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CancerPhase 1NCT01481532

Open Label Clinical Trial of Intravenous Crotoxin Part 3

A Phase 1 study testing Crotoxin in people with Cancer, run by Celtic Biotech Ltd at 1 site in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The primary objective of the study is to assess whether human subjects can be made tolerant to intravenously administered Crotoxin and achieve higher and more therapeutically effective doses levels without the previously reported adverse effects associated with bolus i.m. administration. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Cancer
What is being tested?
Crotoxin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteFrance
Study dates
Oct 2026to Nov 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Dorothy Bray, Ph.D. contact

+447884005367

dorothy.bray@celticbiotech.com

France1 site

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, 44805

Other trials in France

About this study

Official title: Open Label Phase I Clinical Trial of Crotoxin in Patients With Advanced Cancer Using an Intravenous Route of Administration

The primary objective of the study is to assess whether human subjects can be made tolerant to intravenously administered Crotoxin and achieve higher and more therapeutically effective doses levels without the previously reported adverse effects associated with bolus i.m. administration.

Read the detailed description

Crotoxin has been shown to induce neurotoxic tolerance in animals allowing them to receive high doses associated with effective anti-tumor activity in the absence of adverse side effects.

The study plans to demonstrate this effect in human subjects using two dose escalation protocols; slow and fast. It is believed that this approach will prevent toxic side effects to subjects.

The route of administration has not been employed clinically and is designed to avoid the myonecrotic effects of intramuscular injections. The target maximum dose is almost five times that of the previously reported MTD.

The revised protocol incorporates continuous infusion with a mobile pump and includes active suppression of the allergic reaction by pre-treatment administration of antihistamines.

Conditions
Cancer
Being tested
Crotoxin
Keywords
Antineoplastic agent
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CrotoxinDrug

    Also called CB-24

    Intra patient dose escalation

Study groups in NCT01481532
Study groupRoleWhat they receive
Cohort 3ExperimentalThe third cohort will include up to 24 patients with Crotoxin doses of 0.2 to 1.32 mg per m2 in which the dose escalation speed will be faster. Drug is administered over 3 + 4 day intervals using ambulatory infusion pumps; treating on an outpatient basis. Subjects will receive increasing doses over the course of 28 treatment days (8 dose levels). Dose escalation will continue if DLT is not established
Receives: Drug: Crotoxin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Tolerability of intra-patient dose escalation

    Assess the safety and tolerability of Crotoxin administered intravenously to Stage IV cancer patients using intra-patient dose escalation procedure.

    Measured: 28 days

  2. Confirmation of the induction of drug tolerance

    Confirm in a controlled phase I trial that human subjects can be made tolerant to intravenously administered Crotoxin thereby reducing the potential for adverse drug effects

    Measured: 28 days

Secondary outcomes (1)

  1. Assessment of drug efficacy

    Document any objective anti-tumour responses that occur in patients treated on this protocol.

    Measured: 112 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2011 (estimated)
  2. Study startOct 2026 (estimated)
  3. Primary completionOct 2027 (estimated)
  4. Study completionNov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Phase Ic, continuation to assess accelerated dose escalation and determine MTD
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01481532
Sponsor's protocol ID
CRTX01
Status last verified
Apr 2026
First submitted
11 Oct 2011
Last updated
15 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Delgado MG, Gougis P, Bray DH, Delgado FM, Spano JP, Idbaih A, Reid PF, Benlhassan K, Diaw C, Khayat D. Abstract CT071: Continuous i.v. Crotoxin in advanced cancer: Intra-patient dose escalation. Cancer Res (2018) 78 (13_Supplement): CT071. https://doi.org/10.1158/1538-7445.AM2018-CT071

  • Medioni J, Brizard M, Elaidi R, Reid PF, Benlhassan K, Bray D. Innovative design for a phase 1 trial with intra-patient dose escalation: The Crotoxin study. Contemp Clin Trials Commun. 2017 Jul 23;7:186-188. doi: 10.1016/j.conctc.2017.07.008. eCollection 2017 Sep.

    PubMed 29696184

  • Gil-Delgado M, Paul G, Bray DH, Delgado F, Spano JP, Idbaih A, Reid PF, Benlhassan K, Diaw C, Khayat D. Continuous i.v. Crotoxin in advanced cancer: Intra-patient dose escalation. Cancer Res (2018) 78 (13_Supplement): CT071.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Crotoxin in people with Cancer, run by Celtic Biotech Ltd at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Dorothy Bray, Ph.D. (+447884005367, dorothy.bray@celticbiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tolerability of intra-patient dose escalation (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01481532, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2026.

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