Evaluate the Safety, Tolerability, and Efficacy of ICP-490 in Patients With Relapsed and/or Refractory Multiple Myeloma

NCT05719701 | Recruiting Phase 1

• 1 other identifier: ICP-CL-01101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Relapsed and/or Refractory Multiple Myeloma

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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%).

  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.

  Through study completion, an average of 3 years

Secondary Outcomes (14)

• Maximum concentration (Cmax)

  Through study completion, an average of 3 years

• Time to maximum concentration (Tmax)

  Through study completion, an average of 3 years

• Half-life (T1/2)

  Through study completion, an average of 3 years

• Area under the concentration-time curve (AUC0-∞ and AUC0-t)

  Through study completion, an average of 3 years

• Apparent clearance (CL/F)

  Through study completion, an average of 3 years

Study Arms (2)

ICP-490

EXPERIMENTAL

Drug: ICP-490

ICP-490 in combination with Dexamethasone

EXPERIMENTAL

Drug: ICP-490; Drug: Dexamethasone

Interventions

ICP-490 DRUG

Several dose groups of ICP-490 are planned for the dose exploration.

ICP-490; ICP-490 in combination with Dexamethasone

Dexamethasone DRUG

Oral Dexamethasone is administered on Days 1, 8, 15, and 22 of each 28-day cycle.

ICP-490 in combination with Dexamethasone

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• Beijing InnoCare Pharma Tech Co., Ltd.: lead

Study Sites (6)

Peking University People's Hospital

Beijing, Beijing Municipality, China

RECRUITING

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510120, 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 Municipality, China

NOT YET RECRUITING

The First Affiliated Hospital，Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

NOT YET RECRUITING

MeSH Terms

Interventions

Dexamethasone

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Central Study Contacts

April Huang

CONTACT

010-66609723; April.huang@innocarepharma.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: February 9, 2023
• Study Start: March 29, 2023
• Primary Completion: July 30, 2025
• Study Completion: December 30, 2025
• Last Updated: April 9, 2024

Record last verified: 2024-03

Locations

CN (6)