Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 19 and up

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.

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Quick facts

PhasePhase 1
Study typeInterventional
Ages19 Years and up
SexAll
Enrollment86 (estimated)
SponsorImmuneOncia Therapeutics Inc.
Industry-sponsored
Drugs / interventionsdenosumab, rituximab, lenvatinib, chemotherapy
Locations3 sites (Goyang-si and 2 other locations)
StatusRecruiting
StartedJune 2, 2022
Main results expectedDecember 30, 2027
Study endsAugust 31, 2030
Registry record updatedSeptember 25, 2026
Trial IDNCT05276310 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.