Evaluating ICP-490 for patients with relapsed multiple myeloma

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 study is testing a new treatment called ICP-490, combined with dexamethasone, to see if it can help people with relapsed multiple myeloma who haven't had success with other therapies.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. (Industry-sponsored)
• Locations: 6 sites (Beijing, Beijing and 5 other locations)
• Trial ID: NCT05719701 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multi-center, non-randomized, open-label study designed to assess the safety, tolerability, and efficacy of ICP-490 in patients suffering from relapsed and/or refractory multiple myeloma. The study will involve administering ICP-490 alongside dexamethasone to eligible participants, who will be monitored for treatment outcomes and side effects. The trial aims to gather data on how well this treatment works in this patient population, particularly focusing on those who have not responded to previous therapies.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have been diagnosed with relapsed and/or refractory multiple myeloma and have measurable disease.

Not a fit: Patients with active central nervous system involvement or those with certain other hematological malignancies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with relapsed and/or refractory multiple myeloma.

How similar studies have performed: While this approach is being evaluated in this specific context, similar studies have shown promise in targeting relapsed multiple myeloma with novel therapies.

Eligibility criteria

Inclusion Criteria:

1. Aged ≥ 18 years old.
2. 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.
3. Patients must have adequate organ function. Expected survival time ≥ 6 months.
4. 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.

Exclusion Criteria:

1. Known active central nervous system (CNS) involvement or history of the disease, or clinical signs of multiple myeloma meningeal/spinal meningeal involvement.
2. Patients with solitary plasmacytoma; plasma cell leukemia (PCL) (active PCL or history of PCL); Waldenström's macroglobulinemia; POEMS syndrome or symptomatic amyloidosis.
3. 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.
4. Uncontrolled or severe cardiovascular disorders.
5. Any active infection within 14 days prior to the first dose of investigational drug.
6. Patients with diseases restricted from participation as described in the protocol
7. 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.
8. 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.
9. 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.
10. 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.
11. 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).

Where this trial is running

Beijing, Beijing and 5 other locations

• Peking University People's Hospital — Beijing, Beijing, China (Recruiting)
• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (Not_yet_recruiting)
• Henan Cancer Hosptital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• Renji Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai, China (Not_yet_recruiting)
• The First Affiliated Hospital，Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: April Huang

Conditions Relapsed and/or Refractory Multiple Myeloma