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NCT05765357
Clinical Study to Compare the Pharmacokinetics and Safety of Trastuzumab for Injection With Herceptin® in Healthy Male Volunteers
Phase 1 trial testing Trastuzumab for injection in Metastatic Breast Cancer in 89 participants. Completed in 27 October 2017.
27 October 2017
Quick facts
| Lead sponsor | Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 89 |
| Start date | 16 July 2017 |
| Primary completion | 27 October 2017 |
| Estimated completion | 27 October 2017 |
| Sites | 1 location across China |
Drugs / interventions tested
- Trastuzumab for injection — full drug profile →
- Herceptin (trastuzumab) — full drug profile →
Conditions studied
- Metastatic Breast Cancer — all drugs for Metastatic Breast Cancer →
- Metastatic Gastric Cancer — all drugs for Metastatic Gastric Cancer →
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. — full company profile →
Who can join
Adults 18 to 65, male only, with Metastatic Breast Cancer or Metastatic Gastric Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Trastuzumab for injection is a biosimilar of Herceptin ® produced by Chia Tai Tianqing Biotechnology Co., LTD, which is a humanized IgG1 monoclonal antibody produced by chinese hamster ovary (CHO) cells. A randomized, double-blind, single-dose, parallel phase I study comparing trastuzumab for injection with Herceptin ® in healthy male volunteers was conducted to evaluate the similarities in pharmacokinetics, tolerability, safety and immunogenicity of Trastuzumab for injection and Herceptin®.
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 NCT05765357
- 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 Chia Tai Tianqing Pharmaceutical Group Co., Ltd. trials
Trials by the same sponsor.
- NCT06990776 — A Clinical Trial to Evaluate the Efficacy and Safety of TQA3605 Tablets in Treatment-naive Chronic HBV-infected Subjects · Phase 2 · withdrawn
- NCT06851442 — Clinical Trial of Evaluating TQB3912 Tablets Combined With Fulvestrant Injection±TQB3616 Capsules for Locally Advanced o · Phase 1, PHASE2 · terminated
- NCT06711991 — A Clinical Trial of TQC3927 Powder for Inhalation in Chronic Obstructive Pulmonary Disease · Phase 1 · completed
- NCT06672276 — To Evaluate the Pharmacokinetics and Safety of TQD3606 for Injection in Subjects With Renal Insufficiency · Phase 1 · completed
- NCT06644417 — Clinical Study of TQA3605 Tablets Combined With Nucleoside (Acid) Analogs (NAs) Drugs Compared With NAs Drugs in the Tre · Phase 2 · 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 NCT05765357 (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 Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Last refreshed: 13 March 2023
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/NCT05765357.
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