NCT04189211

A Clinical Trial of BAT8001 on Safety, Tolerability and Pharmacokinetics for Patients

Status unknown Phase 1 Last updated 6 December 2019

What this trial tests

Phase 1 trial testing BAT8001 in HER2-Positive Solid Tumors in 30 participants. Status unknown.

Timeline

7 March 2017

Primary endpoint
31 December 2019

31 December 2020

Quick facts

Lead sponsor	Bio-Thera Solutions
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	7 March 2017
Primary completion	31 December 2019
Estimated completion	31 December 2020
Sites	1 location across China

Drugs / interventions tested

• BAT8001 — full drug profile →

Conditions studied

• HER2-Positive Solid Tumors — all drugs for HER2-Positive Solid Tumors →

Sponsor

Bio-Thera Solutions — full company profile →

Who can join

Adults 18 to 70, any sex, with HER2-Positive Solid Tumors. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

An Open-Label, Dose Escalation Phase I Clinical Trial on Safety, Tolerability and Pharmacokinetics of BAT8001 for Injection in Patients with HER2-Positive Solid Tumors (breast cancer or gastric cancer)。

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Antibody-Drug Conjugates for Cancer Therapy.
   Hafeez U, Parakh S, Gan HK, Scott AM. · · 2020 · cited 283× · PMID 33081383 · DOI 10.3390/molecules25204764
2. Targeting cancer with antibody-drug conjugates: Promises and challenges.
   Dean AQ, Luo S, Twomey JD, Zhang B. · · 2021 · cited 145× · PMID 34291723 · DOI 10.1080/19420862.2021.1951427
3. The Changing Paradigm for the Treatment of HER2-Positive Breast Cancer.
   Patel A, Unni N, Peng Y. · · 2020 · cited 91× · PMID 32731409 · DOI 10.3390/cancers12082081
4. HER2-directed antibodies, affibodies and nanobodies as drug-delivery vehicles in breast cancer with a specific focus on radioimmunotherapy and radioimmunoimaging.
   Altunay B, Morgenroth A, Beheshti M, Vogg A, et al · · 2021 · cited 74× · PMID 33179151 · DOI 10.1007/s00259-020-05094-1
5. Novel ADCs and Strategies to Overcome Resistance to Anti-HER2 ADCs.
   Díaz-Rodríguez E, Gandullo-Sánchez L, Ocaña A, Pandiella A. · · 2021 · cited 65× · PMID 35008318 · DOI 10.3390/cancers14010154
6. Beyond the Paclitaxel and Vinca Alkaloids: Next Generation of Plant-Derived Microtubule-Targeting Agents with Potential Anticancer Activity.
   Zhang D, Kanakkanthara A. · · 2020 · cited 46× · PMID 32610496 · DOI 10.3390/cancers12071721
7. Clinical perspective: Antibody-drug conjugates for the treatment of HER2-positive breast cancer.
   Najminejad Z, Dehghani F, Mirzaei Y, Mer AH, et al · · 2023 · cited 45× · PMID 36950736 · DOI 10.1016/j.ymthe.2023.03.019
8. Safety, tolerability, and pharmacokinetics of BAT8001 in patients with HER2-positive breast cancer: An open-label, dose-escalation, phase I study.
   Hong R, Xia W, Wang L, Lee K, et al · · 2021 · cited 21× · PMID 33528890 · DOI 10.1002/cac2.12135