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NCT06886659
A Study to Compare PK, Immunogenicity and Safety of Trastuzumab of Incepta Pharmaceuticals Ltd With Trastuzumab (Roche)
Phase 1 trial testing Trastuzumab (proposed Trastuzumab biosimilar) in Breast Cancer in 80 participants. Completed in 28 December 2024.
28 December 2024
Quick facts
| Lead sponsor | Incepta Pharmaceuticals Ltd |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 80 |
| Start date | 23 January 2024 |
| Primary completion | 28 December 2024 |
| Estimated completion | 28 December 2024 |
| Sites | 2 locations across Bangladesh |
Drugs / interventions tested
- Trastuzumab (proposed Trastuzumab biosimilar) — full drug profile →
- Herclon — full drug profile →
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Breast Neoplasms — all drugs for Breast Neoplasms →
- Breast Disease — all drugs for Breast Disease →
- Antineoplastic Agents — all drugs for Antineoplastic Agents →
Sponsor
Incepta Pharmaceuticals Ltd — full company profile →
Who can join
Adults 18 to 55, male only, with Breast Cancer or Breast Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Trastuzumab is an Ig G1 kappa, humanized monoclonal antibody which is most abundant subclass of IgG, that works against overexpress of HER2 (Human Epidermal Growth Factor Receptor Type 2). Trastuzumab is used to treat HER2-positive breast, gastroesophageal, and gastric cancers. HER2 regulate cell growth and survival, as well as adhesion, migration, differentiation and other cellular response. But when HER2 signaling is over expressed it causes uncontrolled cell growth which leads to the formation of cancerous tumor.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT06886659
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Incepta Pharmaceuticals Ltd trials
Trials by the same sponsor.
- NCT07025681 — PK, PD, Safety and Immunogenicity Study of Erythropoietin of Incepta Pharmaceuticals Ltd With Eprex (Janssen-Cilag). · Phase 3 · recruiting
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 NCT06886659 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Incepta Pharmaceuticals Ltd
- Last refreshed: 22 July 2025
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/NCT06886659.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing