Clinical trial NCT05276310: A Study of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Cancer
Keywords: IMC-002
Phase I
CD47
SIRPα
Lead sponsor: ImmuneOncia Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2022-03-11
Enrollment: 62
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Part 1: Dose Escalation Part 2: Expansion cohort
Primary purpose: TREATMENT

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.

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:

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   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:

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   1. Histologically or cytologically proven CD20+ mature B-cell lymphoma according to 2016 WHO classification including:

      ① diffuse large B-cell lymphoma (de novo or transformed)

      ② Mantle cell lymphoma

      ③ Follicular lymphoma

      ④ Marginal zone lymphoma (nodal, extranodal or mucosa associated)
   2. Received ≥2 prior systemic therapies and eligible for rituximab treatment \*\*\* 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

Primary outcomes:
measure: Incidence of Dose-Limiting Toxicities (DLTs)
timeFrame: 21 days
measure: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Pharmacokinetics Endpoint : Cmax
timeFrame: through study completion, an average of 1 year
measure: Pharmacokinetics Endpoint : Ctrough
timeFrame: through study completion, an average of 1 year
measure: Pharmacokinetics Endpoint : Tmax
timeFrame: through study completion, an average of 1 year
measure: Pharmacokinetics Endpoint : AUC
timeFrame: through study completion, an average of 1 year
measure: Pharmacokinetics Endpoint : CL
timeFrame: through study completion, an average of 1 year
measure: Pharmacokinetics Endpoint : t½
timeFrame: through study completion, an average of 1 year
measure: Efficacy endpoints based on tumor assessment (Part2) : BOR
timeFrame: 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.
measure: Efficacy endpoints based on tumor assessment (Part2) : ORR
timeFrame: 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.
measure: Efficacy endpoints based on tumor assessment (Part2) : DCR
timeFrame: 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.
measure: Efficacy endpoints based on tumor assessment (Part2) : DOR
timeFrame: 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.
measure: Efficacy endpoints based on tumor assessment (Part2) : TTP
timeFrame: 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.
measure: Efficacy endpoints based on tumor assessment (Part2) : PFS
timeFrame: 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.
measure: Efficacy endpoints based on tumor assessment (Part2) : iBOR
timeFrame: 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.
measure: Efficacy endpoints based on tumor assessment (Part2) : iORR
timeFrame: 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.
measure: Efficacy endpoints based on tumor assessment (Part2) : iDCR
timeFrame: 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.
measure: Efficacy endpoints based on tumor assessment (Part2) : iDOR
timeFrame: 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.
measure: Efficacy endpoints based on tumor assessment (Part2) : iTTP
timeFrame: 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.
measure: Efficacy endpoints based on tumor assessment (Part2) : iPFS
timeFrame: 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.
measure: Efficacy endpoints based on tumor assessment (Part2) : overall survival (OS)
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Ilsan
country: Korea, Republic of
facility: National Cancer Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, Republic of Korea
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: ImmuneOncia Therapeutics Inc.
name: HEUNG TAE KIM, MD
role: STUDY_DIRECTOR
References: