A Study of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy

Phase 1

Recruiting

• Conditions: Advanced Cancer
• Interventions: Biological: IMC-002

• Registration Number: NCT05276310
• Lead Sponsor: ImmuneOncia Therapeutics Inc.

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2022-02-22
• Study First Submitted QC: 2022-03-02
• Study First Posted: 2022-03-11
• Study Start: 2022-06-02
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-24
• Last Update Posted: 2025-06-27
• Primary Completion: 2027-12-17
• Study Completion: 2029-08-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMC-002	IMC-002	IMC-002

Primary Outcome Measures

Name	Time	Method
Incidence of Dose-Limiting Toxicities (DLTs)	21 days	To determine maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) of IMC-002
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]	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 Outcome Measures

Name	Time	Method
Pharmacokinetics Endpoint : t½	through study completion, an average of 1 year	terminal half-life (t½) of IMC-002
Efficacy endpoints based on tumor assessment (Part2) : overall survival (OS)	through study completion, an average of 1 year	overall survival (OS)
Pharmacokinetics Endpoint : Cmax	through study completion, an average of 1 year	maximum observed serum concentration (Cmax) of IMC-002
Pharmacokinetics Endpoint : Ctrough	through study completion, an average of 1 year	minimum observed serum concentration immediately before dosing (Ctrough) of IMC-002
Pharmacokinetics Endpoint : Tmax	through study completion, an average of 1 year	time of the maximum observed serum concentration (Tmax) of IMC-002
Pharmacokinetics Endpoint : AUC	through study completion, an average of 1 year	Area Under the Serum Concentration-Time Curve (AUC) of IMC-002
Pharmacokinetics Endpoint : CL	through study completion, an average of 1 year	total body clearance (CL) of IMC-002
Efficacy endpoints based on tumor assessment (Part2) : BOR	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).
Efficacy endpoints based on tumor assessment (Part2) : ORR	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).
Efficacy endpoints based on tumor assessment (Part2) : DCR	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).
Efficacy endpoints based on tumor assessment (Part2) : DOR	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).
Efficacy endpoints based on tumor assessment (Part2) : TTP	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).
Efficacy endpoints based on tumor assessment (Part2) : PFS	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).
Efficacy endpoints based on tumor assessment (Part2) : iBOR	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).
Efficacy endpoints based on tumor assessment (Part2) : iORR	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).
Efficacy endpoints based on tumor assessment (Part2) : iDCR	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).
Efficacy endpoints based on tumor assessment (Part2) : iDOR	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).
Efficacy endpoints based on tumor assessment (Part2) : iTTP	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).
Efficacy endpoints based on tumor assessment (Part2) : iPFS	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).

Trial Locations

Locations (3)

National Cancer Center; 🇰🇷 Ilsan, Korea, Republic of

Asan Medical Center, Republic of Korea; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of