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

NCT ID: NCT04984434

Last Updated: 2021-07-30

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-30
• Study Completion Date: 2023-12-30

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.

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).

Conditions

Dose-Escalation Study, Relapsed or Refractory Multiple Myeloma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: Single Arm

Group Type: EXPERIMENTAL

F182112

Intervention Type: DRUG

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

Interventions

F182112

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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:

1. Relapsed after an autologous stem cell transplant (ASCT), or not suitable for ASCT;

2. 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;

5) Patients must have measurable disease, including at least one of the criteria below:

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1. M-protein ≥ 0.5 g/dL by SPEP/immunofixation or

2. ≥ 200 mg/24 hours urine collection by UPEP or

3. 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:

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1. Blood routine: absolute neutrophil count (ANC) ≥ 1.0×109/L, hemoglobin (Hb) ≥70g/L, Platelet ≥ 50×109/L;

2. Liver function: total bilirubin ≤ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) ≤ 2.5 × ULN, Aspartate aminotransferase (AST) ≤ 2.5 × ULN;

3. 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.

Exclusion Criteria

• 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;

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong New Time Pharmaceutical Co., LTD

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shaohong Yin

Linyi, Shandong, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Shaohong Yin

Role: primary

Other Identifiers

NTP-F182112-001

Identifier Type: -

Identifier Source: org_study_id