A Study of IMC-002 in Patients With Advanced Cancer Failed to Standard Therapy
Recruiting
Phase 1Interventional Study
Advanced Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
19 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
62 (estimated)
Sponsor
ImmuneOncia Therapeutics Inc. · Industry
Who this trial is looking for
This trial is looking for adults with advanced cancer that has not responded to standard treatments. Participants will receive a new treatment called IMC-002 and will be monitored for safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I am at least 19 years old.
I have been diagnosed with advanced cancer.
I have had at least one prior treatment for my cancer.
I have a measurable tumor.
I can provide tumor tissue samples.
I have an ECOG performance status of 0 or 1.
I expect to live for at least 3 more months.
I agree to use effective contraception.
You may not be able to join if
I am currently taking non-permitted drugs.
I have received a treatment targeting CD47 or SIRPα.
I am undergoing other cancer treatments.
I have had major surgery recently or plan to have it soon.
I have a history of a different type of cancer.
I have an active infection needing treatment.
I currently have an autoimmune disease.
I am pregnant or breastfeeding.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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 advance…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.