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NCT Number: NCT05276310

A Study 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

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Key information

Conditions

Advanced Cancer

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Cancer Center, Goyang-si, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • ECOG performance status 0 or 1 and life expectancy ≥3 months
  • Adequate hematologic function, hepatic function, and renal function
  • 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
  • Agree to use effective contraception
  • Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion criteria

  • 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

Treatment and study plan

IMC-002

Biological

Part 1: Dose escalation IMC-002 5, 10, 20, and 30 mg/kg over 3 hours (±30 minutes) intravenous (IV) infusion every 2 weeks Part 2: Expansion cohort IMC-002 20 mg/kg over 3 hours (±30 minutes) IV infusion at the first cycle, if the first infusion is tolerated, then over 1 to 1.5 hours (±10 minutes) IV infusion at all following cycles every 3 weeks In hepatocellular (HCC) Cohort, Lenvatinib 8 mg once daily (body weight of < 60 kg), or 12 mg once daily (body weight of ≥ 60 kg) In triple negative breast cancer (TNBC) Cohort, Paclitaxel 175 mg/m2 IV infusion on Day 1 of each cycle, or Gemcitabine 1,000 mg/m2 followed by Carboplatin AUC 2 IV infusion on Day 1 and Day 8 of each cycle In biliary tract cancer (BTC) Cohort, Lenvatinib 8 mg once daily (body weight of < 60 kg), or 12 mg once daily (body weight of ≥ 60 kg) In B-cell lymphoma Cohort, Rituximab 375 mg/m2 IV infusion on Day 1 of each cycle

Primary outcomes

  1. Incidence of Dose-Limiting Toxicities (DLTs)

    Time frame: 21 days

    To determine maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IMC-002

  2. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Time frame: through study completion, an average of 1 year

    • clinically significant changes in physical examination, vital signs, ECG parameters, clinical laboratory tests, AEs
    • Immunogenicity: anti-IMC-002 antibody

Secondary outcomes

  1. Pharmacokinetics Endpoint : Cmax

    Time frame: through study completion, an average of 1 year

    maximum observed serum concentration (Cmax) of IMC-002

  2. Pharmacokinetics Endpoint : Ctrough

    Time frame: through study completion, an average of 1 year

    minimum observed serum concentration immediately before dosing (Ctrough) of IMC-002

  3. Pharmacokinetics Endpoint : Tmax

    Time frame: through study completion, an average of 1 year

    time of the maximum observed serum concentration (Tmax) of IMC-002

  4. Pharmacokinetics Endpoint : AUC

    Time frame: through study completion, an average of 1 year

    Area Under the Serum Concentration-Time Curve (AUC) of IMC-002

  5. Pharmacokinetics Endpoint : CL

    Time frame: through study completion, an average of 1 year

    total body clearance (CL) of IMC-002

  6. Pharmacokinetics Endpoint : t½

    Time frame: through study completion, an average of 1 year

    terminal half-life (t½) of IMC-002

  7. Efficacy endpoints based on tumor assessment (Part2) : BOR

    Time frame: Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.

    best overall response (BOR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by RECIST 1.1 (for solid tumors) or Lugano criteria (for B-cell lymphoma).

  8. Efficacy endpoints based on tumor assessment (Part2) : ORR

    Time frame: Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.

    objective response rate (ORR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by RECIST 1.1 (for solid tumors) or Lugano criteria (for B-cell lymphoma).

  9. Efficacy endpoints based on tumor assessment (Part2) : DCR

    Time frame: Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.

    disease control rate (DCR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by RECIST 1.1 (for solid tumors) or Lugano criteria (for B-cell lymphoma).

  10. Efficacy endpoints based on tumor assessment (Part2) : DOR

    Time frame: Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.

    duration of response (DOR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by RECIST 1.1 (for solid tumors) or Lugano criteria (for B-cell lymphoma).

  11. Efficacy endpoints based on tumor assessment (Part2) : TTP

    Time frame: Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.

    time-to-progression (TTP) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by RECIST 1.1 (for solid tumors) or Lugano criteria (for B-cell lymphoma).

  12. Efficacy endpoints based on tumor assessment (Part2) : PFS

    Time frame: Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.

    progression-free survival (PFS) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by RECIST 1.1 (for solid tumors) or Lugano criteria (for B-cell lymphoma).

  13. Efficacy endpoints based on tumor assessment (Part2) : iBOR

    Time frame: Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.

    Immune best overall response(iBOR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by iRECIST(Solid tumor) or Lugano criteria with LYRIC modification(B-cell Lymphoma).

  14. Efficacy endpoints based on tumor assessment (Part2) : iORR

    Time frame: Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.

    Immune objective response rate(iORR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by iRECIST(Solid tumor) or Lugano criteria with LYRIC modification(B-cell Lymphoma).

  15. Efficacy endpoints based on tumor assessment (Part2) : iDCR

    Time frame: Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.

    Immune disease control rate(iDCR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by iRECIST(Solid tumor) or Lugano criteria with LYRIC modification(B-cell Lymphoma).

  16. Efficacy endpoints based on tumor assessment (Part2) : iDOR

    Time frame: Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.

    Immune duration of response(iDOR) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by iRECIST(Solid tumor) or Lugano criteria with LYRIC modification(B-cell Lymphoma).

  17. Efficacy endpoints based on tumor assessment (Part2) : iTTP

    Time frame: Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.

    Immune time-to-progression(iTTP) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by iRECIST(Solid tumor) or Lugano criteria with LYRIC modification(B-cell Lymphoma).

  18. Efficacy endpoints based on tumor assessment (Part2) : iPFS

    Time frame: Tumor assessments will be conducted every 2 cycles by contrast-enhanced CT (solid tumor), and every 3 cycles by PET-CT/CT with contrast (B-cell lymphoma), within 5 days prior to Day 1 of the next cycle, through study completion, an average of 1 year.

    Immune progression-free survival(iPFS) To evaluate efficacy of IMC-002 in combination with standard of care (SOC) anti-cancer therapy, as assessed by iRECIST(Solid tumor) or Lugano criteria with LYRIC modification(B-cell Lymphoma).

  19. Efficacy endpoints based on tumor assessment (Part2) : overall survival (OS)

    Time frame: through study completion, an average of 1 year

    overall survival (OS)

Study contacts

Contact information is provided by the study sponsor or research team.

SUNG YOUNG LEE

CONTACT

[email protected]

+82 2 6283 5096

Sponsors and collaborators

Lead sponsor

ImmuneOncia Therapeutics Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2027
Study completion
2029
First posted
Mar 11, 2022
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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