Last reviewed · How we verify
NCT00024687
Study of SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin in Advanced Malignancies: IV Infusion QOD x Six Doses
Phase 1 trial testing SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin 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 Withdrawn.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| Status | Withdrawn |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 November 2000 |
| Sites | 1 location across United States |
Drugs / interventions tested
- SS1(dsFv)-PE38 (SS1P) Anti-Mesothelin Immunotoxin — 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 contact Raffit Hassan, MD at 301-451-8742 for more information. Also see the related NCI study "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 once every other day for six doses. Dose escalation will proceed in cohorts of 3 until dose-limiting toxicity (DLT) is observed.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
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 NCT00024687
- 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.
- NCT03827642 — A Study to Compare Bioavailability of Naloxone Nasal Spray, Naloxone Hydrochloride (HCl) Intravenous (IV) and Intramuscu · Phase 1 · completed
- NCT02318563 — Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Dravet Syn · Phase 3 · withdrawn
- NCT02318537 — Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Lennox-Gas · Phase 3 · withdrawn
- NCT03254459 — Study of Buprenorphine Sublingual Spray Versus Standard of Care Narcotic Therapy for the Treatment of Post-Operative Pai · Phase 2 · completed
- NCT03827629 — A Study to Compare Bioavailability of Naloxone Nasal Spray and Naloxone Hydrochloride (HCl) Intramuscular Injection (IM) · Phase 1 · completed
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 NCT00024687 (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/NCT00024687.
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