Testing IMC-002 in patients with advanced cancer who have not responded to standard treatments
Official title: 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
Run by ImmuneOncia Therapeutics Inc. · NCT05276310 · Data updated 2026-11-12
This study is testing a new treatment called IMC-002 in patients with advanced cancer who haven't had success with regular therapies to see if it can help them.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 86 (estimated) |
| Sponsor | ImmuneOncia Therapeutics Inc. Industry-sponsored |
| Drugs / interventions | denosumab, rituximab, lenvatinib, chemotherapy |
| Locations | 3 sites (Goyang-si and 2 other locations) |
| Status | Recruiting |
| Started | June 2, 2022 |
| Main results expected | December 30, 2027 |
| Study ends | August 31, 2030 |
| Registry record updated | September 25, 2026 |
| Trial ID | NCT05276310 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with histologically or cytologically proven metastatic or locally advanced solid tumors who have at least one measurable lesion.
✕Probably not a fit
Patients who have previously received treatment with CD47 or SIRPα targeting agents or those currently undergoing other anticancer treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open-label, dose-escalation Phase I study aims to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of IMC-002 in patients with advanced cancer who have failed standard therapy. The study will involve multiple dose levels of IMC-002 to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D). Participants will be monitored for their response to the treatment and any side effects experienced during the trial.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced cancer who have exhausted standard treatment options.
How similar studies have gone: Other studies targeting CD47 and SIRPα have shown promise, indicating potential for success with this approach.
Who can join: the full rules
Show full inclusion / exclusion 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, PDAC Cohort:
1. Histologically or cytologically proven metastatic or locally advanced of pancreatic ductal adenocarcinoma
2. Must have received one or two prior anti-cancer systemic regimen and adequate for administration of lenvatinib.
3-6. 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
Where it's running
-
Samsung Medical Center
Seoul, South Korea Recruiting -
National Cancer Center
Goyang-si, South Korea Active not recruiting -
Asan Medical Center, Republic of Korea
Seoul, South Korea Completed
Study contacts
- Study coordinator: Jihee Kwon
- Email: jhkwon@immuneoncia.com
- Phone: +82 2 6283 5064
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.