HM16390 for Cancer

Recruiting at 8 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

292 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HM16390 for individuals with advanced or widespread solid tumors that have not responded to standard treatments. Researchers aim to assess the safety and effectiveness of HM16390 by experimenting with different doses to identify the optimal one. Individuals with a confirmed diagnosis of an advanced or metastatic solid tumor who have not found success with other treatments might be suitable candidates for this study. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that HM16390 is likely to be safe for humans?

Research has shown that HM16390 has been safe in animal studies, including tests on rodents and monkeys. These studies found that HM16390, a new long-lasting protein that can boost the immune system, is well-tolerated. The treatment aims to minimize side effects by carefully managing its interaction with immune cells.

Although direct data from human trials is not yet available, this early animal research suggests that HM16390 could be safe for humans. This marks the first time HM16390 is being tested in humans, with the primary goal of assessing its safety for people. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

HM16390 is unique because it offers a potential new approach for treating cancer by acting as a monotherapy. While most cancer treatments focus on targeting and destroying cancer cells through chemotherapy or radiation, HM16390 is designed to work differently, potentially offering a more targeted and less invasive option. Researchers are excited about its novel mechanism of action, which may provide benefits such as fewer side effects and improved effectiveness compared to traditional treatments. This innovative approach could lead to a significant advancement in cancer therapy, offering new hope for patients.

What evidence suggests that HM16390 might be an effective treatment for cancer?

Research has shown that HM16390, administered as monotherapy in this trial, could be a promising cancer treatment, particularly based on animal studies. In mice, the treatment completely eliminated tumors in up to 100% of cases with the right dosage. This outcome is promising because it outperformed an existing treatment, aldesleukin, which only achieved complete tumor disappearance in 22% of similar tests. HM16390 is a long-lasting version of a current drug that targets cancer cells more effectively. Although human studies provide limited information, these early results suggest that HM16390 could be a strong option for treating advanced or spreading solid tumors. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: HM16390 + pembrolizumab Experimental Treatment 2 Interventions

HM16390 in combination with pembrolizumab

Group II: HM16390 Experimental Treatment 1 Intervention

HM16390 Monotherapy

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

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. jitc.bmj.com jitc.bmj.com/content/13/Suppl_2/A153

137 Identifying predictive biomarkers for HM16390, a novel ... This study aimed to identify transcriptomic biomarkers predictive of therapeutic response to HM16390 in cancer patients, using comprehensive ...

2. cancer.gov cancer.gov/clinicaltrials/NCI-2025-00728

Dose Escalation and Expansion Study of HM16390 in ... 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 ...

3. aacrjournals.org aacrjournals.org/cancerres/article/83/7_Supplement/1814/722420/Abstract-1814-A-long-acting-and-CD122-enhanced-IL

A long-acting and CD122-enhanced IL-2 analog, HM16390 ... After two weeks treatment in CT26 mice, complete response (CR) was observed in 89% and 100% of the mice by once weekly treatment of HM16390 at ...

4. hanmi.co.kr hanmi.co.kr/science-pdf/HM16390/2023_AACR_Poster_IL-2_1814.pdf

HM16390 - A Long-acting and CD122-enhanced IL-2 ... In particular, all mice in the 8.5 mg/kg treated group showed a complete response (CR), whereas only 22% of the mice showed CR after treatment with aldesleukin.

5. jitc.bmj.com jitc.bmj.com/content/13/Suppl_2/A971

859 HM16390, a long-acting IL-2 analog with enhanced ... However, they have failed to demonstrate sufficient safety and efficacy in clinical trials. Given the intrinsic role of Tregs in maintaining ...

6. jitc.bmj.com jitc.bmj.com/content/12/Suppl_2/A1062

943 Favorable safety profile of a novel long-acting IL-2, ... ... safety has been demonstrated in rodents and non-human primates, and these findings support HM16390 as a safe and effective immuno-oncology agent

7. clinicaltrials.gov clinicaltrials.gov/study/NCT06724016

Dose Escalation and Expansion Study of HM16390 in ... 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 ...

8. researchgate.net researchgate.net/publication/385556898_943_Favorable_safety_profile_of_a_novel_long-acting_IL-2_HM16390_with_effective_control_of_systemic_toxicities_via_fine-tuned_CD25_engagement_in_animal_models

943 Favorable safety profile of a novel long-acting IL-2, ... Conclusions The CD25 binding characteristics within HM16390 was finely tuned to mitigate unwanted toxicity derived from uncontrolled immune cell ...

9. delta.larvol.com delta.larvol.com/Products/?ProductId=df901d6f-2a10-40e0-993e-c3955a5d3654

HM16390 / Hanmi ... HM16390 as a safe and effective immuno-oncology agent." Preclinical ... Clinical data • IND • Preclinical • Oncology. Print; Email; More sharing. Reddit.