A Study of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy
Recruiting now · Phase 1
Conditions studied: Advanced Cancer
In brief
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
Key facts
- Study ID
- NCT05276310
- Run by
- ImmuneOncia Therapeutics Inc.
- People needed
- 62
- Starts
- 2022-06-02
- Expected to finish
- 2029-08-30
- Last updated by the study team
- 2026-04-24
Who can join
Age: 19 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Signed ICF
- Adult (19 years or older)
- Diagnosis and prior therapies
- 3-1. Part 1: Histologically or cytologically proven metastatic or locally advanced solid tumors
- 3-2. Part 2, HCC Cohort:
- Histologically or cytologically proven metastatic or locally advanced of hepatocellular carcinoma (excluding fibrolamellar, sarcomatoid or mixed cholangio-HCC tumors)
- Received ≥1 prior systemic therapy; lenvatinib-naive and eligible for lenvatinib.
- Child Pugh classification A
- 3-3. Part 2, TNBC Cohort:
- 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)
- 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.
- 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:
- Histologically or cytologically proven metastatic or locally advanced of biliary tract cancer (gallbladder cancer, cholangiocarcinoma)
- Received ≥1 prior systemic therapy; lenvatinib-naive and eligible for lenvatinib
- 3-5. Part 2, B-cell lymphoma Cohort:
- 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)
- 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.
- Subject must have at least 1 measurable lesion by RECIST 1.1
- Availability of tumor archival material or fresh biopsies
You may not qualify if…
- Treatment with nonpermitted drugs
- Prior treatment with a CD47 or SIRPα targeting agent
- Concurrent anticancer treatments
- Major surgery or significant traumatic injury prior to Screening or planned major surgery during the study period
- Previous malignant disease other than the target malignancy for this study
- Active infection requiring systemic therapy before Day 1
- Any active autoimmune disease, or history of autoimmune disease
- Any psychiatric or cognitive condition
- Known severe hypersensitivity reaction
- Pregnant or lactating
- Currently enrolled in another clinical study
Where it is running
- Samsung Medical Center — Seoul, South Korea (enrolling)
- National Cancer Center — Goyang-si, South Korea
- Asan Medical Center, Republic of Korea — Seoul, South Korea
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.