A Study of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy

NCT ID: NCT05276310

Last Updated: 2025-06-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-02
• Study Completion Date: 2029-08-30

Brief Summary

This is an Open-Label, Dose-Escalation and Expansion, Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Clinical Activity of IMC-002 in Patients with Advanced Cancer Failed to Standard Therapy

Detailed Description

The purpose of this study is to evaluate safety and tolerability and to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IMC-002.

Multiple-dose levels of IMC-002 will be tested in subjects with advanced cancer.

Conditions

Advanced Cancer

Study Design

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

Study Groups

IMC-002

IMC-002

Group Type: EXPERIMENTAL

IMC-002

Intervention Type: BIOLOGICAL

Part 1: Dose escalation IMC-002 5, 10, 20, and 30 mg/kg over 3 hours (±30 minutes) intravenous (IV) infusion every 2 weeks Part 2: Expansion cohort IMC-002 20 mg/kg over 3 hours (±30 minutes) IV infusion at the first cycle, if the first infusion is tolerated, then over 1 to 1.5 hours (±10 minutes) IV infusion at all following cycles every 3 weeks In hepatocellular (HCC) Cohort, Lenvatinib 8 mg once daily (body weight of \< 60 kg), or 12 mg once daily (body weight of ≥ 60 kg) In triple negative breast cancer (TNBC) Cohort, Paclitaxel 175 mg/m2 IV infusion on Day 1 of each cycle, or Gemcitabine 1,000 mg/m2 followed by Carboplatin AUC 2 IV infusion on Day 1 and Day 8 of each cycle In biliary tract cancer (BTC) Cohort, Lenvatinib 8 mg once daily (body weight of \< 60 kg), or 12 mg once daily (body weight of ≥ 60 kg) In B-cell lymphoma Cohort, Rituximab 375 mg/m2 IV infusion on Day 1 of each cycle

Interventions

IMC-002

Part 1: Dose escalation IMC-002 5, 10, 20, and 30 mg/kg over 3 hours (±30 minutes) intravenous (IV) infusion every 2 weeks Part 2: Expansion cohort IMC-002 20 mg/kg over 3 hours (±30 minutes) IV infusion at the first cycle, if the first infusion is tolerated, then over 1 to 1.5 hours (±10 minutes) IV infusion at all following cycles every 3 weeks In hepatocellular (HCC) Cohort, Lenvatinib 8 mg once daily (body weight of \< 60 kg), or 12 mg once daily (body weight of ≥ 60 kg) In triple negative breast cancer (TNBC) Cohort, Paclitaxel 175 mg/m2 IV infusion on Day 1 of each cycle, or Gemcitabine 1,000 mg/m2 followed by Carboplatin AUC 2 IV infusion on Day 1 and Day 8 of each cycle In biliary tract cancer (BTC) Cohort, Lenvatinib 8 mg once daily (body weight of \< 60 kg), or 12 mg once daily (body weight of ≥ 60 kg) In B-cell lymphoma Cohort, Rituximab 375 mg/m2 IV infusion on Day 1 of each cycle

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Signed ICF

2. Adult (19 years or older)

3. Diagnosis and prior therapies

3-1. Part 1: Histologically or cytologically proven metastatic or locally advanced solid tumors

3-2. Part 2, HCC Cohort:

1. Histologically or cytologically proven metastatic or locally advanced of hepatocellular carcinoma (excluding fibrolamellar, sarcomatoid or mixed cholangio-HCC tumors)

2. Received ≥1 prior systemic therapy; lenvatinib-naive and eligible for lenvatinib.

3. Child Pugh classification A

3-3. Part 2, TNBC Cohort:

1. Histologically or cytologically proven metastatic or locally advanced of triple negative breast cancer: negative of estrogen receptor (ER), progesterone receptor (PgR), and human epidermal growth factor receptor 2 (HER2)

2. Received ≥1 prior systemic regimen and eligible for paclitaxel or gemcitabine/carboplatin. Patients who have previously received the planned SOC in this study (paclitaxel or gemcitabine/carboplatin) cannot be enrolled. If at least 6 months have elapsed since the completion of a prior SOC (paclitaxel, gemcitabine, and/or carboplatin) and the patient showed a tumor response to that regimen, the same SOC can be used in this trial.

3. Bisphosphonate or denosumab for bone metastases is allowed if started before Cycle 1 Day 1. Prophylactic use of bisphosphonates or denosumab in patients without bone diseases is not permitted, except for the treatment of osteoporosis.

3-4. Part 2, BTC Cohort:

1. Histologically or cytologically proven metastatic or locally advanced of biliary tract cancer (gallbladder cancer, cholangiocarcinoma)

2. Received ≥1 prior systemic therapy; lenvatinib-naive and eligible for lenvatinib

3-5. Part 2, B-cell lymphoma Cohort:

1. Histologically or cytologically proven CD20+ mature B-cell lymphoma according to 2016 WHO classification including:

• diffuse large B-cell lymphoma (de novo or transformed)
• Mantle cell lymphoma
• Follicular lymphoma
• Marginal zone lymphoma (nodal, extranodal or mucosa associated)

2. Received ≥2 prior systemic therapies and eligible for rituximab treatment

• For all cancer type, neo-adjuvant and/or adjuvant chemotherapy is not regarded as chemotherapeutic regimen for metastatic or recurrent cancer unless recurrence within 6 months after the last dose of anti-cancer drugs as neo-adjuvant and/or adjuvant therapy.

4. Subject must have at least 1 measurable lesion by RECIST 1.1

5. Availability of tumor archival material or fresh biopsies

6. ECOG performance status 0 or 1 and life expectancy ≥3 months

7. Adequate hematologic function, hepatic function, and renal function

8. Prior RT permitted if measurable disease exists outside the RT field or if disease progressed post-RT. RT must be completed ≥4 weeks before Cycle 1 Day 1

9. Agree to use effective contraception

10. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria

1. Treatment with nonpermitted drugs

2. Prior treatment with a CD47 or SIRPα targeting agent

3. Concurrent anticancer treatments

4. Major surgery or significant traumatic injury prior to Screening or planned major surgery during the study period

5. Previous malignant disease other than the target malignancy for this study

6. Active infection requiring systemic therapy before Day 1

7. Any active autoimmune disease, or history of autoimmune disease

8. Any psychiatric or cognitive condition

9. Known severe hypersensitivity reaction

10. Pregnant or lactating

11. Currently enrolled in another clinical study

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ImmuneOncia Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

HEUNG TAE KIM, MD

Role: STUDY_DIRECTOR

ImmuneOncia Therapeutics Inc.

Locations

National Cancer Center

Ilsan, , South Korea

Site Status: RECRUITING

Asan Medical Center, Republic of Korea

Seoul, , South Korea

Site Status: RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

SUNG YOUNG LEE

Role: CONTACT

sylee@immuneoncia.com

+82 2 6283 5068

Facility Contacts

Keun Seok Lee, Chief Director of Affiliated Hospital

Role: primary

kslee@ncc.re.kr

+821020872291

Ho Yeong Lim, MD

Role: primary

Other Identifiers

IMC-002-K102

Identifier Type: -

Identifier Source: org_study_id