsAb) with CD276xCD3 specificity developed within DKTK. CC-3 binds to CD276 on cancer cells as well as to tumor vessels of CRC, thereby allowing for a dual mode of anti-cancer action. CC-3 was developed in a novel format which not only prolongs serum half-life, but most importantly reduces off-target T cell activation with expected fewer side effects. A similar construct in this format with PSMAxCD3 specificity is presently undergoing clinical evaluation in patients with prostate cancer (NCT04104607), with very favorable safety and preliminary efficacy. The optimized format that CC-3 shares with its PSMAxCD3 "sister molecule" allows for application of effective bsAb doses with expected high anticancer activity. The clinical trial comprises two phases: The first phase is a dose-escalation part to evaluate the maximally tolerated dose (MTD) of CC-3. This is followed by a dose-expansion part to defined the recommended phase II dose. A translational research program comprising, among others, analysis of CC-3 half-life and the induced immune response will serve to better define the mode of action of CC-3.
CONDITIONS
Official Title
FIH, Bispecific CD276xCD3 Antibody CC-3 in Patients With Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written signed informed consent
- Ability to understand and comply with the clinical trial protocol
- Patients with progressing metastatic colorectal cancer previously treated with FOLFOX, FOLFIRI, FOLFOXIRI, TAS-102, or regorafenib, with anti-VEGFR and anti-EGFR antibodies if applicable
- Patients with MSI-high/dMMR tumors must have received checkpoint inhibitor therapy and at least two additional lines of therapy
- BRAF V600E mutation patients must have received cetuximab with encorafenib in second- or third-line treatment
- At least one measurable tumor lesion suitable for repeated assessment by CT or MRI
- ECOG performance status of 2 or less
- Age 18 years or older with no upper age limit
- Women of childbearing potential and sexually active men with partners of childbearing potential must use two effective contraception methods during and 2 months after treatment
- For women of childbearing potential, two negative pregnancy tests prior to first dose
- Agreement to refrain from blood donation during treatment and 2 months after last dose
- Adequate bone marrow, kidney, and liver function based on laboratory tests within 14 days before treatment
You will not qualify if you...
- Other malignancies requiring treatment within the past year except treated non-melanoma skin cancer or low-grade non-muscle invasive bladder cancer
- Participation in another interventional clinical trial with investigational anticancer therapy within 30 days
- Persistent toxicity grade 2 or higher from previous cancer therapy (except alopecia and neurotoxicity)
- Active infection grade 3 or higher
- Known brain or meningeal involvement of colorectal cancer
- History of HIV infection
- Active or chronic hepatitis B or C infection
- Ongoing autoimmune disease
- Relevant current or past central nervous system conditions such as seizures, stroke, severe brain injury, dementia, or psychosis
- Use of therapeutic anticoagulation
- Major surgery within 4 weeks prior to starting treatment
- Systemic chemotherapy, monoclonal antibody, or radiotherapy within 2 weeks (4 weeks for monoclonal antibodies) prior to treatment
- Heart failure NYHA class III or IV
- Severe obstructive or restrictive lung disease
- Known intolerance or hypersensitivity to CC-3 or its components
- Live or live-attenuated vaccines within 30 days prior to treatment
- Pregnant or breastfeeding women
- Current bowel obstruction with severe gastrointestinal dysfunction
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Hospital Tuebingen
Tübingen, Baden-Wurttemberg, Germany, 72076
Actively Recruiting
Research Team
J
Juliane Walz, Prof. Dr.
CONTACT
J
Jonas Heitmann, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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