Trial · NCT07899086
A Phase I Study of HS-20093 Injection in Combination Therapy in Non-Small Cell Lung Cancer
NCT07899086, Phase 1, Not yet recruiting, Hansoh BioMedical R&D Company
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Phase I Study of HS-20093 Injection in Combination Therapy in Non-Small Cell Lung Cancer. Trials, record NCT07899086. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07899086
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Phase I Study of HS-20093 Injection in Combination Therapy in Non-Small Cell Lung Cancer
- NCT number
- NCT07899086
- Status
- Not yet recruiting
- Phases
- Phase 1
- Enrollment
- 102 participants, estimated
- Lead sponsor
- Hansoh BioMedical R&D Company
- Conditions
- Non-Small Cell Lung Cancer
- Interventions
- HS-20093, Ivonescimab, Chemotherapy
- First posted
- 2026-10-27
- Last updated
- 2026-10-27
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Phase 1a: Dose-Limiting Toxicity (DLT) | Through out the DLT period, approximately 21 days | Evaluate the number of patients with dose-limited toxicities (DLTs) |
| Primary | Phase 1b: Objective response rate (ORR) determined by investigators according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at phase 1b | From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 48 months. | ORR was defined as the percentage of participants who achieved a best overall response (BOR) of confirmed Complete Response (CR) or Partial Response (PR), assessed by investigators based on RECIST version 1.1\[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\]. |
| Secondary | Incidence and severity of adverse events (AEs) | From the first dose through 90 days post end of treatment. | AE assessed by investigator exclusively related to subject's underlying disease or medical condition \[graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0\]. Any untoward medical occurrence in a clinical study participant, whether or not considered related to the medicinal product. Incidence and severity of AEs are assessed according to vital signs, laboratory variables, electrocardiogram, etc. |
| Secondary | Duration of response (DoR) determined by investigators according to RECIST 1.1 | From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 48 months. | DoR was defined as the period from the first occurrence of CR or PR to progressive disease (PD) or death from any cause. If no PD or death after CR/PR, the cut-off date of progression-free survival (PFS) would be used \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\]. |
| Secondary | Disease control rate (DCR) determined by investigators according to RECIST 1.1. | From the first dose up to disease progression or withdrawal from study, whichever came first, assessed up to 48 months. | Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose\]. |
| Secondary | Progression-free survival (PFS) determined by investigators according to RECIST 1.1 | From the first dose or random assignment up to disease progression or withdrawal from study, whichever came first, assessed up to 48 months. | Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline (Day -28 to -1). PFS was defined as the time from first dose or random assignment (if any) to PD or death from any cause. |
| Secondary | Overall survival (OS) | From the first dose or random assignment up to death or withdrawal from study, whichever came first, assessed up to 48 months. | OS was defined as the time from the first dose or random assignment (if any) to death from any cause. |
| Secondary | Observed maximum plasma concentration (Cmax) of HS-20093 | Till study completion, approximately 48 months. | Cmax will be obtained following administration of the first dose of HS-20093 during the first cycle. |
| Secondary | Time to reach maximum plasma concentration (Tmax) of HS-20093 following the first dose | Till study completion, approximately 48 months. | Tmax will be obtained following administration of the first dose of HS-20093 during the first cycle |
| Secondary | Area under plasma concentration versus time curve from zero to last sampling time (AUC0-t) following the first dose of HS-20093 | Till study completion, approximately 48 months. | Area under the plasma concentration versus time curve from time zero to the last sampling time when the concentration was no less than the lower limit of quantification (LLQ). AUC0-t was calculated according to the mixed log-linear trapezoidal rule. |
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.
Grants0
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.
None in this release.
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/NCT07899086
GET https://conductscience.org/api/trials/v1/NCT07899086/registered