A First-in-human Study of SMP-656 in Subjects With Locally Advanced/ Metastatic HER2 Expressing or Mutated Solid Tumors
NCT07922096, Phase 1, Completed, Chengdu SciMount Pharmatech Co., Ltd.
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | A First-in-human Study of SMP-656 in Subjects With Locally Advanced/ Metastatic HER2 Expressing or Mutated Solid Tumors | ClinicalTrials.gov |
| NCT number | NCT07922096 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Phase 1 | ClinicalTrials.gov |
| Enrollment | 35 participants, actual | ClinicalTrials.gov |
| Lead sponsor | Chengdu SciMount Pharmatech Co., Ltd. | ClinicalTrials.gov |
| Conditions | HER2-Expressing Advanced Solid Tumors, HER2-Mutated Advanced Solid Tumors, Metastatic Solid Tumors | ClinicalTrials.gov |
| Interventions | SMP-656 Injection | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Incidence of Dose-Limiting Toxicity (DLT) | 21 days after the first dose of SMP-656 | Number and percentage of participants who experienced a protocol-defined DLT during the 21-day DLT observation period after the first SMP-656 infusion, graded according to NCI CTCAE v5.0 (hematologic, hepatic and non-hematologic/non-hepatic toxicities). | ClinicalTrials.gov |
| Primary | Maximum Tolerated Dose (MTD) and/or Recommended Phase II Dose (RP2D) | Through study completion, up to 27 months from first dose | The MTD and/or RP2D of SMP-656 determined from the integrated analysis of DLT, safety, pharmacokinetic and preliminary antitumor activity data across the five dose levels evaluated (0.5, 1.0, 1.5, 2.0 and 2.5 mg/kg). | ClinicalTrials.gov |
| Secondary | Objective Response Rate (ORR) Assessed by Investigators | From the date of first dose to the date of first radiological documentation of disease progression or death, whichever occurs first (up to 27 months) | ORR is the percentage of evaluable patients with a confirmed investigator-assessed response of complete response (CR) or partial response (PR) per RECIST v1.1. | ClinicalTrials.gov |
| Secondary | Duration of Response (DOR) | From first confirmed objective response (CR/PR) up to 27 months from first dose | DOR is the time from the date of first documented confirmed objective response (CR or PR per RECIST v1.1) until the date of disease progression or death. | ClinicalTrials.gov |
| Secondary | Progression-Free Survival (PFS) | From the date of first dose to the date of first radiological documentation of disease progression or death, whichever occurs first (up to 27 months) | PFS is the time from the date of first dose until the date of objective radiographic disease progression or death (by any cause in the absence of progression). | ClinicalTrials.gov |
| Secondary | 1-Year Overall Survival Rate | 1 year after the first dose | Proportion of participants alive 1 year after the first dose of SMP-656. | ClinicalTrials.gov |
| Secondary | Area Under the Concentration Versus Time Curve (AUC) of Serum SMP-656 Following First Dose | Post first dose up to 2 years | The serum PK parameters of SMP-656 and its analytes for area under the concentration-versus-time curve from time 0 to the last quantifiable concentration as calculated by the linear-up log-down trapezoidal method (AUClast) and AUC from time 0 to infinity (AUCinf) elimination rate constant associated with the terminal phase were estimated using standard non-compartmental methods. | ClinicalTrials.gov |
| Secondary | Pharmacokinetic Analysis: Maximum (Peak) Observed Serum Concentration (Cmax) of Serum SMP-656 Following First Dose | Post first dose up to 2 years | The serum PK parameters Maximum (peak) Observed serum concentration of SMP-656 and its analytes were estimated using standard non-compartmental method. | ClinicalTrials.gov |
| Secondary | Pharmacokinetic Analysis: Time of Maximum Plasma Concentration (Tmax) of Serum SMP-656 Following First Dose | Post first dose up to 2 years | The serum PK parameters of Time of maximum plasma concentration (Tmax) for SMP-656 and its analytes were estimated using standard non-compartmental methods. | ClinicalTrials.gov |
| Secondary | Pharmacokinetic Analysis: Terminal Elimination Half-life (t1/2) of SerumSMP-656 Following First Dose | Post first dose up to 2 years | The serum PK parameters of Terminal elimination half-life forSMP-656 and its analytes was estimated using standard non-compartmental methods. | ClinicalTrials.gov |
| Secondary | Overview of Treatment-emergent Adverse Events | Baseline up to 28 days after the last dose of study drug | Treatment-emergent adverse events were graded by Common Terminology Criteria for Adverse Event | 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)