Snake venom protein tested as cancer treatment in humans
NCT ID NCT01481532
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-stage trial tests crotoxin, a protein from rattlesnake venom, given intravenously to 24 adults with advanced solid tumors that have not responded to standard therapy. The main goal is to see if a slow dose increase can make the drug safer and better tolerated. Researchers will also watch for any signs that the drug might shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- crotoxin (a protein from rattlesnake venom)
- What this could lead to
- If it works, this could point toward a new way to control advanced cancers that have not responded to standard treatments.
- What could go wrong
- This is a very early, small Phase 1 trial with only 24 people. The main goal is safety, not yet proof that it shrinks tumors. Crotoxin has caused serious side effects in the past.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 24 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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.
Subjects will: 1. Be adult patients with histologically confirmed advanced solid tumors (excluding basal cell, colon, pancreatic and stomach cancers) who have progressed despite standard therapy, or for whom no standard therapy exists. 2. Have an ambulatory PS (ECOG 0-1). 3. Have tumor evaluation made within 28 days before study drug administration 4. Have completed radiotherapy or chemotherapy or any other anticancer therapy (including experimental therapy) more than 4 weeks prior to enrolment into the trial and must have recovered from all acute side effects of these treatments 5. Have a life expectancy greater than 3 months 6. Have an age ≥ 18 years 7. Have normal marrow function with the following haematological parameters normal; Hb ≥10g/dl, WBC ≥4.0 x10E9/L, neutrophil count ≥ 2.0 x 10E9/L and platelets ≥100 x10E9 /L 8. Have no medically significant impairment of cardiac or respiratory functions\< 9. Have adequate hepatic function with Total bilirubin 1.5 x N and Transaminases \< 2.5 x N (\< 5 x N in case of liver metastasis). 10. Have no history of prior severe allergic reactions to venoms 11. Have Creatinine clearance \> 50 mL/min. 12. Be on stable doses of any drugs which may affect hepatic drug metabolism or renal drug excretion (e.g.--non-steroidal anti-inflammatory drugs, barbiturates, narcotic analgesics, probenecid). Such drugs should not be initiated while the patient is participating in this study. 13. Not be pregnant or planning to become pregnant 14. Not known to have brain metastases or leptomeningeal involvement. CT-scan or MRI is not required to rule this out unless there is clinical suspicion of central nervous system involvement 15. Not have pleural effusion/ ascites, cystic lesions or bone metastases, as the only assessable lesions 16. Not have a history of other malignancies, except for patients with a cancer free interval of \> 5 years after treatment completion, patients with prior history of adequately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix 17. Not have had recent major surgery (within 21 days). 18. Not have a recent history of weight loss \> 10% of current body weight. 19. Not have serious intermittent medical illnesses which would interfere with the ability of the patient to carry out the treatment program. 20. Not be on chronic steroid medication (\> 20mg/day) 21. Not have primary or paraneoplastic myasthenia gravis 22. Be free of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; 23. Will agree to participate in the study prior to starting with any specific study procedure, after having signed written informed consent. 24. Be patients of childbearing age willing to use contraceptive for the duration of the study 25. Not live alone and live no further than approximately 30 km away from the hospital, and for the study duration have continuous access to the use of mobile telephone in case of medical emergency
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805, France
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