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

NCT04984434 | Unknown Phase 1 DMC

• 1 other identifier: NTP-F182112-001
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dose-Escalation Study, Relapsed or Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (3)

• DLTs

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

  Up to 28 days

• Maximum Tolerated Dose (MTD)

  Maximum Tolerated Dose

  Approximately 12 months

• RP2D

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

  Approximately 12 months

Secondary Outcomes (3)

• Overall survival (OS)

  Approximately 24 months

• Progression-free survival (PFS)

  Approximately 24 months

• Objective response rate (ORR)

  Approximately 24 months

Other Outcomes (1)

• Minimal Residual Disease (MRD) Negative Rate

  Approximately 24 months

Study Arms (1)

Experimental: Single Arm

EXPERIMENTAL

Drug: F182112

Interventions

F182112 DRUG

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

Experimental: Single Arm

Eligibility Criteria

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

You may qualify if:

• \) 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;
• \) Male or female ≥ 18 years;
• \) 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;
• \) ECOG of 0-2;
• \) Patients must have measurable disease, including at least one of the criteria below:
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• 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;
• \) Adequate hepatic function as evidenced by meeting all the following requirements:
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• 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;

You may not qualify if:

• \) Patient has primary light chain amyloidosis or plasma cell leukemia;
• \) Patient has symptomatic central nervous system involvement of multiple myeloma;
• \) Received systemic anti-myeloma therapy within 2 weeks, or received plasma exchange within 4 weeks;
• \) Received any experimental drugs within 4 weeks or 5 half-lives (whichever is shorter);
• \) 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；
• \) Received any monoclonal antibody therapy within 30 days;
• \) Prior treatment with any B cell maturation antigen (BCMA) targeted therapy;
• \) Patient had a prior allogeneic stem cell transplant or had a prior autologous stem cell transplant ≤ 3 months prior to starting F182112;
• \) Live virus vaccine within 30 days prior to study entry;
• \) Major surgery within 4 weeks prior to study entry;
• \) 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;
• \) Patients with active mucosa or visceral bleeding;
• \) 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;
• \) Active infection requiring antibiotic, antiviral or antifungul therapy;
• \) Active viral hepatitis;

Sponsors & Collaborators

• Shandong New Time Pharmaceutical Co., LTD: lead

Study Sites (1)

Shaohong Yin

Linyi, Shandong, 276006, China

RECRUITING

MeSH Terms

Conditions

Recurrence; Multiple Myeloma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2021
• First Posted: July 30, 2021
• Study Start: July 30, 2021
• Primary Completion: July 30, 2023
• Study Completion: December 30, 2023
• Last Updated: July 30, 2021

Record last verified: 2021-07

Locations

CN (1)