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

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

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

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.

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