OncoMatch/Clinical Trials/NCT07094204
A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors
Official title: A Phase 1 Study of ASP5834 in Participants With Locally Advanced (Unresectable) or Metastatic Solid Tumor Malignancies With KRAS Mutations or KRAS Amplifications
Is NCT07094204 recruiting? Yes, currently enrolling (Oct 2026). This Phase 1 trial studies multiple treatments including ASP5834 and panitumumab for solid tumor.
Treatment: ASP5834 · panitumumab — Genes contain genetic code which tell the body which proteins to make. Many types of cancer are caused by changes, or mutations, in a gene called KRAS. Researchers are looking for ways to stop the actions of abnormal proteins made from the mutated KRAS gene. ASP5834 is being studied in people with solid tumors who have certain KRAS gene mutations. Some people with solid tumors of the colon or rectum (colorectal cancer), will be given ASP5834 with panitumumab. Panitumumab is a treatment for colorectal cancer. In this study, the researchers will learn how ASP5834 is processed by and acts upon the body. This information will help find a suitable dose of ASP5834 and check for any potential medical problems from the treatment. The main aims of this study are to check the safety of ASP5834 given by itself or given with panitumumab, and how well it is tolerated; and to find a suitable dose of ASP5834 given by itself or given with panitumumab. People in this study will be adults with locally advanced, unresectable, or metastatic solid tumors with certain KRAS gene mutations. Locally advanced means the cancer has spread to nearby tissue. Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread to other parts of the body. They either haven't responded to standard treatment or couldn't be given standard treatment. The key reasons people cannot take part are if they have specific uncontrollable cancers such as symptomatic or untreated cancers in nervous system, have specific heart conditions, swelling and irritation of lung tissues (pneumonitis or interstitial lung disease, also called ILD), infections, or have recently had a stroke or a bleed on the brain. In this study, ASP5834 is being given to humans for the first time. This is an open-label study. This means that people in this study and clinic staff will know that they will receive ASP5834 by itself or ASP5834 with panitumumab. This study will be in 2 parts: Part 1 is called Dose Escalation. Different small groups of people will receive lower to higher doses of either: ASP5834 by itself or ASP5834 with panitumumab. 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, all medical problems will be recorded. A medical expert panel will check the results and decide if the next group can receive a higher dose of ASP5834. The panel will do this until the planned maximum number of people are treated or until suitable doses have been selected for Part 2. Part 2 is called Dose Expansion. Other different small groups of people will receive ASP5834 or ASP5834 with panitumumab. They will receive the most suitable doses worked out from Part 1. In both parts of the study, the study treatments ASP5834 and panitumumab will be given through a vein. This is called an infusion. Each study treatment cycle is either 21 days or 28 days long. People will continue study treatment until: they have medical problems from the study treatment they can't tolerate; their cancer gets worse; they start other cancer treatment; or they ask to stop study treatment. People will visit the clinic on certain days during their study treatment, with extra visits during the first 2 cycles of study treatment. The study doctors will check for any medical problems from ASP5834. Also, people in the study will have a health check. On some visits they will also have scans to check for any changes in their cancer. Tumor samples will be taken at certain visits during study treatment with the option of a tumor sample being taken if people's cancer gets worse or the cancer comes back. People will visit the clinic shortly after stopping treatment for a health check. After this, people will have health checks every couple of months to check the condition of their cancer. The number of visits and checks done will depend on the health of each person and whether they completed their study treatment or not. It is expected that people will be in this study for about 1 year.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Tumor Agnostic
Non-Small Cell Lung Carcinoma
Pancreatic Cancer
Colorectal Cancer
Biomarker criteria
Required: KRAS amplification
Required: KRAS g12a
Required: KRAS g12c
Required: KRAS g12d
Required: KRAS g12r
Required: KRAS g12v
Required: KRAS g13d
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard therapy in the advanced setting — advanced setting (all solid tumors, monotherapy dose escalation/expansion, other solid tumor expansion)
Participant must have received prior standard therapy in the advanced setting, and the investigator does not see any further clinical benefit from continuing such therapy or the participant is ineligible to receive standard approved therapies.
Must have received: gemcitabine-based or fluoropyrimidine-based regimen — advanced setting (PDAC expansion)
[PDAC Expansion Cohort(s)] prior therapy with a gemcitabine-based or fluoropyrimidine-based regimen or is ineligible for these therapies
Must have received: platinum-based chemotherapy — advanced setting (NSCLC expansion)
[NSCLC Expansion Cohort(s)] prior platinum-based chemotherapy
Must have received: checkpoint inhibitor — advanced setting (NSCLC expansion)
[NSCLC Expansion Cohort(s)] prior checkpoint inhibitor therapy
Must have received: approved targeted therapy for actionable genomic alterations — advanced setting (NSCLC expansion, if actionable alteration present)
[NSCLC Expansion Cohort(s)] Participants with known actionable genomic alterations (AGA) must have received prior therapy with an approved targeted therapy in accordance with local requirements.
Must have received: fluoropyrimidine — advanced setting (CRC dose escalation/expansion)
[CRC Dose Escalation and Dose Expansion Parts] prior therapy with fluoropyrimidine
Must have received: oxaliplatin — advanced setting (CRC dose escalation/expansion)
[CRC Dose Escalation and Dose Expansion Parts] prior therapy with oxaliplatin
Must have received: irinotecan — advanced setting (CRC dose escalation/expansion)
[CRC Dose Escalation and Dose Expansion Parts] prior therapy with irinotecan
Must have received: anti-vascular endothelial growth factor (VEGF) therapy — advanced setting (CRC dose escalation/expansion)
[CRC Dose Escalation and Dose Expansion Parts] prior anti-vascular endothelial growth factor (VEGF) therapy
Must have received: immune checkpoint inhibitor — advanced setting (CRC with MSI-H or dMMR)
[CRC Dose Escalation and Dose Expansion Parts] prior treatment with immune checkpoint inhibitors (for MSI-H or dMMR CRC)
Cannot have received: KRAS targeting agent
Exception: In the dose escalation part, a participant with PDAC or NSCLC who has received prior RMC-6236 or RMC-9805 or a participant with NSCLC who has received prior KRAS G12C inhibitors but no other KRAS targeting agents will be eligible.
Participant has received prior KRAS targeting agents (including but not limited to KRAS directed inhibitors, degraders, siRNA therapies, vaccines and cellular therapies), with the following exceptions: In the dose escalation part, a participant with PDAC or NSCLC who has received prior RMC-6236 or RMC-9805 or a participant with NSCLC who has received prior KRAS G12C inhibitors but no other KRAS targeting agents will be eligible.
Lab requirements
Blood counts
adequate organ function as indicated by laboratory values
Kidney function
adequate organ function as indicated by laboratory values
Liver function
adequate organ function as indicated by laboratory values
Cardiac function
LVEF >= 50% by ECHO or MUGA; no recent MI/unstable angina/clinically significant cardiac disease; QTcF <= 450 msec (men) or <= 470 msec (women); resting HR >= 50 bpm; no long QT syndrome; no obligate pacemaker use
adequate organ function as indicated by laboratory values; LVEF < 50% as assessed by echocardiogram (ECHO) (or MUGA); QTcF value (single ECG) of > 450 msec (men) or > 470 msec (women); resting heart rate < 50 bpm at screening; no recent MI/unstable angina/clinically significant cardiac disease
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- UCLA Santa Monica Hematology Oncology · Santa Monica, California
- Winship Cancer Institute at Emory University · Atlanta, Georgia
- Ochsner Health · Jefferson, Louisiana
- START Midwest · Grand Rapids, Michigan
- Washington University School of Medicine · St Louis, Missouri
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT07094204 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior KRAS targeting agent disqualifies patients from enrollment.
Does this trial require KRAS?
Yes, KRAS amplification is a required biomarker for enrollment.
Does this trial require KRAS?
Yes, KRAS g12a is a required biomarker for enrollment.
Does this trial require KRAS?
Yes, KRAS g12c is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify