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New treatment option for Colorectal Cancer
Official title FIH, Bispecific CD276xCD3 Antibody CC-3 in Patients With Colorectal Cancer
ClinicalTrials.gov ID: NCT05999396
What this study is testing
What is Administration of CC-3?
Administration of CC-3 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for colorectal cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- written signed informed consent
- Patient is able to understand and comply with the protocol for the duration of the clinical trial including undergoing treatment and scheduled visits...
- Patients with progressing metastatic CRC who were previously treated with FOLFOX, FOLFIRI, FOLFOXIRI, TAS-102, or regorafenib, if applicable in...
- At least one measurable lesion that can be accurately assessed at baseline by CT or MRI and is suitable for repeated assessment per RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
You likely can't join if
- Other malignancy requiring treatment within the last year except: adequately treated non-melanoma skin cancer and low-grade non-muscle invasive...
- Concurrent or previous treatment within 30 days in another treatment clinical trial with an investigational anticancer therapy
- Persistent toxicity (≥ Grade 2 according to Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) caused by previous cancer therapy...
- Clinical signs of active infection (\> grade 2 according to CTCAE version 5.0)
- Known cerebral/meningeal manifestation of CRC
- History of HIV infection
See the full eligibility criteria
- written signed informed consent
- Patient is able to understand and comply with the protocol for the duration of the clinical trial including undergoing treatment and scheduled visits and examinations
- Patients with progressing metastatic CRC who were previously treated with FOLFOX, FOLFIRI, FOLFOXIRI, TAS-102, or regorafenib, if applicable in combination with anti-VEGFR monoclonal antibody (mAb) and anti-EGFR mAb...
- At least one measurable lesion that can be accurately assessed at baseline by CT or MRI and is suitable for repeated assessment per RECIST 1.1.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2
- Patient aged ≥ 18, no upper limit
- Female patients of child bearing potential (FCBP) and male patients with partners of child bearing potential, who are sexually active, must agree to the use of two effective forms (at least one highly effective method)...
- For FCBP two negative pregnancy test (sensitivity of at least 25 mU/ml) prior to first application of CC-3
- All people must agree to refrain from donating blood while on study drug and for 2 months after last dose of CC-3.
- Adequate bone marrow, renal, and hepatic function defined by laboratory tests within 14 days prior to study treatment:
- Hemoglobin ≥ 9 g/dl (Transfusion of packed red blood cells prior to enrolment allowed)
- Neutrophil count ≥ 1,500/mm3
- Platelet count ≥ 75,000/µl
- Serum creatinine ≤ 1.5mg/dl or creatinine clearance ≥ 60ml/min
- hepatic function of patients without current hepatic metastasis:
- Bilirubin ≤ 1.5x upper limit of normal (ULN), in case of known Gilbert syndrome higher values are allowed if due to increase of indirect bilirubin
- ALT and AST ≤ 2.5 x ULN
- hepatic function of patients with current hepatic metastasis:
- Bilirubin ≤ 2.5 x upper limit of normal (ULN)
- ALT and AST ≤ 5. x ULN
- Other malignancy requiring treatment within the last year except: adequately treated non-melanoma skin cancer and low-grade non-muscle invasive papillary bladder cancer.
- Concurrent or previous treatment within 30 days in another treatment clinical trial with an investigational anticancer therapy
- Persistent toxicity (≥ Grade 2 according to Common Terminology Criteria for Adverse Events [CTCAE] version 5.0) caused by previous cancer therapy, excluding alopecia and neurotoxicity
- Clinical signs of active infection (\> grade 2 according to CTCAE version 5.0)
- Known cerebral/meningeal manifestation of CRC
- History of HIV infection
- Viral active or chronic hepatitis (HBV or HCV)
- Ongoing autoimmune disease
- History of relevant CNS pathology or current relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic...
- Therapeutic anticoagulation therapy
- Major surgery within 4 weeks of starting study treatment. Patients must have recovered from any effects of major surgery.
- Patients receiving any systemic chemotherapy, mAb or radiotherapy within 2 (for mAb 4) weeks prior to study treatment or a longer period depending on the defined characteristics of the agents used
- Heart failure NYHA III/IV
- Severe obstructive or restrictive ventilation disorder
- Known intolerance to CC-3 or other immunoglobulin drug products as well as hypersensitivity to any of the excipients present in CC-3
- Live and live-attenuated vaccination 30 days prior to treatment
- Pregnant or breast-feeding women
- Current ileus with severely altered GI function
The study team makes the final eligibility decision.
Where it's taking place
- Tübingen, Baden-Wurttemberg, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tübingen, Baden-Wurttemberg, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.