Trial · NCT07363408
Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment of Microsatellite Stable Advanced/Metastatic Colorectal Cancer
NCT07363408, Phase 1, Not yet recruiting, City of Hope Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment of Microsatellite Stable Advanced/Metastatic Colorectal Cancer. Trials, record NCT07363408. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07363408
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ivonescimab and ADG126, Alone, and in Combination With Leucovorin and Fluorouracil or FOLFIRI Regimen for the Treatment of Microsatellite Stable Advanced/Metastatic Colorectal Cancer
- NCT number
- NCT07363408
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 30 participants, estimated
- Lead sponsor
- City of Hope Medical Center
- Conditions
- Advanced Microsatellite Stable Colorectal Carcinoma, Metastatic Microsatellite Stable Colorectal Carcinoma, Stage III Colorectal Cancer AJCC v8, Stage IV Colorectal Cancer AJCC v8
- Interventions
- Biospecimen Collection, Computed Tomography, Fluorouracil, Irinotecan, Ivonescimab, Leucovorin Calcium, Magnetic Resonance Imaging, Muzastotug
- First posted
- 2026-01-23
- Last updated
- 2026-09-02
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of dose limiting toxicities | Up to 6 weeks or 3 doses of ivonescimab, whichever is longer | Will be assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, by treatment arm. Descriptive statistics will be used for all safety, efficacy and immunogenicity parameters. Data will be summarized using descriptive statistics (number of subjects, mean, median, standard deviation, minimum, and maximum) for continuous variables and using frequencies and percentages for categorical variables. Differences among groups will be tested using the Fisher's exact test and Kruskal-Wallis test for categorical and continuous variables, respectively. |
| Secondary | Treatment-related adverse event rates | Up to 30 days after completion of study treatment | Will be assessed by NCI CTCAE version 5.0, delineated by grade and attribution, by treatment arm. Descriptive statistics will be used for all safety, efficacy and immunogenicity parameters. Data will be summarized using descriptive statistics (number of subjects, mean, median, standard deviation, minimum, and maximum) for continuous variables and using frequencies and percentages for categorical variables. Differences among groups will be tested using the Fisher's exact test and Kruskal-Wallis test for categorical and continuous variables, respectively. |
| Secondary | Objective response rate | From the start of the study treatment and disease progression or death due to any cause prior to receiving another therapy, whichever occurs first, assessed up to 2 years after completion of study treatment | Defined as rate of participants achieving confirmed complete response (CR) or partial response (PR), as assessed by the investigator using Response Evaluation Criteria in Solid Tumors 1.1. The point estimate and 95% confidence intervals will be provided using the Clopper-Pearson methods. Logistic regression modeling of responders (CR or PR) and non-responders will be used to estimate the level of association of treatment and objective response. |
| Secondary | Duration of response | From the time when a response is experienced to progression or death, assessed up to 2 years after completion of study treatment | Survival distributions will be estimated using the Kaplan-Meier (KM) method. Survival curves will be compared between groups using the log-rank test. Median and landmark time-point estimates will be based on the KM estimates. The average hazard ratios (HR) will be estimated using a Cox proportional-hazards model. An assessment of the proportional-hazards assumption will be performed, and an assessment of the time-dependent HR will be done. |
| Secondary | Progression-free survival | From the start of treatment to disease progression or death from any cause, whichever occurs first, assessed up to 2 years after completion of study treatment | Survival distributions will be estimated using the KM method. Survival curves will be compared between groups using the log-rank test. Median and landmark time-point estimates will be based on the KM estimates. The average HR will be estimated using a Cox proportional-hazards model. An assessment of the proportional-hazards assumption will be performed, and an assessment of the time-dependent HR will be done. |
| Secondary | Overall survival | From start of treatment to death due to any cause, assessed up to 2 years after completion of study treatment | Survival distributions will be estimated using the KM method. Survival curves will be compared between groups using the log-rank test. Median and landmark time-point estimates will be based on the KM estimates. The average HR will be estimated using a Cox proportional-hazards model. An assessment of the proportional-hazards assumption will be performed, and an assessment of the time-dependent HR will be done. |
| Secondary | Plasma concentrations of cleaved and intact ADG126 | Up to 30 days after completion of study treatment | Changes over time in the levels of biomarkers will be measured using Wilcoxon signed rank test and linear mixed effect model. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA033572 | Cancer Center Support Grant | CARPTEN, JOHN D. | BECKMAN RESEARCH INSTITUTE/CITY OF HOPE | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07363408
GET https://conductscience.org/api/trials/v1/NCT07363408/registered