A Phase 1 interventional study of Administration of CC-3 in Colorectal Cancer, Breast Carcinoma and Sarcoma, sponsored by German Cancer Research Center. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by German Cancer Research Center · Phase 1, Interventional, and Treatment
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.
Metastasized CRC is an aggressive malignant disease with poor prognosis after failure of at least three lines of previous therapy, with an accordingly high medical need for new therapeutic approaches. Except for the small population with microsatellite instability, so far no relevant progress has been achieved in CRC by immunotherapeutics. CC-3 is designed to direct T cells towards CRC tumor cells and additionally reacts with tumor vessels. If successful, the trial establishes a novel type of dual anti-cancer action by also attacking tumor blood supply and allowing for improved influx of immune effector cells and thus holds promise as a new concept of immunotherapy for cancer patients.
The rationale for the therapeutic use of CC-3 is based on its proposed mode of action as a bsAb being specifically designed to direct T cells via its CD3 binding part towards tumor target cells via its CD276 binding part. Furthermore, CC-3 also reacts with tumor vessels of CRC thereby allowing for a dual mode of anti-cancer action by also attacking tumor blood supply and allowing for improved influx of immune effector cells. Due to its unique ability to redirect T cells via CD3 for CD276 expressing tumor cell lysis, CC-3 can elicit repeated target cell elimination by cytotoxic T cells and a polyclonal response of previously primed CD4+ and CD8+ T cells. Compared to other immunotherapeutics presently being approved or in development (bsAbs with alternative formats like the authorised bsAb blinatumomab or other antibodies or CAR T cells), CC-3 is expected to offer the following major advantages:
(i) reduction of side effects due to its optimal bsAb format and choice of TAA, which will allow for application of truly effective bsAb doses and accordingly increased efficacy; (ii) CD276 enables dual targeting, thereby improving accessibility of CRC tumors to immune effector cells, as prerequisite for therapeutic success (iii) CC-3 is an "off the shelf drug" eliminating the preparative work required for CART cell generation that delays treatment; (iv) the introduction of the YTE modification will allow for prolonged half-life an thus convenient dosing scheme
Clinical trial rationale with regard to objectives and further development of CC-3
In nonclinical studies, in vitro and in vivo, proof of concept, preliminary pharmakokinetic (PK) and pharmakodynamic (PD) effects as well as toxicology have been evaluated as described in detail in the IB . However, due to differences between animal models and the human situation, some aspects have to be assessed and further characterised in humans. For example, the target mediated drug disposition (TMDD), an effect that largely influences the serum half-life of antibody molecules particularly at low concentrations, cannot be properly addressed in mice. Similar problems arise with the YTE modification, which prolongs serum half-life of antibodies in humans but not in mice.Furthermore, non-human primates (NHP) and rodents have several limitations as predictive models for toxicity and immunogenicity evaluation of CC-3. The CD3 binding part of CC-3 does not cross-react with CD3 of macaques and thus it is not possible to evaluate in these NHPs dose limiting side effects. Therefore, a First in Human clinical trial is planned for CC-3 to characterise the effects of CC-3 in humans. In general CD276 is a target antigen with particularly attractive properties. It is expressed not only on tumor cells but also on tumor vessels, allowing for "dual targeting" of a variety of solid tumors including (but not limited to) GI cancer. The importance of vascular targeting for treatment of solid tumors has been elegantly demonstrated in numerous reports.
As described in detail in the IB, CD276 is expressed on all analysed samples (n=59) of colorectal tumor samples of patients with metastazised disease. Of note, CD276 is expressed on the primary tumor as well as on metastasis. Therefore, the analysis of CD276 expression on the tumor comprises an exploratory objective of this trial but is not needed for inclusion of patients.
The phase I trial is designed to confirm and further explore the safety and tolerability of the CD276xCD3 bsAb CC-3 in adult patients with CRC after failure of at least three lines of previous therapy. The primary objectives are to define the MTD and RP2D of CC-3 and the overall safety defined as incidence and severity of AEs under therapy with CC-3. Furthermore, the trial aims to expand experience on pharmacokinetics, pharmacodynamics and toxicology of CC-3 from nonclinical- studies. A focus will be on the following specific aspects/parameters:
Dose rationale for CC-3
Considerations on a safe starting dose of 20µg for CC-3 are, besides preclinical in vitro and in vivo data of CC-3, based on the meanwhile available PK data from a clinical study with CC-1, an identically formatted bsAb with PSMAxCD3 - (rather than CD276xCD3)-specificity, but also on clinical experience with MGD009, a bsAb with CD276xCD3-specificity as well as recently published data from several clinical studies with CD20xCD3 bsAb. The target dose of 4mg CC-3 is based on observations from the in vivo model with humanized NSG mice, where repetitive dosing with 1.4µg CC-3 was able to eradicate established flank tumors. This dose corresponds to approximately 4mg once per week in humans. Further details can be found in the IB of CC-3.
Safety and expected risks of the IMP
For CC-3, so far, no clinical safety data from other clinical trials are available. CC-3 has been preclinically characterized extensively in vitro and in vivo, the toxicity of the treatment class of bsAbs, with CRS as main class toxicity, is well known and safety data for CC-1, an identically formatted bsAb with PSMAxCD3 (rather than CD276xCD3)-specificity, which was extensively investigated in the ongoing clinical FIH study is available.
In this FIH trial (NCT04104607, DKTK_PMO_1605), investigating CC-1 in patients with CRPC, CRS was the most frequently observed toxicity, experienced by 78% of the patients. Notably, it never exceeded grade 2 after pre-emptive tocilizumab application and resolved in most cases without additional application of tocilizumab. Besides mild to moderate hypertension (observed in 50% of patients), no further CC-1 related toxicities (i.e., anaphylactic reaction) were observed. As expected and attributable to tocilizumab application, hematologic events (i.e. neutropenia, thrombocytopenia) were present in most patients, and hepatotoxicity was observed in some patients.
As CC-3 is shares the biological function with CC-1 and other bsAb, a similar or even better safety profile is expected. Especially in comparison to CC-1, with CC-3 a lower risk for CRS is expected as the CD3 binder has been attenuated. In addition, nowdays CRS is a well-known class toxicity of bsAb and risk mitigation strategies by e.g. application of tocilizumab are available. The selected dosing scheme of CC-3 in this clinical trial will not only allow for continous exposure of tumor cells to CC-3, but it is also considered to increase the tolerability of CC-3 by introduction of priming doses. Moreover, CC-3 is applied during daytime when dedicated experienced study personnel is present and can ensure close monitoring of patients during and after CC-3 application.
6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.
This study's planned enrollment of 89 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →German Cancer Research Center is the lead sponsor of 49 studies on the registry; 13 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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In case of MSI-high/dMMR tumors, patients should have received therapy and at least two further of that stated above.
In case of patients BRAF V600E mutation patients should have received: Cetuximab in combination with encorafenib in second- or third-line treatment.
Adequate bone marrow, renal, and hepatic function defined by laboratory tests within 14 days prior to study treatment:
hepatic function of patients without current hepatic metastasis:
hepatic function of patients with current hepatic metastasis:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The DL in the accelerated titration phase is fixed in each patient and is applied once per week. The start dose for the first patient is 20µg. Dose increase in the next patient is determined by SRC, comprised of investigators and Sponsor, and can be up to 100% based on safety, PK and PD data. Accelerated titration is terminated and switched to a standard 3 + 3 design in case of any AE Grade ≥ 2 (except AEs unequivocally due to underlying disease or an extraneous cause), occurrence of DLT or decision of SRC based on PK, PD, and safety data. In the dose expansion part, additional patients are treated to have 20 evaluabale patients at the MTD level defined in the dose escalation part.
Drug: Administration of CC-3
Accelerated titration phase, Standard 3+3 titration phase, expansion phase
Safety 1-Adverse Events Assessment
Dose escalation and dose expansion part: Characterization of the safety of CC-3 in patients with metastasized CRC, and to define the recommended phase-II dose (RP2D) of CC-3 Adverse events should be documented and recorded continuously. Patients have to be followed for AEs from visit T1V1( treatment week1 Visit 1) up to last clinical trial visit or until all drug-related toxicities have been resolved, whichever is later, or until the investigator assesses AEs as "chronic" or "stable". Each occurrence of an AE must be reported once indicating the CTC (Version 5.0) grade. If the CTC grading of an ongoing AE changes this has to be reported. If an event stops and later restarts, all occurrences must be reported. AEs will be coded using the Medical Dictionary for Regulatory Activities (MedDRA®) v26.0 or higher. All AEs will be graded according to the CTCAEv5.0, except for cytokine release syndrome, which will be graded according to modified criteria by Lee et al. (Lee et al., 2019).
Time frame: Day 1 Day 2 Day 3 Day 8 +/- 1 day Day 9 Day 15 +/- 1 day Every 7 days +/- 2 days after Treatment week 3 7 days +/- 2 days after last CC-3 28 days +/- 2 days after last CC-3 28 days after FU +/- 3 days
Safety 2 -Blood Chemistry-Transaminases
AST/SGOT in \[U/l\] ALT/SGPT in \[U/l)
Time frame: Day 1 Day 2 Day 3 Day 8 +/- 1 day Day 9 Day 15 +/- 1 day Every 7 days +/- 2 days after Treatment week 3 7 days +/- 2 days after last CC-3 28 days +/- 2 days after last CC-3 28 days after FU +/- 3 days
Safety 3-Hematology-haemoglobin
haemoglobin in \[g/l\]
Time frame: Day 1 Day 2 Day 3 Day 8 +/- 1 day Day 9 Day 15 +/- 1 day Every 7 days +/- 2 days after Treatment week 3 7 days +/- 2 days after last CC-3 28 days +/- 2 days after last CC-3 28 days after FU +/- 3 days
Safety 3-Hematology-Red Blood Cells
RBC in \[cells/µl\]
Time frame: Day 1 Day 2 Day 3 Day 8 +/- 1 day Day 9 Day 15 +/- 1 day Every 7 days +/- 2 days after Treatment week 3 7 days +/- 2 days after last CC-3 28 days +/- 2 days after last CC-3 28 days after FU +/- 3 days
Safety 3-Hematology-thrombocytes
PLT in \[cells/µl\]
Time frame: Day 1 Day 2 Day 3 Day 8 +/- 1 day Day 9 Day 15 +/- 1 day Every 7 days +/- 2 days after Treatment week 3 7 days +/- 2 days after last CC-3 28 days +/- 2 days after last CC-3 28 days after FU +/- 3 days
Safety 3-Hematology-White Blood Cells
WBC in \[cells/µl\]
Time frame: Day 1 Day 2 Day 3 Day 8 +/- 1 day Day 9 Day 15 +/- 1 day Every 7 days +/- 2 days after Treatment week 3 7 days +/- 2 days after last CC-3 28 days +/- 2 days after last CC-3 28 days after FU +/- 3 days
Started Jan 2024 (actual). Primary completion is estimated for Oct 2026, 33 months after the start.
Of 166 non-industry phase 1 interventional studies under Colorectal Neoplasms, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 31 and three quarters within 74. This study's planned 33 months is below that.
Counting every sponsor, half of 434 studies reached it within 48 months; a quarter within 31 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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