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Snake venom protein tested as cancer treatment in humans

NCT ID NCT01481532

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, 44805, France

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