IMC-002 for Cancer

No longer recruiting at 5 trial locations
JH
ES
Overseen ByEunJeong Seo
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: ImmuneOncia Therapeutics Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called IMC-002 to determine its safety and effectiveness for people with certain advanced cancers. It targets individuals with solid tumors that have spread or cannot be surgically removed, as well as those with lymphomas unresponsive to previous treatments. Participants must have a confirmed diagnosis of these conditions and no available treatments that improve survival. The trial aims to discover how the body processes the drug and its effects on the cancer. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its function in people.

Will I have to stop taking my current medications?

The trial protocol does not specify if you must stop taking your current medications, but you cannot take certain drugs within 28 days before starting the study treatment.

Is there any evidence suggesting that IMC-002 is likely to be safe for humans?

Research has shown that IMC-002 was safe in earlier studies. Patients who received IMC-002 through an IV every two weeks, at doses up to 30 mg/kg, tolerated it well, with no major safety issues at these doses. Additionally, tests on animals at even higher doses—up to 100 mg/kg—showed good tolerance without any blood-related problems. This suggests that IMC-002 is generally safe at the tested doses. As this trial marks the first time IMC-002 is being tested in humans, researchers are closely monitoring safety.12345

Why do researchers think this study treatment might be promising?

IMC-002 is unique because it targets tumors and lymphomas in a different way than most current treatments. While many existing therapies focus on destroying cancer cells directly, IMC-002 is designed to modulate the immune system, potentially enhancing its ability to recognize and attack cancer cells. Researchers are excited about this treatment because it could offer a more targeted approach, potentially leading to better outcomes with fewer side effects compared to traditional chemotherapy and radiation. This innovative mechanism makes IMC-002 a promising option for patients with metastatic or locally advanced solid tumors and relapsed or refractory lymphomas.

What evidence suggests that IMC-002 might be an effective treatment for solid tumors and lymphomas?

Research has shown that IMC-002 holds promise for treating advanced solid tumors and certain lymphomas. Early data from ongoing studies suggest that IMC-002, the investigational treatment in this trial, could be effective. In one study, patients with liver cancer (HCC) who had limited treatment options responded well when IMC-002 was combined with lenvatinib. Researchers observed no severe side effects at various doses, indicating that the treatment is generally well-tolerated. While more research is needed, early results offer hope for those with hard-to-treat cancers.26789

Who Is on the Research Team?

HT

HEUNG TAE KIM

Principal Investigator

ImmuneOncia Therapeutics Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Signed informed consent form (ICF)
Histologically or cytologically proven metastatic or locally advanced solid tumors and relapsed or refractory lymphomas, for which no standard therapy known to prolong survival exists or have relapsed/refractory/PD following the last line of treatment
Solid tumors must be measurable with at least 1 unidimensional measurable lesion by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Lymphomas must have at least 1 measurable lesion according to the Lugano criteria with the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) modification
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of IMC-002 to assess safety and tolerability

Expansion Cohorts

Participants receive IMC-002 at the recommended Phase 2 dose to further evaluate safety

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • IMC-002
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: IMC-002Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

ImmuneOncia Therapeutics Inc.

Lead Sponsor

Trials
5
Recruited
130+

Citations

1035P Phase I dose escalation study of IMC-002, a novel ...Here we present preliminary safety, pharmacokinetics (PK), and efficacy data from ongoing phase 1 study of IMC-002 in patients with advanced solid tumors who ...
Phase 1b dose extension study of a next-generation anti- ...Results: A total of 13 pts with refractory HCC received IMC-002 in combination with Lenvatinib. Most patients had received prior anti-PD-(L)1 ...
NCT05276310 | A Study of IMC-002 in Patients With ...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) ...
ImmuneOncia Announces Interim Results from Phase 1b ...The IMC-002 and lenvatinib combination shows strong potential as a second-line treatment option for HCC patients with limited alternatives.
A Study of IMC-002 in Patients With Advanced Cancer ...... IMC-002 at doses of 5, 10, 20, or 30 mg/kg every 2 weeks (Q2W). The clinical data showed no dose-limiting toxicities (DLT). 92% of treatment-related adverse ...
Updated safety, efficacy, pharmacokinetics, and ...Conclusions: IMC-002 has an excellent safety profile when administered intravenously at a dose of up to 30 mg/kg every 2 weeks intravenously ...
Outstanding safety and efficacy data of IMC002, an ...IMC002 showed a favorable safety profile, encouraging anti-tumor activities with observed pCR and persistent expansion in the tumor tissue at the low dosage ...
Development of IMC-002, a next-generation anti-CD47 mAb ...Furthermore, in non-human primates, IMC-002 was well-tolerated, with no hematological toxicity observed at doses up to 100 mg/kg, and exhibited ...
A Study of IMC-002 in Subjects With Metastatic or Locally ...This is the first-in-human, Phase I, open-label, multiple-ascending dose study to investigate the safety, tolerability, PK, PharmDyn, and clinical activity of ...
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