A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors
NCT07923214, Phase 1, Recruiting, Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Phase I Study of CG-7321 Monotherapy or Combination Therapy in Advanced Solid Tumors | ClinicalTrials.gov |
| NCT number | NCT07923214 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 30 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Chengdu Cynogen Bio-pharmaceutical Tech. Co., Ltd. | ClinicalTrials.gov |
| Conditions | Advanced Solid Tumors, Breast Cancer, Ovarian Cancer, Gastric Cancer, Other Solid Tumors | ClinicalTrials.gov |
| Interventions | CG-7321 | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Dose-Limiting Toxicities (DLTs) | DLT observation period [approximately 28 days] | Number of participants experiencing DLTs during DLT evaluation period. | ClinicalTrials.gov |
| Primary | Maximum Tolerated Dose (MTD) | End of dose escalation phase [approximately 6-12 months] | The highest dose level at which ≤2/6 evaluable subjects experience DLT. | ClinicalTrials.gov |
| Primary | Recommended Phase 2 Dose (RP2D) | End of dose escalation phase [approximately 6-12 months] | The dose level recommended for Phase 2 studies. | ClinicalTrials.gov |
| Primary | Adverse Events (AEs) and SAEs | From first dose to 30 days after last dose [up to approximately 2 years] | Incidence and severity of AEs and SAEs, graded per NCI-CTCAE Version 5.0. | ClinicalTrials.gov |
| Secondary | Objective Response Rate (ORR) | Every 8 weeks [up to approximately 2 years] | Percentage achieving CR or PR per RECIST v1.1. | ClinicalTrials.gov |
| Secondary | Disease Control Rate (DCR) | Every 8 weeks [up to approximately 2 years] | Percentage achieving CR, PR, or SD per RECIST v1.1. | ClinicalTrials.gov |
| Secondary | Duration of Response (DoR) | From first documented response until disease progression or death [up to approximately 2 years] | Time from first documented response to disease progression or death. | ClinicalTrials.gov |
| Secondary | Progression-Free Survival (PFS) | From first dose until disease progression or death [up to approximately 2 years] | Time from first dose to disease progression per RECIST v1.1 or death. | ClinicalTrials.gov |
| Secondary | Overall Survival (OS) | From first dose until death [up to approximately 5 years] | Time from first dose to death from any cause. | ClinicalTrials.gov |
| Secondary | Observed plasma maximum concentration (Cmax) of CG-7321 and its metabolite | Cycle 0 Day 1, Cycle 1 Day 1 up to Cycle 6 Day 1 (each cycle is 28 days) | ClinicalTrials.gov | |
| Secondary | Area under the concentration-time curve (AUC) of CG-7321 and its metabolite | Cycle 0 Day 1, Cycle 1 Day 1 up to Cycle 6 Day 1 (each cycle is 28 days) | ClinicalTrials.gov | |
| Secondary | Half-life (T1/2) of CG-7321 and its metabolite | Cycle 0 Day 1, Cycle 1 Day 1 up to Cycle 6 Day 1 (each cycle is 28 days) | ClinicalTrials.gov | |
| Secondary | Time to maximum concentration（Tmax） of CG-7321 and its metabolite | Cycle 0 Day 1, Cycle 1 Day 1 up to Cycle 6 Day 1 (each cycle is 28 days) | ClinicalTrials.gov | |
| Other | Biomarkers | Baseline and during treatment as tissue samples become available [up to approximately 2 years] | Exploratory biomarker analysis including but not limited to CCNE expression levels. | ClinicalTrials.gov |
| Other | Tumor-to-blood drug concentration ratio | At time of tumor biopsy during treatment [up to approximately 2 years] | Ratio of CG-7321 and CG1-Mp2 concentrations in tumor tissue versus peripheral blood. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
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 | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)