AzTrials
AzTrials

Dose-Escalation Study, Relapsed or Refractory Multiple MyelomaPhase 1NCT04984434

Phase 1 Study of F182112 in Patients With Relapsed or Refractory Multiple Myeloma

A Phase 1 study testing F182112 in people with Dose-Escalation Study, Relapsed or Refractory Multiple Myeloma, run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This trial is a Multiple center, Open-label, dose escalation Phase Ⅰ clinical study. The purpose is to evaluate the safety and tolerability of F182112 when infused intravenously (IV) and determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of F182112 when infused IV. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
F182112
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteChina
Study dates
30 Jul 2021to 30 Dec 2023
Phase
Phase 1
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

  • 1) Willing and able to provide signed and dated informed consent prior to any study-related procedures and willing and able to comply with all study procedures;
  • 2) Male or female ≥ 18 years;
  • 3) Patient has a history of multiple myeloma with relapsed and refractory disease, and must:
  • Relapsed after an autologous stem cell transplant (ASCT), or not suitable for ASCT;
  • Must have received at least 2 prior multiple myeloma treatment regimens (not including autologous stem cell transplant) including a proteasome inhibitor, an immunomodulatory agent;
  • 4) ECOG of 0-2;
Show all 17Show fewer
  • 5) Patients must have measurable disease, including at least one of the criteria below:
  • <!-- -->
  • M-protein ≥ 0.5 g/dL by SPEP/immunofixation or
  • ≥ 200 mg/24 hours urine collection by UPEP or
  • Serum free light chain (FLC) levels > 100 mg/L (milligrams/liter involved light chain) and an abnormal kappa/lambda (κ/λ) ratio in patients without detectable serum or urine M-protein;
  • 6) Adequate hepatic function as evidenced by meeting all the following requirements:
  • <!-- -->
  • Blood routine: absolute neutrophil count (ANC) ≥ 1.0×109/L, hemoglobin (Hb) ≥70g/L, Platelet ≥ 50×109/L;
  • Liver function: total bilirubin ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 2.5 × ULN, Aspartate aminotransferase (AST) ≤ 2.5 × ULN;
  • Renal function: calculated creatinine clearance (CrCL) ≥ 30 mL/min (Cockroft-Gault Equation).
  • 7) Recovery to Grade 0-1 from adverse events related to prior anticancer therapy except alopecia, ≤ Grade 2 sensory neuropathy, lymphopenia, and endocrinopathies controlled with hormone replacement therapy.

Who cannot join

  • 1) Patient has primary light chain amyloidosis or plasma cell leukemia;
  • 2) Patient has symptomatic central nervous system involvement of multiple myeloma;
  • 3) Received systemic anti-myeloma therapy within 2 weeks, or received plasma exchange within 4 weeks;
  • 4) Received any experimental drugs within 4 weeks or 5 half-lives (whichever is shorter);
  • 5) Patient has received ≥ 40 mg/day dexamethasone equivalent within 7 days before starting F182112. Short term use of corticosteroids at doses equivalent to > 10 mg/d of prednisone；
  • 6) Received any monoclonal antibody therapy within 30 days;
Show all 21Show fewer
  • 7) Prior treatment with any B cell maturation antigen (BCMA) targeted therapy;
  • 8) Patient had a prior allogeneic stem cell transplant or had a prior autologous stem cell transplant ≤ 3 months prior to starting F182112;
  • 9) Live virus vaccine within 30 days prior to study entry;
  • 10) Major surgery within 4 weeks prior to study entry;
  • 11) Concurrent malignancy within 3 years prior to entry other than adequately treated cervical carcinoma-in-situ, localized squamous cell cancer of the skin, basal cell carcinoma, prostate cancer under active surveillance, prostate cancer that has undergone definitive treatment, ductal carcinoma in situ of the breast, or ≤ T1 urothelial carcinoma;
  • 12) Patients with active mucosa or visceral bleeding;
  • 13) Severe cardiovascular disease, including CVA, TIA, myocardial infarction, or unstable angina within 6 months of study entry; NYHA class III or IV heart failure within 6 months of study entry; Uncontrolled arrhythmia within 6 months of study entry. Patients with a rate-controlled arrhythmia may be eligible for study entry at the discretion of the Medical Monitor;
  • 14) Active infection requiring antibiotic, antiviral or antifungul therapy;
  • 15) Active viral hepatitis;
  • 16) Has a history of immunodeficiency, include HIV infection;
  • 17) Treponema pallidum infection;
  • 18) Received any experimental drugs or anti-tumor drugs within 2 weeks;
  • 19) Subject has any condition that confounds the ability to interpret data from the study;
  • 20) Females and males must practice true abstinence or agree to contraceptive methods throughout the study, and 6 months after the last giving F182112;
  • 21) Any condition that the investigator or primary physician believes may not be appropriate for participating the study.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • Shaohong Yin

    Linyi, Shandong, 276006

    Shaohong Yin, 86-15265901803, yinshaohong@lunan.com.cn

    JunYuan Qi, Doctor

    Recruiting

Other trials in China

About this study

Official title: A First-in-human, Open-label, Multiple Center Phase 1 Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetic, Immunogenicity, and Preliminary Efficacy of F182112 in Patients With Relapsed or Refractory Multiple Myeloma.

This trial is a Multiple center, Open-label, dose escalation Phase Ⅰ clinical study. The purpose is to evaluate the safety and tolerability of F182112 when infused intravenously (IV) and determine the maximum tolerated dose (MTD) and/or the recommended Phase 2 dose (RP2D) of F182112 when infused IV.

Read the detailed description

To assess the safety, tolerability, and dose-limiting toxicities (DLTs) and to determine a recommended phase 2 dose regimen (RP2DR) of F182112 as monotherapy in patients with relapsed or refractory multiple myeloma (MM).

Being tested
F182112
Medical subject headings
Recurrence, Multiple Myeloma

What participants receive

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

  • F182112Drug

    Eight dose cohorts: 0.01, 0.1, 0.3, 1, 3, 10, 20 and 30 μg/kg) d1 treat every weeks.

Study groups in NCT04984434
Study groupRoleWhat they receive
Experimental: Single ArmExperimentalNot described
Receives: Drug: F182112

What is being measured

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

  1. DLTs

    Incidence of dose-limiting toxicities (DLTs) from the first dose through the end of the DLT observation period

    Measured: Up to 28 days

  2. Maximum Tolerated Dose (MTD)

    Maximum Tolerated Dose

    Measured: Approximately 12 months

  3. RP2D

    Preliminary Antitumor Activity of F182112 at the RP2D(s) in Part 2

    Measured: Approximately 12 months

Secondary outcomes (3)

  1. Overall survival (OS)

    To evaluate the duration from the first dose to death of patients with MM for any reason.

    Measured: Approximately 24 months

  2. Progression-free survival (PFS)

    Evaluation of the efficacy of F182112 in patients with MM on progression-free survival.

    Measured: Approximately 24 months

  3. Objective response rate (ORR)

    Objective remission rate was used to evaluate the efficacy of F182112 injection in patients with MM.

    Measured: Approximately 24 months

Timeline

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

  1. First posted30 Jul 2021
  2. Study start30 Jul 2021 (estimated)
  3. Primary completion30 Jul 2023 (estimated)
  4. Study completion30 Dec 2023 (estimated)

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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
68 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04984434
Sponsor's protocol ID
NTP-F182112-001
Status last verified
Jul 2021
First submitted
21 Jul 2021
Last updated
30 Jul 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing F182112 in people with Dose-Escalation Study, Relapsed or Refractory Multiple Myeloma, run by Shandong New Time Pharmaceutical Co., LTD at 1 site in China.

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 17 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 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.

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

Are results available for this study?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

DLTs (time frame: Up to 28 days). The study lists 3 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 NCT04984434.

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 30 Jul 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in