Trial Profile
A phase 1/2 dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics and preliminary efficacy of DTX-SPL8783 (a docetaxel (DTX)-dendrimer conjugate) as monotherapy in patients with advanced solid tumours or in combination with nintedanib in patients with non-small cell lung cancer (NSCLC)
Status:
Recruiting
Phase of Trial:
Phase I/II
Latest Information Update: 28 Aug 2023
Price :
$35
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At a glance
- Drugs Docetaxel (Primary) ; Nintedanib
- Indications Adenocarcinoma; Lung cancer; Non-small cell lung cancer; Solid tumours
- Focus Adverse reactions; First in man; Pharmacokinetics; Therapeutic Use
- Sponsors Starpharma
- 24 Aug 2023 According to a Starpharma media release, 50 patients were recruited and treated with DEP docetaxel in the monotherapy arm and Phase 2 results are expected in Q3 CY23, with partnering discussions ongoing.
- 27 Feb 2019 Interim results published in the Starpharma Financial Media Release
- 27 Feb 2019 According to a Starpharma media release, new sites opened to support recruitment (four sites in total). Patient enrollment has been completed in the first cohort of patients with lung cancer in the combination study of DEP docetaxel + nintedanib (Vargatef) and recruitment has been expanded in non-small cell lung cancer based on positive interim results. In the monotherapy arm, approximately 70% of patients in the initial cohort have been recruited.