Trial · NCT06332170
ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors
NCT06332170, Phase 1, Recruiting, Hansoh BioMedical R&D Company
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors. Trials, record NCT06332170. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06332170
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors
- NCT number
- NCT06332170
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 610 participants, estimated
- Lead sponsor
- Hansoh BioMedical R&D Company
- Conditions
- Advanced Solid Tumor
- Interventions
- HS-20093, Adebrelimab, Cisplatin/ Carboplatin, Cetuximab, Enzalutamide
- First posted
- 2024-03-27
- Last updated
- 2024-07-18
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) for combination-treatments | Up to day 21 from the first dose | To determine the MTD for further evaluation of HS-20093 with other anti-cancer agents in subjects with advanced solid tumors |
| 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, physical examination, electrocardiogram, etc. |
| Secondary | Objective response rate (ORR) determined by investigators | From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months | Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline. ORR is evaluated by the number of participants with best overall response of CR and PR (Confirmed CR/PR assessment require at least 1 repeat). For prostate cancer patients, ORR is determined by investigators according to RECIST 1.1 and Prostate Cancer Working Group 3 (PCWG3). |
| Secondary | Disease control rate (DCR) determined by investigators | From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months | Objective tumor response for target lesions will be assessed by imaging/measurement compared with the overall tumor burden at baseline. DCR was evaluated by the number of participants with best overall response of CR, PR and stable disease (SD) \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks); SD shall be assessed at least 5 weeks after the first dose\]. For prostate cancer patients, DCR is determined by investigators according to RECIST 1.1 and Prostate Cancer Working Group 3 (PCWG3). |
| Secondary | Duration of response (DoR) determined by investigators | From the first dose up to PD or death, whichever came first, assessed up to 24 months | DoR was defined as the period from the first occurrence of CR or PR to 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 \[Confirmed CR/PR assessment require at least one repeat (≥4 weeks)\]. For prostate cancer patients, DoR is determined by investigators according to RECIST 1.1 and Prostate Cancer Working Group 3 (PCWG3). |
| Secondary | Progression-free survival (PFS) determined by investigators according to RECIST 1.1 | From the first dose up to PD or death, whichever came first, assessed up to 24 months | PFS was defined as the time from random assignment or first dose to PD or death from any cause. |
| Secondary | Overall survival (OS) | From the first dose up to death, whichever came first, assessed up to 24 months | OS was defined as the time from random assignment or first dose to death from any cause. |
| Secondary | Radiographic progression-free survival (rPFS) determined by investigators according to RECIST 1.1 and PCWG3 | From the first dose up to PD or death from study, whichever came first, assessed up to 24 months | For prostate cancer patients, the rPFS is defined as the time from random assignment or first dose to the date of first documented PD per PCWG3 or death from any cause, whichever occurs first. |
| Secondary | Time to PSA progression (TTPP) | From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months | In participants with a decrease in PSA from baseline: ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir value, which is confirmed by a consecutive second value obtained ≥ 3 weeks later. In participants with no decrease in PSA from baseline: ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the baseline value after 12 weeks. |
| Secondary | Prostate-specific cancer antigen (PSA) response rate | From the first dose up to PD or withdrawal from study, whichever came first, assessed up to 24 months | PSA response is defined as a ≥ 50% decline in PSA from baseline with PSA confirmation ≥ 3 weeks after the first documented reduction in PSA of ≥ 50%. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
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/NCT06332170
GET https://conductscience.org/api/trials/v1/NCT06332170/registered