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AzTrials

Pancreas CancerPhase 1/2NCT05181865

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

A Phase 1/2 study testing 1 mg/kg IV FL-301, 3 mg/kg IV FL-301 and 10 mg/kg IV FL-301 in people with Pancreas Cancer and Gastric Cancer, run by Flame Biosciences.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreas Cancer, Gastric Cancer, Solid Tumor
What is being tested?
1 mg/kg IV FL-301, 3 mg/kg IV FL-301 and 10 mg/kg IV FL-301
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jan 2022to 18 Jan 2022
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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.
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  • 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

About this study

Official title: 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

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.

Read the 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.

Being tested
1 mg/kg IV FL-301, 3 mg/kg IV FL-301, 10 mg/kg IV FL-301, 20 mg/kg IV FL-301, 30 mg/kg IV FL-301
Keywords
FL-301, Pancreatic Cancer, Gastric Cancer, GEJ, Gastroesophageal Cancer, Solid Tumor, Claudin 18.2
Medical subject headings
Pancreatic Neoplasms, Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1 mg/kg IV FL-301Drug

    Also called FL-301

    N = 1

  • 3 mg/kg IV FL-301Drug

    Also called FL-301

    N = 3-6

  • 10 mg/kg IV FL-301Drug

    Also called FL-301

    N = 3-6

  • 20 mg/kg IV FL-301Drug

    Also called FL-301

    N = 3-6

  • 30 mg/kg IV FL-301Drug

    Also called FL-301

    N = 3-6

  • RP2D, IV FL-301Drug

    Also called FL-301

    Pancreatic Cancer N = 30

  • RP2D, IV FL-301Drug

    Also called FL-301

    Gastric Cancer (Including GEJ) N = 30

  • RP2D, IV FL-301Drug

    Also called FL-301

    Other Solid Tumors N = 30

Study groups in NCT05181865
Study groupRoleWhat they receive
Phase 1 - Cohort 1ExperimentalNot described
Receives: Drug: 1 mg/kg IV FL-301
Phase 1 - Cohort 2ExperimentalNot described
Receives: Drug: 3 mg/kg IV FL-301
Phase 1 - Cohort 3ExperimentalNot described
Receives: Drug: 10 mg/kg IV FL-301
Phase 1 - Cohort 4ExperimentalNot described
Receives: Drug: 20 mg/kg IV FL-301
Phase 1 - Cohort 5ExperimentalNot described
Receives: Drug: 30 mg/kg IV FL-301
Phase 2a - Group 1ExperimentalNot described
Receives: Drug: RP2D, IV FL-301
Phase 2a - Group 2ExperimentalNot described
Receives: Drug: RP2D, IV FL-301
Phase 2a - Group 3ExperimentalNot described
Receives: Drug: RP2D, IV FL-301

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Up to 12 months

  2. 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

    Measured: Up to 12 months

Secondary outcomes (8)

  1. Phase 1: Incidence of patients with TEAEs and SAEs

    Characterize the safety and tolerability of FL-301

    Measured: Up to 12 months

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

    Characterize the immunogenicity of FL-301

    Measured: Up to 12 months

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

    Assess the preliminary antitumor efficacy of FL-301

    Measured: Up to 12 months

  4. Phase 1: PK parameters - Cmax

    Characterize the PK of FL-301

    Measured: Up to 12 months

  5. Phase 1: PK parameters - Tmax

    Characterize the PK of FL-301

    Measured: Up to 12 months

  6. Phase 1: PK parameters - AUC (0-∞)

    Characterize the PK of FL-301

    Measured: Up to 12 months

  7. Phase 1: PK parameters - AUC (0-τ)

    Characterize the PK of FL-301

    Measured: Up to 12 months

  8. Phase 1: PK parameters - Half-life (t1/2)

    Characterize the PK of FL-301

    Measured: Up to 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2022
  2. Study startJan 2022 (estimated)
  3. Primary completion18 Jan 2022
  4. Study completion18 Jan 2022

Why it stopped: Sponsor Decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05181865
Sponsor's protocol ID
FL-301-1001
Status last verified
Jan 2022
First submitted
17 Dec 2021
Last updated
7 Feb 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 1 mg/kg IV FL-301, 3 mg/kg IV FL-301 and 10 mg/kg IV FL-301 in people with Pancreas Cancer and Gastric Cancer, run by Flame Biosciences.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 7 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1: The incidence of DLTs (during DLT observation period) (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05181865.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2022.

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