Relapsed and/or Refractory Multiple MyelomaPhase 1/2NCT05719701
Evaluate the Safety, Tolerability, and Efficacy of ICP-490 in Patients With Relapsed and/or Refractory Multiple Myeloma
A Phase 1/2 study testing ICP-490 and Dexamethasone in people with Relapsed and/or Refractory Multiple Myeloma, run by Beijing InnoCare Pharma Tech Co., Ltd. at 6 sites in China.
Trial summary
This is a multi-center, non-randomized and open-label phase I/IIa clinical study to evaluate the safety, tolerability, and efficacy of ICP-490 in patients with relapsed and/or refractory multiple myeloma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Relapsed and/or Refractory Multiple Myeloma
- What is being tested?
- ICP-490 and Dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 6 sitesChina
- Study dates
- 29 Mar 2023to 30 Dec 2025
- 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
- Aged ≥ 18 years old.
- Diagnosed as relapsed and/or refractory multiple myeloma .The patient must have measurable diseases.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.
- Patients must have adequate organ function. Expected survival time ≥ 6 months.
- All toxicities caused by prior anticancer therapy must have recovered to Grade ≤ 1 (based on CTCAE v5.0) except alopecia and fatigue.
- Female patients of childbearing potential should have a negative blood pregnancy test result within 48 h prior to the first dose of investigational drug.
Who cannot join
- Known active central nervous system (CNS) involvement or history of the disease, or clinical signs of multiple myeloma meningeal/spinal meningeal involvement.
- Patients with solitary plasmacytoma; plasma cell leukemia (PCL) (active PCL or history of PCL); Waldenström's macroglobulinemia; POEMS syndrome or symptomatic amyloidosis.
- Prior active or history of malignancies other than MM, occurring within 5 years prior to the first dose of investigational drug, with the exception of radically treated local curable cancers.
- Uncontrolled or severe cardiovascular disorders.
- Any active infection within 14 days prior to the first dose of investigational drug.
- Patients with diseases restricted from participation as described in the protocol
Show all 12Show fewer
- Having undergone major surgery within 28 days prior to the first dose of investigational drug, or minor surgery within 2 weeks prior to the first dose. Any severe or uncontrolled systemic disease evaluated by investigatorthat may increase the risk associated with study participation and drug administration or affect the patient's ability to receive the investigational drug.
- Patients who have received any other systemic treatment, anti-tumor traditional Chinese (herbal) medicine therapy , and any other investigational drug therapy for MM within 28 days or 5 half-lives of the drugs (whichever is shorter) prior to the first dose of investigational drug.
- Patients who have received systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days prior to the first dose of investigational drug.
- Subjects are allowed to use topical, ocular, intra-articular, intranasal, and inhaledcorticosteroid ; short-term use (≤ 7 days) of corticosteroid for prophylaxis (e.g., contrast agent allergy) or for the treatment of non-autoimmune diseases (e.g., delayed hypersensitivity reaction caused by contact allergens) is permitted.
- Patients who have received medications or foods with strong inhibitory or inductive effects on cytochrome P450 CYP3A, and proton pump inhibitorswithin 2 weeks prior to the first dose of investigational drug, or are planning to receive them during the study.
- Patients with a history of severe allergic reactions to IMIDs , or dexamethasone, or to any component contained in ICP-490 or dexamethasone formulation (CTCAE V5.0 Grade > 3).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Xiaojun Huang, PhD
- Not yet recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510120
Yang Liang
- Not yet recruiting
The First Affiliated Hospital，Zhejiang University School of Medicine
Hangzhou, Zhejiang
Zhen Cai, PhD
- Not yet recruiting
Renji Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Lijing Shen
- Not yet recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning
Aijun Liao, PhD
- Not yet recruiting
Henan Cancer Hosptital
Zhengzhou, Henan
Baijun Fang
About this study
Official title: A Multi-center, Non-randomized, and Open-label Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of ICP-490 in Patients With Relapsed and/or Refractory Multiple Myeloma
This is a multi-center, non-randomized and open-label phase I/IIa clinical study to evaluate the safety, tolerability, and efficacy of ICP-490 in patients with relapsed and/or refractory multiple myeloma.
- Being tested
- ICP-490, Dexamethasone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP-490Drug
Several dose groups of ICP-490 are planned for the dose exploration.
DexamethasoneDrug
Oral Dexamethasone is administered on Days 1, 8, 15, and 22 of each 28-day cycle.
| Study group | Role | What they receive |
|---|---|---|
| ICP-490 | Experimental | Not described Receives: Drug: ICP-490 |
| ICP-490 in combination with Dexamethasone | Experimental | Not described Receives: Drug: ICP-490; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I : Incidence, type, and severity of adverse events (AEs) as judged according to NCI-CTCAE V5.0
AE refers to any adverse event occurring in subjects during clinical research period. The incidence and type of AEs will be evaluated and the severity will be judged according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version5.0.
Measured: Through study completion, an average of 3 years
Phase I : Incidence, type, and severity of dose-limiting toxicities (DLTs)
The dose-limiting toxicity (DLT) assessed in the phase I dose exploration study is defined as AEs related to study treatment that meet the following criteria (according to the NCI CTCAE v5.0 criteria) and occur in Cycle 1.
Measured: Through study completion, an average of 3 years
Phase I : RP2Ds and/or MTDs
Phase I is the dose exploration study of ICP-490 to preliminarily determine RP2Ds (probably more than one) and MTD (if applicable). MTD: The dose level corresponding to the dose group whose posterior probability of DLT incidence estimated by PAVA (pool adjacent violators algorithm) is closest to the target toxicity probability (25%).
Measured: Through study completion, an average of 3 years
Phase II : ORR (defined as sCR + CR + VGPR + PR) assessed according to IMWG criteria.
Disease response will be assessed according to the 2016 IMWG response criteria.
Measured: Through study completion, an average of 3 years
Secondary outcomes (14)
Maximum concentration (Cmax)
Maximum concentration (Cmax) will be calculated through multiple plasma concentrations drawn from the patients after administration.
Measured: Through study completion, an average of 3 years
Time to maximum concentration (Tmax)
Time to maximum concentration (Tmax) will be calculated through multiple plasma concentrations drawn from the patients after administration.
Measured: Through study completion, an average of 3 years
Half-life (T1/2)
Half-life (T1/2) will be calculated through multiple plasma concentrations drawn from the patients after administration.
Measured: Through study completion, an average of 3 years
Area under the concentration-time curve (AUC0-∞ and AUC0-t)
Area under the concentration-time curve (AUC0-∞ and AUC0-t) will be calculated through multiple plasma concentrations drawn from the patients after administration.
Measured: Through study completion, an average of 3 years
Apparent clearance (CL/F)
Apparent clearance (CL/F) will be calculated through multiple plasma concentrations drawn from the patients after administration.
Measured: Through study completion, an average of 3 years
Apparent volume of distribution during terminal phase (Vz/F)
Apparent volume of distribution during terminal phase (Vz/F) will be calculated through multiple plasma concentrations drawn from the patients after administration.
Measured: Through study completion, an average of 3 years
Steady-state PK parameters
Steady-state PK parameters will be calculated through multiple plasma concentrations drawn from the patients after administration.
Measured: Through study completion, an average of 3 years
The overall response rate (ORR) assessed according to the International Myeloma Working Group (IMWG) criteria (ORR, defined as stringent complete response (sCR) + complete response (CR) + very good partial response (VGPR) + partial response (PR))
Disease response will be assessed according to the 2016 IMWG response criteria.
Measured: Through study completion, an average of 3 years
Phase I & IIa : Complete response rate (CRR, defined as sCR + CR) assessed according to IMWG criteria
Disease response will be assessed according to the 2016 IMWG response criteria.
Measured: Through study completion, an average of 3 years
Phase I & IIa : Very good or better partial response rate assessed according to IMWG criteria (≥ VGPR rate, defined as VGPR + sCR + CR)
Disease response will be assessed according to the 2016 IMWG response criteria.
Measured: Through study completion, an average of 3 years
Phase I & IIa : Time to response (TTR) assessed according to IMWG criteria
Disease response will be assessed according to the 2016 IMWG response criteria
Measured: Through study completion, an average of 3 years
Phase I & IIa : Duration of response (DOR) assessed according to IMWG criteria
Disease response will be assessed according to the 2016 IMWG response criteria
Measured: Through study completion, an average of 3 years
Phase I & IIa : Progression-free survival (PFS) assessed according to IMWG criteria
Disease response will be assessed according to the 2016 IMWG response criteria
Measured: Through study completion, an average of 3 years
Phase I & IIa : Overall survival (OS)
The follow-up visits should be carried out every 12 weeks after the last dose via telephone or other methods to obtain the survival status information of patients.
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start29 Mar 2023
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed and/or Refractory Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Beijing InnoCare Pharma Tech Co., Ltd.The sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05719701
- Sponsor's protocol ID
- ICP-CL-01101
- Status last verified
- Mar 2024
- First submitted
- 10 Jan 2023
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Non-randomized, and Open-label Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of ICP-490 in Patients With Relapsed and/or Refractory Multiple Myeloma
- ClinicalTrials.gov ID
- NCT05719701
- Acronym / sponsor ID
- ICP-CL-01101
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Mar 2023 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 9 Feb 2023 (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 multi-center, non-randomized and open-label phase I/IIa clinical study to evaluate the safety, tolerability, and efficacy of ICP-490 in patients with relapsed and/or refractory multiple myeloma.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICP-490 | Experimental | Drug: ICP-490 |
| ICP-490 in combination with Dexamethasone | Experimental | Drug: ICP-490, Drug: Dexamethasone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged ≥ 18 years old.
- Diagnosed as relapsed and/or refractory multiple myeloma .The patient must have measurable diseases.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2.
- Patients must have adequate organ function. Expected survival time ≥ 6 months.
- All toxicities caused by prior anticancer therapy must have recovered to Grade ≤ 1 (based on CTCAE v5.0) except alopecia and fatigue.
- Female patients of childbearing potential should have a negative blood pregnancy test result within 48 h prior to the first dose of investigational drug.
Key exclusion criteria (12 listed)
- Known active central nervous system (CNS) involvement or history of the disease, or clinical signs of multiple myeloma meningeal/spinal meningeal involvement.
- Patients with solitary plasmacytoma; plasma cell leukemia (PCL) (active PCL or history of PCL); Waldenström's macroglobulinemia; POEMS syndrome or symptomatic amyloidosis.
- Prior active or history of malignancies other than MM, occurring within 5 years prior to the first dose of investigational drug, with the exception of radically treated local curable cancers.
- Uncontrolled or severe cardiovascular disorders.
- Any active infection within 14 days prior to the first dose of investigational drug.
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 |
|---|---|---|
| ICP-490Several dose groups of ICP-490 are planned for the dose exploration. | Drug | ICP-490, ICP-490 in combination with Dexamethasone |
| DexamethasoneOral Dexamethasone is administered on Days 1, 8, 15, and 22 of each 28-day cycle. | Drug | ICP-490 in combination with Dexamethasone |
Primary outcome
Phase I : Incidence, type, and severity of adverse events (AEs) as judged according to NCI-CTCAE V5.0
Time frame: Through study completion, an average of 3 years
AE refers to any adverse event occurring in subjects during clinical research period. The incidence and type of AEs will be evaluated and the severity will be judged according to National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version5.0.
Phase I : Incidence, type, and severity of dose-limiting toxicities (DLTs)
Time frame: Through study completion, an average of 3 years
The dose-limiting toxicity (DLT) assessed in the phase I dose exploration study is defined as AEs related to study treatment that meet the following criteria (according to the NCI CTCAE v5.0 criteria) and occur in Cycle 1.
Phase I : RP2Ds and/or MTDs
Time frame: Through study completion, an average of 3 years
Phase I is the dose exploration study of ICP-490 to preliminarily determine RP2Ds (probably more than one) and MTD (if applicable). MTD: The dose level corresponding to the dose group whose posterior probability of DLT incidence estimated by PAVA (pool adjacent violators algorithm) is closest to the target toxicity probability (25%).
Phase II : ORR (defined as sCR + CR + VGPR + PR) assessed according to IMWG criteria.
Time frame: Through study completion, an average of 3 years
Disease response will be assessed according to the 2016 IMWG response criteria.
14 secondary outcomes
Maximum concentration (Cmax)
Time frame: Through study completion, an average of 3 years
Time to maximum concentration (Tmax)
Time frame: Through study completion, an average of 3 years
Half-life (T1/2)
Time frame: Through study completion, an average of 3 years
Area under the concentration-time curve (AUC0-∞ and AUC0-t)
Time frame: Through study completion, an average of 3 years
Apparent clearance (CL/F)
Time frame: Through study completion, an average of 3 years
Apparent volume of distribution during terminal phase (Vz/F)
Time frame: Through study completion, an average of 3 years
Steady-state PK parameters
Time frame: Through study completion, an average of 3 years
The overall response rate (ORR) assessed according to the International Myeloma Working Group (IMWG) criteria (ORR, defined as stringent complete response (sCR) + complete response (CR) + very good partial response (VGPR) + partial response (PR))
Time frame: Through study completion, an average of 3 years
Phase I & IIa : Complete response rate (CRR, defined as sCR + CR) assessed according to IMWG criteria
Time frame: Through study completion, an average of 3 years
Phase I & IIa : Very good or better partial response rate assessed according to IMWG criteria (≥ VGPR rate, defined as VGPR + sCR + CR)
Time frame: Through study completion, an average of 3 years
Phase I & IIa : Time to response (TTR) assessed according to IMWG criteria
Time frame: Through study completion, an average of 3 years
Phase I & IIa : Duration of response (DOR) assessed according to IMWG criteria
Time frame: Through study completion, an average of 3 years
Phase I & IIa : Progression-free survival (PFS) assessed according to IMWG criteria
Time frame: Through study completion, an average of 3 years
Phase I & IIa : Overall survival (OS)
Time frame: Through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ICP-490 and Dexamethasone in people with Relapsed and/or Refractory Multiple Myeloma, run by Beijing InnoCare Pharma Tech 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 5 inclusion and 12 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 9 Apr 2024. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact April Huang (010-66609723, April.huang@innocarepharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I : Incidence, type, and severity of adverse events (AEs) as judged according to NCI-CTCAE V5.0 (time frame: Through study completion, an average of 3 years). The study lists 4 primary outcomes in all. 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 9 Apr 2024.