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NCT00024674
Study of SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies: Continuous Infusion for 10 Days
Phase 1 trial testing SS1(dsFv)-PE38 in Neoplasms. Withdrawn.
Quick facts
| Lead sponsor | INSYS Therapeutics Inc |
|---|---|
| Phase | Phase 1 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Start date | 1 February 2001 |
| Sites | 1 location across United States |
Drugs / interventions tested
- SS1(dsFv)-PE38 — full drug profile →
Conditions studied
- Neoplasms — all drugs for Neoplasms →
Sponsor
INSYS Therapeutics Inc — full company profile →
Who can join
18 and older, any sex, with Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Although Neopharm has terminated its sponsorship of this study, it is continuing under the sponsorship of the NCI. Please see "Experimental Drug SS1(dsFv)-PE38 to Treat Cancer" (Study ID number 010011). SS1(dsFv)-PE38 is an oncology drug product containing a bacteria toxin, fused to a high affinity, disulfide stabilized antibody. The fused protein retains cell killing activity, but binds only to cells expressing mesothelin. Tumors characterized by very high surface mesothelin expression include mesothelioma; epithelial carcinomas of ovary and peritoneum; and squamous cancers of cervix and upper aerodigestive tract, including esophagus, head, and neck cancers. This is a dose-escalating study to determine the maximum tolerated dose (MTD) of intravenous SS1(dsFv)-PE38 administered continuously for 10 days every four weeks for a maximum of four courses of treatment. Dose escalation will proceed in cohorts of 3 until dose-limiting toxicity (DLT) is observed.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
<i>Pseudomonas</i> Exotoxin-Based Immunotoxins: Over Three Decades of Efforts on Targeting Cancer Cells With the Toxin.
Havaei SM, Aucoin MG, Jahanian-Najafabadi A. · · 2021 · cited 49× · PMID 34976821 · DOI 10.3389/fonc.2021.781800 -
Mesothelin biology and the evolving landscape of targeted immunotherapy.
Boisgard R, Chames P, Kerfelec B. · · 2026 · PMID 41994562 · DOI 10.1016/j.omton.2026.201148
Verify or expand the search:
- PubMed search for NCT00024674
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other INSYS Therapeutics Inc trials
Trials by the same sponsor.
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- NCT03254459 — Study of Buprenorphine Sublingual Spray Versus Standard of Care Narcotic Therapy for the Treatment of Post-Operative Pai · Phase 2 · completed
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00024674 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by INSYS Therapeutics Inc
- Last refreshed: 13 November 2014
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00024674.
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