A Clinical Study of MHB034C for Injection in Participants With Advanced Solid Tumors
NCT07928570, Phase 1, Phase 2, Not yet recruiting, Minghui Pharmaceutical (Shanghai) LTD
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A Clinical Study of MHB034C for Injection in Participants With Advanced Solid Tumors | ClinicalTrials.gov |
| NCT number | NCT07928570 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 1, Phase 2 | ClinicalTrials.gov |
| Enrollment | 400 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Minghui Pharmaceutical (Shanghai) LTD | ClinicalTrials.gov |
| Conditions | Advanced Malignant Solid Tumor | ClinicalTrials.gov |
| Interventions | MHB034C for Injection | ClinicalTrials.gov |
| First posted | 2026-11-10 | ClinicalTrials.gov |
| Last updated | 2026-11-10 | ClinicalTrials.gov |
Registered outcomes 28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Phase I Dose Escalation Stage: Incidence of DLT | At the end of Cycle 1 (each cycle is 21 days for Q3W administration and 28 days for Q2W administration) | ClinicalTrials.gov | |
| Primary | Phase I Dose Escalation Stage: Incidence of Adverse events (AEs) | from Day1 to 30 days after last dose | ClinicalTrials.gov | |
| Primary | Phase I Dose Escalation Stage: Incidence of Serious adverse events (SAEs) | from Day1 to 30 days after last dose | ClinicalTrials.gov | |
| Primary | Phase I Dose Escalation Stage: MTD | At the end of Cycle 1 (each cycle is 21 days for Q3W administration and 28 days for Q2W administration) | ClinicalTrials.gov | |
| Primary | Phase I Dose Escalation Stage: RP2D | from Day1 to 30 days after last dose | ClinicalTrials.gov | |
| Primary | Phase II Dose Expansion Stage: ORR as assessed by the investigator per RECIST v1.1. | One year after the last subject was enrolled in the group | ClinicalTrials.gov | |
| Primary | Phase II Dose Expansion Stage: DCR as assessed by the investigator per RECIST v1.1. | One year after the last subject was enrolled in the group | ClinicalTrials.gov | |
| Primary | Phase II Dose Expansion Stage: DoR as assessed by the investigator per RECIST v1.1. | One year after the last subject was enrolled in the group | ClinicalTrials.gov | |
| Primary | Phase II Dose Expansion Stage: PFS as assessed by the investigator per RECIST v1.1. | One year after the last subject was enrolled in the group | ClinicalTrials.gov | |
| Primary | Phase II Dose Expansion Stage: OS as assessed by the investigator per RECIST v1.1. | One year after the last subject was enrolled in the group | ClinicalTrials.gov | |
| Primary | Phase II Dose Expansion Stage: PFS rates at 6 and 12 months. | One year after the last subject was enrolled in the group | ClinicalTrials.gov | |
| Primary | Phase II Dose Expansion Stage: OS rates at 6 and 12 months. | One year after the last subject was enrolled in the group | ClinicalTrials.gov | |
| Secondary | Phase I Dose Escalation Stage: AUC0-t、AUC0-∞ of MHB034C | through study completion, an average of 2 years | ClinicalTrials.gov | |
| Secondary | Phase I Dose Escalation Stage: Cmax of MHB034C | through study completion, an average of 2 years | ClinicalTrials.gov | |
| Secondary | Phase I Dose Escalation Stage: Tmax of MHB034C | through study completion, an average of 2 years | ClinicalTrials.gov | |
| Secondary | Phase I Dose Escalation Stage: CL of MHB034C | through study completion, an average of 2 years | ClinicalTrials.gov | |
| Secondary | Phase I Dose Escalation Stage: t1/2 of MHB034C | through study completion, an average of 2 years | ClinicalTrials.gov | |
| Secondary | Phase I Dose Escalation Stage: Vss of MHB034C | through study completion, an average of 2 years | ClinicalTrials.gov | |
| Secondary | Phase I Dose Escalation Stage: Ctrough of MHB034C | through study completion, an average of 2 years | ClinicalTrials.gov | |
| Secondary | Phase I Dose Escalation Stage and Phase II Dose Expansion Stage: Positivity rate of anti-MHB034C antibodies (ADA) and their possible neutralizing antibodies (NAb) | through study completion, an average of 2 years | 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)