Multiple MyelomaPhase 1NCT05271682
A Study Evaluating Safety, Tolerability and Clinical Activity of FHND6091 in Patients With Multiple Myeloma
A Phase 1 study testing FHND6091 in people with Multiple Myeloma, run by Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. at 6 sites in China.
Trial summary
This is a phase I, first in human, single arm, open label study that will assess safety, tolerability and clinical activity of FHND6091 when taken orally on a weekly dosing schedule by patients with relapsed and refractory multiple myeloma (RRMM).The study will consist of two parts: dose escalation (Part 1) and dose… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- FHND6091
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 6 sitesChina
- Study dates
- 22 Dec 2021to 31 Dec 2024
- 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
- Patients must give written informed consent.
- Male or female patients 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
- Life expectancy of at least 12 weeks.
- Patients with multiple myeloma who have relapsed or refractory, intolerance or refuse treatment following at least 3 regimens or lines of therapy that must include an IMID (lenalidomide or thalidomide), a proteasome inhibitor (bortezomib) , a CD38-targeted mAbs and corticosteroids. Patients must have received transplant therapy or are not suitable for transplant.
- For Patients With Relapsed Refractory Multiple Myeloma must have measurable disease defined by at least 1 of the following 2 measurements: Serum M-protein ≥ 5 g/L, or Urine M-protein ≥ 200 mg/24 hours. For patients with serum free light chain as measurable disease: Serum immunoglobulin free light chain ≥10 mg/dL and abnormal serum immunoglobulin kappa to lambda free light chain ratio.
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- Clinical laboratory values as specified below within 14 days before the first dose of study drug:
- Hemoglobin ≥ 75 g/L, Absolute neutrophil count ≥ 1.0 x 10E9/L and Platelet count ≥ 75 x 10E9/L without blood transfusion, EPO or G-CSF and other medical support for at least 14 days prior to receiving screening.
- Total bilirubin levels ≤ 2 x ULN, AST (SGOT) and ALT (SGPT) ≤ 2 x ULN.
- Calculated or measured creatinine clearance (CrCl) of ≥ 30 mL/minute as calculated by Cockcroft-Gault method.
- Corrected Serum Calcium ≤ ULN.
- For man and women of childbearing potential: agreement to remain abstinent or use contraception, during the treatment period (including treatment interruptions) and for at least 180 days after the last dose of FHND6091 was administered. Women of childbearing potential should be negative by serum pregnancy test within 7 days prior dosing.
Who cannot join
- Documented allergy to proteasome inhibitor or ；
- Patients with peripheral neuropathy ≥ Grade 2 or Grade 1 peripheral neuropathy with pain.
- Patients with diarrhea > Grade 1 (Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline).
- Patients received chemotherapy, radiation therapy, targeted therapy, immunotherapy or other systemic anticancer therapy within 14 days prior FHND6091 treatment.
- Patients received ixazomib treatment within 5 elimination half-life prior first dose of FHND6091 treatment.
- Patients received allogeneic stem cell transplantation or autologous stem cell transplant with 12 weeks before screening.
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- Patients with symptomatic brain metastases, leptomeningeal metastases or, spinal cord compression or central nervous system (CNS) injuries/abnormalities based on investigator judgement.
- Evidence of severe or uncontrolled systemic diseases (eg, unstable or uncompensated respiratory, hepatic or renal disease), or receive major surgery.
- Patients with unstable hypertension after drug treatment (SBP ≥140 mmHg, DBP ≥90 mmHg ) or heart failure, myocardial ischemia or myocardial infarction, unstable angina, arrhythmia (The corrected QT interval (Fridericia formula) interval (QTcF) > 470 msec for females and > 450 msec for men in electrocardiogram (ECG)).
- Patients with active, or a history of immunodeficiency, including HIV positive or other acquired and congenital immunodeficiency diseases, or a history of solid organ transplant.
- Patients with a history of other serious underlying diseases, such as: a, history of a clear neurological or psychiatric disorder, including epilepsy or dementia. b, HBV surface antigen positivity (subjects with documented laboratory evidence of HBV clearance may be enrolled) or positive HCV antibody. c, presence of infection requiring systemic treatment.
- Systemic treatment with strong inhibitors of of CYP3A4 or strong CYP3A4 inducers within 5 elimination half-life prior first dose of FHND6091 treatment.
- Patients have not recovered (ie, ≤ Grade 1 toxicity by CTCAE 5.0) from the reversible effects of prior antineoplastic therapy (except for alopecia )
- Patients with other malignancy；
- Treatment with any investigational products within 28 days before the first dose of study treatment
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
The first affiliated hospital of bengbu medical college
Bengbu, Anhui, 233000
Huan Zhou, Ph.D, 13665527160
Junfeng Zhu, MD
- Recruiting
The Third Hosptial of Changsha
Changsha, Hunan
Yu Cuihua, (0731) 8517 1463
shen Zengmei
- Recruiting
Ruijin Hospital
Shanghai, 200025
Meiwen Shu, 021-34188900, iec2020@rjh.com.cn
Jianqing Mi, M.D.
- Recruiting
Xi'an Central Hospital
Xi'an, Shaanxi
Zhang Yi, 029-81629000
Song Yanping, MD
- Recruiting
The Affilitated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Jiang Haijing, 0516-23698580
Yan Zhiling, MD
- Recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450003
Yuefang Chen, 0371-65588007, hnszlyygcp@163.com
Baijun Fang, M.D.
About this study
Official title: A Phase I Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of the FHND6091 in Subjects With Relapsed/Refractory Multiple Myeloma
This is a phase I, first in human, single arm, open label study that will assess safety, tolerability and clinical activity of FHND6091 when taken orally on a weekly dosing schedule by patients with relapsed and refractory multiple myeloma (RRMM).The study will consist of two parts: dose escalation (Part 1) and dose expansion (Part 2).The dose escalation (Part 1) of the study will evaluate the safety and tolerability of FHND6091 using a dose escalation scheme to establish a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). And the dose expansion (Part B) of the study will further evaluate the safety, pharmacokinetics (PK)/ pharmacodynamics (PD), and efficacy of FHND6091 at two selected dose levels to characterize the safety, tolerability and efficacy of FHND6091.
A total of 40 evaluable participants will be enrolled in the study. The participants receiving treatment in part 1 and part 2 may continue combination treatment for a total of up to 12 cycles. After 12 cycles of therapy, the participants will continue treatment until the occurrence of PD, intolerable AEs, consent withdrawal, death or end of study based on the judgement of investigator's assessment.
- Conditions
- Multiple Myeloma
- Being tested
- FHND6091
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FHND6091Drug
FHND6091 capsules
| Study group | Role | What they receive |
|---|---|---|
| Part 1: 0.4 mg | Experimental | FHND6091, 0.4 mg, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period Receives: Drug: FHND6091 |
| Part 1: 0.8 mg | Experimental | FHND6091, 0.8 mg, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period Receives: Drug: FHND6091 |
| Part 1: 1.4 mg | Experimental | FHND6091, 1.4 mg, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period Receives: Drug: FHND6091 |
| Part 1: 2.0 mg | Experimental | FHND6091, 2.0 mg, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period Receives: Drug: FHND6091 |
| Part 1: 2.8 mg | Experimental | FHND6091, 2.8 mg, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period Receives: Drug: FHND6091 |
| Part 1: 3.6 mg | Experimental | FHND6091, 3.6 mg, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period Receives: Drug: FHND6091 |
| Part 2: lower dose expansion | Experimental | FHND6091, a lower dose, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period Receives: Drug: FHND6091 |
| Part 2: MTD pr MTD-1 dose expansion | Experimental | FHND6091, MTD or MTD-1 dose, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period Receives: Drug: FHND6091 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting One or More Treatment-Emergent Adverse Events and Serious Adverse Events
An Adverse Event is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
A Serious Adverse Event (SAE) was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
Measured: Baseline to 28 days after first dose of FHND6091 administration
Secondary outcomes (6)
Complete Response/Stringent Complete Response (CR/sCR) Rate
CR/sCR to FHND6091, according to international myeloma working group (IMWG) criteria
Measured: Baseline to 12 months after first dose of FHND6091 administration
Rate of Very Good Partial Response (VGPR) or Better
VGPR to FHND6091, according to international myeloma working group (IMWG) criteria
Measured: Baseline to 12 months after first dose of FHND6091 administration
Partial Response (PR)
PR to FHND6091, according to international myeloma working group (IMWG) criteria
Measured: Baseline to 12 months after first dose of FHND6091 administration
Cmax: Maximum Observed Plasma Concentration for FHND6091
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve for FHND6091
Measured: Days 1 and 15 of Cycle 1 (each cycle is 28 days)
Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for FHND6091
Time to reach the maximum observed plasma concentration (Cmax), equal to time to Cmax
Measured: Days 1 and 15 of Cycle 1 (each cycle is 28 days)
AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for FHND6091
AUC(0-168) is a measure of the area under the plasma concentration-time curve over the dosing interval (tau) (AUC[0-tau]), where tau is the length of the dosing interval - 168 hours in this study)
Measured: Days 1 and 15 of Cycle 1 (each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start22 Dec 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianqin Mi, M.D., Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271682
- Sponsor's protocol ID
- LWY20071C
- Status last verified
- May 2023
- First submitted
- 17 Feb 2022
- Last updated
- 16 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Open-label, Dose Escalation Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Activity of the FHND6091 in Subjects With Relapsed/Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05271682
- Acronym / sponsor ID
- LWY20071C
- Conditions
- Multiple Myeloma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I, first in human, single arm, open label study that will assess safety, tolerability and clinical activity of FHND6091 when taken orally on a weekly dosing schedule by patients with relapsed and refractory multiple myeloma (RRMM).The study will consist of two parts: dose escalation (Part 1) and dose expansion (Part 2).The dose escalation (Part 1) of the study will evaluate the safety and tolerability of FHND6091 using a dose escalation scheme to establish a maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). And the dose expansion (Part B) of the study will further evaluate the safety, pharmacokinetics (PK)/ pharmacodynamics (PD), and efficacy of FHND6091 at two selected dose levels to characterize the safety, tolerability and efficacy of FHND6091.
A total of 40 evaluable participants will be enrolled in the study. The participants receiving treatment in part 1 and part 2 may continue combination treatment for a total of up to 12 cycles. After 12 cycles of therapy, the participants will continue treatment until the occurrence of PD, intolerable AEs, consent withdrawal, death or end of study based on the judgement of investigator's assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Part 1: 0.4 mg | Experimental | Drug: FHND6091FHND6091, 0.4 mg, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period |
| Part 1: 0.8 mg | Experimental | Drug: FHND6091FHND6091, 0.8 mg, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period |
| Part 1: 1.4 mg | Experimental | Drug: FHND6091FHND6091, 1.4 mg, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period |
| Part 1: 2.0 mg | Experimental | Drug: FHND6091FHND6091, 2.0 mg, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period |
| Part 1: 2.8 mg | Experimental | Drug: FHND6091FHND6091, 2.8 mg, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period |
| Part 1: 3.6 mg | Experimental | Drug: FHND6091FHND6091, 3.6 mg, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period |
| Part 2: lower dose expansion | Experimental | Drug: FHND6091FHND6091, a lower dose, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period |
| Part 2: MTD pr MTD-1 dose expansion | Experimental | Drug: FHND6091FHND6091, MTD or MTD-1 dose, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients must give written informed consent.
- Male or female patients 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
- Life expectancy of at least 12 weeks.
- Patients with multiple myeloma who have relapsed or refractory, intolerance or refuse treatment following at least 3 regimens or lines of therapy that must include an IMID (lenalidomide or thalidomide), a proteasome inhibitor (bortezomib) , a CD38-targeted mAbs and corticosteroids. Patients must have received transplant therapy or are not suitable for transplant.
Key exclusion criteria (15 listed)
- Documented allergy to proteasome inhibitor or ；
- Patients with peripheral neuropathy ≥ Grade 2 or Grade 1 peripheral neuropathy with pain.
- Patients with diarrhea > Grade 1 (Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline).
- Patients received chemotherapy, radiation therapy, targeted therapy, immunotherapy or other systemic anticancer therapy within 14 days prior FHND6091 treatment.
- Patients received ixazomib treatment within 5 elimination half-life prior first dose of FHND6091 treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FHND6091FHND6091 capsules | Drug | Part 1: 0.4 mg, Part 1: 0.8 mg, Part 1: 1.4 mg, Part 1: 2.0 mg, Part 1: 2.8 mg, Part 1: 3.6 mg, Part 2: MTD pr MTD-1 dose expansion, Part 2: lower dose expansion |
Primary outcome
Number of Participants Reporting One or More Treatment-Emergent Adverse Events and Serious Adverse Events
Time frame: Baseline to 28 days after first dose of FHND6091 administration
An Adverse Event is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. A Serious Adverse Event (SAE) was any experience that suggests a significant hazard, contraindication, side effect or precaution that: results in death, is life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically significant.
6 secondary outcomes
Complete Response/Stringent Complete Response (CR/sCR) Rate
Time frame: Baseline to 12 months after first dose of FHND6091 administration
Rate of Very Good Partial Response (VGPR) or Better
Time frame: Baseline to 12 months after first dose of FHND6091 administration
Partial Response (PR)
Time frame: Baseline to 12 months after first dose of FHND6091 administration
Cmax: Maximum Observed Plasma Concentration for FHND6091
Time frame: Days 1 and 15 of Cycle 1 (each cycle is 28 days)
Tmax: Time to Reach the Maximum Observed Plasma Concentration (Cmax) for FHND6091
Time frame: Days 1 and 15 of Cycle 1 (each cycle is 28 days)
AUC(0-168): Area Under the Plasma Concentration-Time Curve From Time 0 to 168 Hours Postdose for FHND6091
Time frame: Days 1 and 15 of Cycle 1 (each cycle is 28 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianqin Mi, M.D. principal investigator
Ruijin Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FHND6091 in people with Multiple Myeloma, run by Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. at 6 sites 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 12 inclusion and 15 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 16 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Contact Minghong Shang (025-57033246, shangmh@ctfh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Reporting One or More Treatment-Emergent Adverse Events and Serious Adverse Events (time frame: Baseline to 28 days after first dose of FHND6091 administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 May 2023.