Clinical trialPhase 1 / Phase 2Withdrawn
Phase 1/2a Study to Evaluate FL-301 in Patients With Advanced Solid Tumors
A Phase 1/2a, First-In-Human, Open Label, Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FL-301 in Patients With Advanced Solid Tumors
- Outcome
- Stopped earlySponsor Decision (Business decision)
- Phase
- Phase 1 / Phase 2
- Status
- Withdrawn
- Study type
- Interventional
- Start
- January 2022
- Expected end
- 18 January 2022
- Enrollment
- 0 participants
- Sites
- 0
- Primary outcomes
- Phase 1: The incidence of DLTs (during DLT observation period); Phase 2a (Expansion): ORR (CR + PR) assessed centrally by RECIST v1.1
- Sponsor
- Industry
- Results posted
- No
- Last update
- 7 February 2022
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Brief summary public domain (ClinicalTrials.gov)
This is a Phase 1/2a, first-in-human, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of FL-301 in patients with advanced cancer.
Detailed description public domain (ClinicalTrials.gov)
This is a Phase 1/2a, first-in-human, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of FL-301 in patients with advanced cancer. The study will consist of 2 phases, Phase 1 and Phase 2a. In Phase 1, dose escalation will proceed according to a rule-based design methodology. Phase 1 will explore dosing in which a single dose of FL-301 is administered by intravenous (IV) infusion every 2 weeks (Q2W) in 4-week cycles. Patients with measurable advanced solid tumors expressing claudin 18.2 may be enrolled, with the cutoff levels further defined in the eligibility criteria. Dose escalation methodology (modified 3+3 design) will utilize prespecified dose increments. Once the RP2D has been established, Phase 2a will commence to explore preliminary evidence of antitumor efficacy and confirm the safety of FL-301. The dosing schedule will be explored in up to 3 separate patient groups of approximately 30 patients per group. Group 1 will include patients with pancreatic cancer; Group 2 will include patients with gastric cancer (including gastroesophageal junction \[GEJ\]); and Group 3 will include patients with any other solid tumor (primarily non-small cell lung cancer \[NSCLC\], ovarian, and cholangiocarcinoma with claudin 18.2 expression). Response and progression will be evaluated in this study using computerized tomography (CT) or magnetic resonance imaging (MRI) imaging per RECIST v1.1. Long-term follow-up (survival and disease status, as applicable) will be conducted up to 18 months or until death, start of new anticancer therapy, end of study, or withdrawal of consent, whichever occurs first.