Rocatinlimab Delivery Methods in Healthy Participants

Recruiting at 6 trial locations

Overseen By Amgen Call Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Amgen

Must not be taking: Antibiotics, Antivirals, Antifungals, others

Disqualifiers: Arrhythmia, Hypertension, Hepatitis, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

231 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The main objective of this study is to evaluate the pharmacokinetics (PK) of rocatinlimab given as a single subcutaneous (SC) autoinjector dose compared to vial in healthy participants.

Do I have to stop taking my current medications for this trial?

Yes, you will need to stop taking most over-the-counter or prescription medications 30 days or 5 half-lives before Check-in, except for acetaminophen, hormonal contraception, and hormone replacement therapy. Herbal medicines, vitamins, and supplements are also restricted unless approved by the Investigator.

What safety data exists for Rocatinlimab (KHK4083, AMG-451)?

The provided research does not contain specific safety data for Rocatinlimab (KHK4083, AMG-451). The studies focus on other PD-1 inhibitors like dostarlimab, pembrolizumab, and nivolumab, and discuss their safety profiles, including risks like colitis. For Rocatinlimab-specific safety data, further research or clinical trial results would be needed. ^{1 2 3 4 5}

Is the drug Rocatinlimab a promising treatment in the trial titled 'Rocatinlimab Delivery Methods in Healthy Participants'?

The information provided does not directly address Rocatinlimab or its potential as a promising treatment. The articles focus on other drugs and treatments, so we can't determine Rocatinlimab's promise from this data. ^{1 2 4 6 7}

What data supports the idea that Rocatinlimab Delivery Methods in Healthy Participants is an effective treatment?

The available research does not provide specific data on Rocatinlimab Delivery Methods in Healthy Participants. Instead, it focuses on other treatments for advanced solid tumors, such as dostarlimab, cetrelimab, and pembrolizumab. These studies assess the safety and effectiveness of these drugs in treating cancer, but they do not offer information on Rocatinlimab's effectiveness for its intended use. ^{1 2 7 8 9}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

This trial is for healthy men and women aged 18-65 with a body mass index (BMI) between 18 and 32. Participants must consent to study procedures before starting.

Inclusion Criteria

Body mass index between 18 and 32 kg/m2 (inclusive)

Participant has provided informed consent before initiation of any study-specific activities/procedures

Exclusion Criteria

Alanine aminotransferase or aspartate aminotransferase > 1.5 times the upper limit of normal at Screening or Check-in

I have not received live vaccines recently and do not plan to within 3 months after starting the trial.

I have a history of significant heart rhythm problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subcutaneous dose of rocatinlimab via autoinjector or vial

1 day

1 visit (in-person)

Follow-up

Participants are monitored for treatment-emergent adverse events and any clinically significant changes in vital signs, ECG, and clinical laboratory tests

20 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Rocatinlimab

Trial Overview The trial is testing the bioavailability of Rocatinlimab, an atopic dermatitis treatment, by comparing its absorption in the body when administered via autoinjector versus traditional vial.

How Is the Trial Designed?

Group I: Treatment B Experimental Treatment 1 Intervention

Participants will be randomized to receive a single dose of rocatinlimab autoinjector for SC injection.

Group II: Treatment A Experimental Treatment 1 Intervention

Participants will be randomized to receive a single dose of rocatinlimab vial solution for SC injection.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Published Research Related to This Trial

A population pharmacokinetic model developed from data of 546 patients in the Phase 1 GARNET trial showed that dostarlimab, an anti-PD-1 antibody, has a well-defined pharmacokinetic profile with a terminal elimination half-life of approximately 23.5 days.

The study found that while certain patient characteristics like age, body weight, and sex influenced the drug's clearance and distribution, there were no clinically significant exposure-response relationships for efficacy or safety, supporting the recommended dosing regimen for dostarlimab.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population pharmacokinetics and exposure-response of anti-programmed cell death protein-1 monoclonal antibody dostarlimab in advanced solid tumours. Melhem, M., Hanze, E., Lu, S., et al.[2022]

Cetrelimab, a PD-1 inhibitor, was found to have a manageable safety profile in patients with advanced solid tumors, with 53.9% experiencing grade ≥3 adverse events, and 35.3% having immune-related adverse events.

In terms of efficacy, cetrelimab showed an overall response rate of 18.6% across various tumor types, with higher rates in specific cancers like non-small-cell lung cancer (34.3%) and melanoma (28.0%), indicating its potential as a treatment option for these conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-human, open-label, phase 1/2 study of the monoclonal antibody programmed cell death protein-1 (PD-1) inhibitor cetrelimab (JNJ-63723283) in patients with advanced cancers. Felip, E., Moreno, V., Morgensztern, D., et al.[2022]

Pembrolizumab was found to be safe and well tolerated in a phase I study involving 20 patients with advanced solid tumors, with no dose-limiting toxicities observed at doses up to 10 mg/kg every 2 weeks.

The treatment demonstrated durable antitumor activity, with complete responses in two patients and stable disease in 15 others, indicating that a minimum effective dose for antitumor activity is 2 mg/kg every 3 weeks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I Study of Pembrolizumab (MK-3475; Anti-PD-1 Monoclonal Antibody) in Patients with Advanced Solid Tumors. Patnaik, A., Kang, SP., Rasco, D., et al.[2022]

In a study of 196 cancer patients treated with PD-1 and PD-L1 inhibitors, the objective response rate was 29%, with a median overall survival of 10 months and median progression-free survival of 5 months, indicating these treatments are effective in a real-world setting.

The implementation of a standardized management protocol, including assessments by internal medicine specialists, improved the resolution of immune-related adverse events, highlighting the importance of proactive management in enhancing patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events Induced by PD-1/PD-L1 Inhibitors: A Real-World Single-Centre Experience with a Management-Based Approach. Grimaud, F., Penaranda, G., Stavris, C., et al.[2022]

In a study involving 1,453 patients with advanced melanoma and non-small cell lung cancer (NSCLC), pembrolizumab showed no dependency on dosage for overall survival, indicating that varying doses (2 to 10 mg/kg) did not significantly affect patient outcomes.

A strong association was found between the baseline clearance (CL0) of pembrolizumab and overall survival, suggesting that higher clearance rates may indicate more severe disease, rather than affecting the drug's efficacy directly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pembrolizumab Exposure-Response Assessments Challenged by Association of Cancer Cachexia and Catabolic Clearance. Turner, DC., Kondic, AG., Anderson, KM., et al.[2019]

In a study of 88 advanced melanoma patients treated with pembrolizumab, 81.8% experienced any-grade toxicities, with skin and gastrointestinal issues being the most common side effects.

Despite the high incidence of side effects, pembrolizumab was found to be well tolerated in real-world settings, and severe toxicities were manageable with systemic steroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world experience with pembrolizumab toxicities in advanced melanoma patients: a single-center experience in the UK. So, AC., Board, RE.[2022]

In a study involving 39 children with refractory solid tumors, the combination of cixutumumab and temsirolimus was found to have a maximum tolerated dose (MTD) of 6 mg/kg and 8 mg/m², with mucositis being the most common dose-limiting toxicity.

The treatment effectively inhibited mTOR signaling pathways, as evidenced by decreased levels of S6K1 and PAkt in blood cells, indicating a biological response to the therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase I Study of Cixutumumab (IMC-A12) in Combination with Temsirolimus (CCI-779) in Children with Recurrent Solid Tumors: A Children's Oncology Group Phase I Consortium Report. Fouladi, M., Perentesis, JP., Wagner, LM., et al.[2019]

In a meta-analysis of clinical trials, PD-1 inhibitors (like nivolumab and pembrolizumab) were found to have a higher incidence of colitis compared to PD-L1 inhibitors (like atezolizumab and durvalumab), with rates of 1.49% for all grade colitis and 0.85% for grade 3-4 colitis.

The analysis indicated that the relative risk of developing colitis with PD-1 inhibitors was significantly higher (1.80 for all grade colitis and 2.52 for grade 3-4 colitis), suggesting that patients receiving PD-1 inhibitors may need closer monitoring for this adverse effect.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and Risk of Colitis With Programmed Death 1 Versus Programmed Death Ligand 1 Inhibitors for the Treatment of Cancer. Miyashita, H., Mikami, T., Satoi, S., et al.[2021]

In a study of 10 patients with advanced non-small cell lung cancer (NSCLC), the combination of sintilimab immunotherapy with bronchial arterial infusion chemotherapy resulted in an impressive objective response rate of 80% and a complete disease control rate of 100%.

The treatment was found to be safe, with only two cases of Grade III adverse events reported, and it showed promising median progression-free survival of 11 months and overall survival of 8 months, suggesting that adding immunotherapy may enhance outcomes compared to previous treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sintilimab plus Bronchial Arterial Infusion Chemotherapy/Drug-Eluting Embolic Chemoembolization for Advanced Non-Small Cell Lung Cancer: A Preliminary Study of 10 Patients. Li, YM., Guo, RQ., Bie, ZX., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Population pharmacokinetics and exposure-response of anti-programmed cell death protein-1 monoclonal antibody dostarlimab in advanced solid tumours. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

First-in-human, open-label, phase 1/2 study of the monoclonal antibody programmed cell death protein-1 (PD-1) inhibitor cetrelimab (JNJ-63723283) in patients with advanced cancers. [2022]

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

Phase I Study of Pembrolizumab (MK-3475; Anti-PD-1 Monoclonal Antibody) in Patients with Advanced Solid Tumors. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Adverse Events Induced by PD-1/PD-L1 Inhibitors: A Real-World Single-Centre Experience with a Management-Based Approach. [2022]

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

Pembrolizumab Exposure-Response Assessments Challenged by Association of Cancer Cachexia and Catabolic Clearance. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Real-world experience with pembrolizumab toxicities in advanced melanoma patients: a single-center experience in the UK. [2022]

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

A Phase I Study of Cixutumumab (IMC-A12) in Combination with Temsirolimus (CCI-779) in Children with Recurrent Solid Tumors: A Children's Oncology Group Phase I Consortium Report. [2019]

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

Incidence and Risk of Colitis With Programmed Death 1 Versus Programmed Death Ligand 1 Inhibitors for the Treatment of Cancer. [2021]

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

Sintilimab plus Bronchial Arterial Infusion Chemotherapy/Drug-Eluting Embolic Chemoembolization for Advanced Non-Small Cell Lung Cancer: A Preliminary Study of 10 Patients. [2022]