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Phase 1/2a Study to Evaluate FL-301 in Patients With Advanced Solid Tumors

NCT05181865 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2022-02-07

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Flame Biosciences

    lead INDUSTRY

Principal Investigators

  • Cassandra Choe-Juliak, MD · Flame Biosciences

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-31
Primary Completion
2022-01-18
Completion
2022-01-18
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05181865 on ClinicalTrials.gov