ASP5834 for Cancer

Recruiting at 3 trial locations

Overseen By Astellas Pharma Global Development, Inc.

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Astellas Pharma Inc

Must not be taking: CYP3A inhibitors, CYP3A inducers

Disqualifiers: CNS metastases, Active hepatitis, HIV, others

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

Compensation: Varies

Number of Visits: 2

364 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the appropriate dose and assess the safety of a new drug, ASP5834, for individuals with certain solid tumors that have KRAS gene mutations. It will investigate the effects of ASP5834 both alone and in combination with panitumumab, a treatment for colorectal cancer. The trial is open to those with advanced or metastatic cancers that cannot be surgically removed and have specific KRAS mutations. Participants will contribute to understanding how ASP5834 affects the body and its potential to control cancer growth. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in humans.

Do I have to stop taking my current medications for the ASP5834 trial?

The trial information does not specify if you need to stop taking your current medications. However, it mentions that participants cannot take part if they require treatment with certain drugs that affect liver enzymes (CYP3A inhibitors or inducers). It's best to discuss your current medications with the study team to see if they might affect your eligibility.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ASP5834 is being tested in humans for the first time, so limited safety information is available. This study aims to find a safe and suitable dose. ASP5834 is administered alone or with panitumumab, a drug already used for colorectal cancer. As this is an early-stage study, scientists closely monitor for any side effects as the dose increases. Any issues caused by ASP5834 or its combination with panitumumab are carefully recorded. The goal is to understand how well people tolerate the treatment at different doses. While panitumumab's safety is well-known, the effects of ASP5834 remain under investigation. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about ASP5834 for cancer treatment because it offers a novel approach compared to standard therapies. Unlike current treatments that often rely on chemotherapy or targeted therapies, ASP5834 introduces a new mechanism of action that targets specific tumor mutations and types, potentially allowing for more personalized and effective treatment. Additionally, ASP5834 can be administered both as a monotherapy and in combination with panitumumab, offering flexibility and potentially enhanced efficacy. This versatility and targeted approach could lead to improved outcomes for patients with specific types of tumors, making it a promising option in the oncology field.

What evidence suggests that ASP5834 might be an effective treatment for cancer?

Many studies have shown that changes in the KRAS gene cause certain cancers, leading to the production of harmful proteins. ASP5834, a new treatment tested in this trial, targets these proteins. Although ASP5834 lacks extensive human data, early results from similar treatments targeting KRAS changes have shown promise in other cancers. ASP5834 blocks the harmful effects of these proteins, potentially slowing or stopping cancer growth. This trial includes arms testing ASP5834 alone and in combination with panitumumab, a known colorectal cancer treatment, which could enhance its effectiveness against some tumors. Early signs are hopeful, but further research is needed to confirm its efficacy. ^{1 2 3 4 6}

Who Is on the Research Team?

Medical Lead

Principal Investigator

Astellas Pharma Inc

Are You a Good Fit for This Trial?

Adults with advanced solid tumors that can't be removed by surgery or have spread, and who have specific KRAS gene mutations. Not suitable for those with certain uncontrollable cancers, particular heart conditions, or infections. Only colorectal cancer patients will receive ASP5834 with panitumumab.

Inclusion Criteria

Unique to Europe (EU): Only participants who have pre-existing local results can be enrolled

My cancer is advanced, cannot be surgically removed, and has a specific KRAS mutation.

I will not donate sperm during the treatment.

Exclusion Criteria

Participant has a known or suspected hypersensitivity to the protocol specified study intervention(s) or any components of the formulation used

I have not needed IV antibiotics for an infection in the last 14 days.

Participant has received any investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive sequential dose levels of ASP5834, with or without panitumumab, to determine suitable doses

21-28 days per cycle

Multiple visits per cycle, with extra visits during the first 2 cycles

Dose Expansion

Participants receive the most suitable doses of ASP5834, with or without panitumumab, determined from Dose Escalation

21-28 days per cycle

Multiple visits per cycle

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 45 months

Health checks every couple of months

What Are the Treatments Tested in This Trial?

Interventions

• ASP5834

Trial Overview The trial is testing ASP5834 alone or combined with panitumumab in two parts: Dose Escalation to find a safe dose range and Dose Expansion to test the most suitable doses found. It's an open-label study where participants know what treatment they're receiving.

How Is the Trial Designed?

Group I: ASP5834 monotherapy therapy Dose Expansion Experimental Treatment 1 Intervention

Participants will receive 1 of 2 dose regimens of ASP5834.

Group II: ASP5834 combination therapy Dose Expansion Experimental Treatment 2 Interventions

Participants will receive ASP5834 and panitumumab with dose level(s) and regimen selected from dose escalation (Combination Therapy). Panitumumab will be administered every 2 weeks.

Group III: ASP5834 combination therapy Dose Escalation Experimental Treatment 2 Interventions

Participants will receive sequential doses levels of ASP5834 intravenously following 1 of 2 dose regimens based on emerging data. Panitumumab will be administered every 2 weeks.

Group IV: ASP5834 Dose Expansion (Tumor/ Mutation Specific) Experimental Treatment 1 Intervention

Participants with select tumor types will receive 1 of 2 dose regimens of ASP5834 with dose level(s) selected from dose escalation.

Group V: ASP5834 Dose Expansion (Dose-ranging) Experimental Treatment 1 Intervention

Participants will receive dose level(s) and regimen of ASP5834 based on emerging data from Dose Escalation alone or Dose Escalation and Dose Expansion cohorts.

Group VI: ASP5834 Dose Escalation Experimental Treatment 1 Intervention

Participants will receive sequential doses levels of ASP5834 intravenously following 1 of 2 dose regimens.

Who Is Running the Clinical Trial?

Astellas Pharma Inc

Lead Sponsor

Trials

700

Recruited

236,000+

Headquarters

Tokyo, Japan

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Tadaaki Taniguchi

Astellas Pharma Inc

Chief Medical Officer since 2023

MD, PhD

Naoki Okamura

Astellas Pharma Inc

Chief Executive Officer since 2023

University of Tokyo, Faculty of Pharmacy

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07094204

A Study to Find a Suitable Dose of ASP5834 in Adults ... Only people who have colorectal cancer will receive ASP5834 with panitumumab. People with any type of solid tumor will receive ASP5834 by itself. For each dose, ...

2. clinicaltrials.astellas.com clinicaltrials.astellas.com/study/5834-CL-1001

A study to find a suitable dose of ASP5834 in adults with ... Different small groups of people will receive lower to higher doses of either: ASP5834 by itself or ASP5834 together with panitumumab. Only people who have ...

3. withpower.com withpower.com/trial/phase-1-neoplasms-6-2025-6dff0

ASP5834 for Cancer · Recruiting Participants for Phase ... Only people who have colorectal cancer will receive ASP5834 with panitumumab. People with any type of solid tumor will receive ASP5834 by itself. For each dose, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12384933/

Clinical efficacy analysis of the combination of panitumumab ... This study aims to assess the efficacy and safety of combining panitumumab with paclitaxel as a first-line treatment for metastatic head and ...

5. linkedin.com linkedin.com/posts/the-start-center-for-cancer-research_kras-clinicalresearch-oncology-activity-7372264442895568896-UdNL

START Midwest completes first-in-human ASP5834 study ... ASP5834 will be tested both as a monotherapy and in combination with panitumumab ... outcomes for an all-oral SERD regimen combined with ...

6. tipranks.com tipranks.com/news/company-announcements/astellas-pharmas-asp5834-study-a-new-hope-for-kras-mutation-cancers

Astellas Pharma's ASP5834 Study: A New Hope for KRAS ... The study aims to find a suitable dose of ASP5834 in adults with solid tumors, focusing on safety and tolerability when administered alone or ...