HM16390 for Cancer

Recruiting at 2 trial locations

Overseen By Young Su (Bobby) Noh

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Hanmi Pharmaceutical Company Limited

Must not be taking: IL-2, IL-7, IL-15 agents

Disqualifiers: CNS metastases, Autoimmune disease, Infections, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

215 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of HM16390, as a single agent to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced or metastatic solid tumors. Dose-Escalation Part is planned to establish the MTD or RDs for the randomized Dose-Ranging Part. Based on the results of the Dose-Escalation Part, additional eligible subjects will be randomized 1:1 into at each dose level. After a comprehensive review of available data from both Dose-Escalation Part and Dose-Ranging Part, the potential RP2D to be tested in the Dose-Expansion Part is determined. Dose-Expansion Part is designed to assess the potential efficacy of HM16390 as a single agent when administered at the potential RP2D to subjects in indication-specific expansion cohorts.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How is the drug HM16390 different from other cancer treatments?

The research does not provide specific information about HM16390, so its unique features compared to other cancer treatments are not clear from the available data. ^{1 2 3 4 5}

Eligibility Criteria

This trial is for people with advanced or metastatic solid tumors. Participants should be adults who have tried other treatments without success, and their bodies must be able to handle the study procedures. Specific details about what makes someone eligible or not are not provided here.

Inclusion Criteria

My advanced cancer did not respond or I couldn't tolerate standard treatment.

My blood counts are within a healthy range.

My cancer can be measured or seen on scans.

Exclusion Criteria

I have had severe side effects from previous immunotherapy.

Has ongoing or suspected autoimmune disease

I do not have any active, significant infections or HIV/AIDS.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose-Escalation

Establish the maximum tolerated dose (MTD) or recommended dose (RD) for the randomized Dose-Ranging Part

21 days per cycle

Dose-Expansion

Assess the potential efficacy of HM16390 as a single agent at the potential RP2D in indication-specific expansion cohorts

Up to 2-3 years

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days after the last treatment

Treatment Details

Interventions

• HM16390

Trial Overview The trial is testing HM16390, a new potential cancer treatment. It starts by finding the highest dose patients can take without serious side effects (MTD), then tests different doses to find one that's effective but still safe (RP2D). Finally, it looks at how well this dose works in specific types of cancer.

Participant Groups

Group I: HM16390 Monotherapy Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Hanmi Pharmaceutical Company Limited

Lead Sponsor

Trials

196

Recruited

62,100+

Young Choi

Hanmi Pharmaceutical Company Limited

Chief Medical Officer since 2023

PhD in Pharmacology from Yonsei University

Jae-Hyun Park

Hanmi Pharmaceutical Company Limited

Chief Executive Officer since 2024

MD from Seoul National University

Findings from Research

A 38-year-old woman with previously good health was diagnosed with metastatic clear cell renal carcinoma (RCC) after presenting with severe symptoms including fatigue, weight loss, and flank pain, alongside significant lab findings such as hypercalcemia and anemia.

The diagnosis revealed poor-risk metastatic RCC with sarcomatoid features, leading to the initiation of first-line systemic treatment, highlighting the aggressive nature of this cancer type.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metastatic Renal Cell Carcinoma With Sarcomatoid Features. Mateos-Soria, A., Castro-Alonso, FJ., Senser, Y., et al.[2022]

The introduction of targeted therapies for metastatic renal cell carcinoma (mRCC) in Estonia significantly improved patient outcomes, with a median survival of 19.8 months for those receiving targeted treatments compared to just 7.6 months for those treated only with interferon alpha-2A.

Patients who received targeted therapies had nearly four times lower risk of dying compared to those who only received interferon, highlighting the efficacy of these newer treatments in extending survival for mRCC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in therapy and survival of metastatic renal cell carcinoma in Estonia. Jürgens, H., Ojamaa, K., Pokker, H., et al.[2020]

Combination therapies targeting immune checkpoints and vascular endothelial growth factor receptors have significantly improved outcomes for patients with metastatic renal cell carcinoma, leading to durable disease control and prolonged overall survival.

The evolving understanding of the disease at genomic and immunologic levels has resulted in marked improvements in survival rates, making combination approaches the standard of care for first-line treatment, although careful study design is essential for accurate outcome estimation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Selection in First-line Metastatic Renal Cell Carcinoma-The Contemporary Treatment Paradigm in the Age of Combination Therapy: A Review. Navani, V., Heng, DYC.[2022]

Nivolumab, an anti-PD-1 monoclonal antibody, has significantly improved treatment outcomes for advanced cancers like lung cancer, renal cancer, and melanoma, promoting long-lasting anti-tumor immunity.

Despite its effectiveness, nivolumab monotherapy fails in 60-70% of patients, but combining it with other therapies, such as chemotherapy or CTLA-4 inhibitors, has been shown to enhance its efficacy and overcome resistance in cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination therapy with nivolumab (anti-PD-1 monoclonal antibody): A new era in tumor immunotherapy. Abedi Kiasari, B., Abbasi, A., Ghasemi Darestani, N., et al.[2022]

Nivolumab (Opdivo®) has been established as an effective second-line treatment for metastatic renal cell carcinoma (mRCC), showing improved overall survival (26 months vs. 19.7 months) and response rates compared to Everolimus, based on the CheckMate 025 trial with 1,080 participants.

The combination of Nivolumab and Ipilimumab has demonstrated a significantly higher objective response rate (42% vs. 27%) and better overall survival in intermediate and high-risk patients compared to Sunitinib, while also improving quality of life, despite an increase in immune-related adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Immunotherapy for renal cell carcinoma - current status]. Grimm, MO., Foller, S.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Metastatic Renal Cell Carcinoma With Sarcomatoid Features. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Changes in therapy and survival of metastatic renal cell carcinoma in Estonia. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Treatment Selection in First-line Metastatic Renal Cell Carcinoma-The Contemporary Treatment Paradigm in the Age of Combination Therapy: A Review. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Combination therapy with nivolumab (anti-PD-1 monoclonal antibody): A new era in tumor immunotherapy. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

[Immunotherapy for renal cell carcinoma - current status]. [2019]