NCT05181865

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Flame Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Pancreas Cancer
• Gastric Cancer
• Solid Tumor

Interventions

Type	Name	Description
DRUG	1 mg/kg IV FL-301	N = 1
DRUG	3 mg/kg IV FL-301	N = 3-6
DRUG	10 mg/kg IV FL-301	N = 3-6
DRUG	20 mg/kg IV FL-301	N = 3-6
DRUG	30 mg/kg IV FL-301	N = 3-6
DRUG	RP2D, IV FL-301	Pancreatic Cancer N = 30
DRUG	RP2D, IV FL-301	Gastric Cancer (Including GEJ) N = 30
DRUG	RP2D, IV FL-301	Other Solid Tumors N = 30

Timeline

• Start date: 2022-01-01
• Primary completion: 2022-01-18
• Completion: 2022-01-18
• First posted: 2022-01-06
• Last updated: 2022-02-07

Regulatory

• FDA-regulated drug study