Targeted drug shows promise for rare bone cancer
NCT ID NCT05041127
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether cetuximab, a targeted antibody drug, can shrink tumors in people with advanced or metastatic chordoma, a rare type of bone cancer. About 29 adults with inoperable or spread chordoma will receive cetuximab intravenously. The main goal is to see how many patients respond to treatment, with safety also closely monitored.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cetuximab (a targeted antibody drug given intravenously)
- What this could lead to
- If successful, this could provide a new treatment option for people with advanced chordoma, a rare bone cancer with limited therapies.
- What could go wrong
- This is a small, early-phase trial with only 29 participants and no comparison group, so results may not be conclusive. Cetuximab can cause skin reactions and other side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
29 people
The number who actually took part.
- Started
-
May 2022
- Expected to finish
-
Sep 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Age ≥ 18 years * Histologically confirmed diagnosis of chordoma which is advanced (unresectable) and/or metastatic * ECOG Performance Status of ≤ 2 * At least one site of measurable disease on x-ray/CT/MRI and/or PET/CT scan as defined by RECIST 1.1 criteria. Baseline imaging must be performed within 30 days of Day 1 of study. * Adequate organ function within 28 days of Day 1 of study defined as: * The patient has adequate hematologic function, as evidenced by an absolute neutrophil count (ANC) ≥ 1000/µL, hemoglobin ≥ 9 g/dL (5.58 mmol/L), and platelets ≥ 100,000/µL * The patient has adequate hepatic function as defined by a total bilirubin ≤1.5 mg/dL (25.65 μmol/L) (NOTE: Patients with elevated bilirubin secondary to Gilbert's disease are eligible to participate in the study), and aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 times the upper Page 26 limit of normal (ULN; or 5.0 times the ULN in the setting of liver metastases). * The patient has adequate renal function as defined by a serum creatinine ≤1.5 times the ULN, or creatinine clearance (measured via 24-hour urine collection) ≥40 mL/minute (that is, if serum creatinine is \>1.5 times the ULN, a 24-hour urine collection to calculate creatinine clearance must be performed). 3.1.6 Patients may have any prior line of therapy, but there should a washout period of at least 3 weeks from any systemic therapy (small molecule/targeted agents, immunotherapies) and/or radiation therapy. * Patients should be completely recovered from any reversible toxicities associated with any prior therapies. * There should be access of archival tumor tissue for central pathology review, or a new tumor related biopsy should be considered within acceptable risk to the patient. * Patients must have no prior history of use of an EGFR inhibitor for treatment of their chordoma * Because the teratogenicity of cetuximab is not known, the patient, if sexually active, must be postmenopausal, surgically sterile, or using effective contraception (hormonal or barrier methods. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative serum pregnancy test ≤ seven days prior to Day 1 of study. * Life expectancy of \> 3 months Exclusion Criteria: * Prior use of an EGFR inhibitor for treatment of their chordoma * Non-metastatic, resectable disease * No measurable disease according to RECIST 1.1 * Life expectancy of less than 3 months * Other invasive malignancy within 2 years except for noninvasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured. * Concomitant participation to another clinical trial with active agent during the study (concomitant non-interventional study will be allowed) Page 27 * Patients who have a history of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab, red meat allergy, or tick bite history * Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol * The patient has clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency. * The patient has uncontrolled or poorly-controlled hypertension (\>180 mmHg systolic or \> 130 mmHg diastolic. * Major surgery within 4 weeks prior to Day 1 of study or who have not recovered adequately from prior surgery * Patients who have received wide field radiotherapy ≤ 3 weeks or limited field radiation for palliation \< 3 weeks prior to Day 1 of study or who have not recovered adequately from side effects of such therapy * Patients who have received any prior systemic therapy \< 3 weeks prior to Day 1 of study or have not recovered adequately from toxicities to the baseline. * Women who are pregnant or nursing/breastfeeding. * Inability to comply with protocol required procedures such as Medical, psychiatric, cognitive or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the study protocol or to complete the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
M D Anderson Cancer Center
Houston, Texas, 77030, United States
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