NCT05276310 A Study of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy
| NCT ID | NCT05276310 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | ImmuneOncia Therapeutics Inc. |
| Condition | Advanced Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 62 participants |
| Start Date | 2022-06-02 |
| Primary Completion | 2027-12-17 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 62 participants in total. It began in 2022-06-02 with a primary completion date of 2027-12-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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
Contact & Investigator
HEUNG TAE KIM, MD
STUDY DIRECTOR
ImmuneOncia Therapeutics Inc.
Frequently Asked Questions
Who can join the NCT05276310 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Advanced Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05276310 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05276310 currently recruiting?
Yes, NCT05276310 is actively recruiting participants. Contact the research team at sylee@immuneoncia.com for enrollment information.
Where is the NCT05276310 trial being conducted?
This trial is being conducted at Goyang-si, South Korea, Seoul, South Korea, Seoul, South Korea.
Who is sponsoring the NCT05276310 clinical trial?
NCT05276310 is sponsored by ImmuneOncia Therapeutics Inc.. The principal investigator is HEUNG TAE KIM, MD at ImmuneOncia Therapeutics Inc.. The trial plans to enroll 62 participants.
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