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

NCT05181865 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: FL-301-1001
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Pancreas Cancer; Gastric Cancer; Solid Tumor

Keywords

FL-301; Pancreatic Cancer; Gastric Cancer; GEJ; Gastroesophageal Cancer; Solid Tumor; Claudin 18.2

Outcome Measures

Primary Outcomes (2)

• Phase 1: The incidence of DLTs (during DLT observation period)

  Determine the MTD, and/or to select an RP2D, and investigate the safety and tolerability of FL-301 in patients with advanced solid malignancies

  Up to 12 months

• Phase 2a (Expansion): ORR (CR + PR) assessed centrally by RECIST v1.1

  Assess the preliminary antitumor efficacy of FL-301, by central RECIST v1.1

  Up to 12 months

Secondary Outcomes (8)

• Phase 1: Incidence of patients with TEAEs and SAEs

  Up to 12 months

• Phase 1: Incidence of patients who develop ADAs and neutralizing ADAs during treatment with FL-301

  Up to 12 months

• Phase 1: ORR (CR + PR), DOR, and DCR assessed locally by RECIST v1.1

  Up to 12 months

• Phase 1: PK parameters - Cmax

  Up to 12 months

• Phase 1: PK parameters - Tmax

  Up to 12 months

Other Outcomes (2)

• Phase 1 (Exploratory): ORR (CR + PR), DOR, and DCR assessed centrally by RECIST v1.1

  Up to 12 months

• Phase 1 (Exploratory): Explore the predictive potential of biomarkers measured in blood and/or tumor tissue in response to FL-301

  Up to 12 months

Study Arms (8)

Phase 1 - Cohort 1

EXPERIMENTAL

Drug: 1 mg/kg IV FL-301

Phase 1 - Cohort 2

EXPERIMENTAL

Drug: 3 mg/kg IV FL-301

Phase 1 - Cohort 3

EXPERIMENTAL

Drug: 10 mg/kg IV FL-301

Phase 1 - Cohort 4

EXPERIMENTAL

Drug: 20 mg/kg IV FL-301

Phase 1 - Cohort 5

EXPERIMENTAL

Drug: 30 mg/kg IV FL-301

Phase 2a - Group 1

EXPERIMENTAL

Drug: RP2D, IV FL-301

Phase 2a - Group 2

EXPERIMENTAL

Drug: RP2D, IV FL-301

Phase 2a - Group 3

EXPERIMENTAL

Drug: RP2D, IV FL-301

Interventions

1 mg/kg IV FL-301 DRUG

N = 1

Also known as: FL-301

Phase 1 - Cohort 1

3 mg/kg IV FL-301 DRUG

N = 3-6

Also known as: FL-301

Phase 1 - Cohort 2

10 mg/kg IV FL-301 DRUG

N = 3-6

Also known as: FL-301

Phase 1 - Cohort 3

20 mg/kg IV FL-301 DRUG

N = 3-6

Also known as: FL-301

Phase 1 - Cohort 4

30 mg/kg IV FL-301 DRUG

N = 3-6

Also known as: FL-301

Phase 1 - Cohort 5

RP2D, IV FL-301 DRUG

Pancreatic Cancer N = 30

Also known as: FL-301

Phase 2a - Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Applicable to all patients in both the Phase 1 and Phase 2a parts of the study:
• Histological or cytologically confirmed locally advanced or metastatic solid tumor
• Life expectancy \>12 weeks.
• Age ≥18 years.
• ECOG performance status 0 or 1 at screening.
• Fully vaccinated against COVID-19 at least 3 weeks before C1D1. If under consideration for a booster, the booster administration needs to be complete within the same time constraint (ie, at least 3 weeks before C1D1).
• Adequate organ function, defined as:
• Hematology: defined as absolute neutrophil count (ANC) ≥1.5×109/L, platelet ≥90×109/L, hemoglobin ≥9.0 g/dL (in the absence of transfusion and use of growth factors within the last 14 days of screening labs).
• Renal function defined as calculated creatinine clearance (CCr) or radioisotope glomerular filtration rate \>60 mL/min/1.73 m2 calculated by Cockcroft-Gault formula or normal serum creatinine with a maximum serum creatinine of 1.5 mg/dL.
• Hepatic Function:
• Alanine aminotransferase (ALT) ≤2.5 × ULN; ≤5 × ULN if with liver metastases.
• Total bilirubin ≤1.5×ULN.
• Serum Electrolytes:
• Serum potassium, calcium, magnesium, and phosphate within normal limits or not worse than CTCAE v5.0 Grade 1 and asymptomatic. If values are low on the initial screening assessment, supplements may be given, if clinically appropriate, and values repeated to confirm within CTCAE v5.0 Grade 1 limits.
• Specific criteria for Phase 1:

You may not qualify if:

• Patients who meet any of the following criteria will be excluded:
• History of severe infusion reaction with monoclonal antibody treatment.
• Active or latent hepatitis B or active hepatitis C (test within 8 weeks of screening), or any uncontrolled infection at screening.
• Known history of HIV.
• Serious active infection at the time of treatment, or another serious underlying medical condition that would impair the ability of the patient to receive protocol treatment.
• Presence of other active cancers, or history of treatment for invasive cancer ≤3 years. Patients with Stage I cancer who have received definitive local treatment and are considered unlikely to recur are eligible. All patients with previously treated in situ carcinoma (ie, noninvasive) are eligible, as are patients with history of nonmelanoma skin cancer.
• Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol.
• Active central nervous system (CNS) disease involvement, defined by cerebrospinal fluid (CSF) cytology, magnetic resonance imaging (MRI) or computerized tomography (CT); patients with asymptomatic CNS metastases are eligible if they have been clinically stable for at least 4 weeks prior to the first dose of study drug and do not require interventions such as surgery, radiation or any corticosteroid therapy for management of symptoms related to CNS disease.
• Pregnant or nursing (lactating) women (Appendix B).
• Patients who received claudin 18.2 targeting agents previously.
• Prior radiotherapy:
• Non-CNS site of radiation must be completed \>2 weeks prior to FL-301 infusion
• CNS directed radiation must be completed \>4 weeks prior to FL-301 infusion as long as patients are asymptomatic post radiation therapy

Sponsors & Collaborators

• Flame Biosciences: lead

MeSH Terms

Conditions

Pancreatic Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Cassandra Choe-Juliak, MD

  Flame Biosciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 6, 2022
• Study Start: January 1, 2022
• Primary Completion: January 18, 2022
• Study Completion: January 18, 2022
• Last Updated: February 7, 2022

Record last verified: 2022-01