Trial · NCT06769425
HS-10502 Combination Treatment in Patients With Advanced Solid Tumors
NCT06769425, Phase 1, Recruiting, Jiangsu Hansoh Pharmaceutical Co., Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. HS-10502 Combination Treatment in Patients With Advanced Solid Tumors. Trials, record NCT06769425. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06769425
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- HS-10502 Combination Treatment in Patients With Advanced Solid Tumors
- NCT number
- NCT06769425
- Status
- Recruiting
- Phases
- Phase 1
- Enrollment
- 157 participants, estimated
- Lead sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
- Conditions
- Recurrent Ovarian Cancer, HER2-negative, Advanced Breast Cancer, TNBC, Advanced Prostate Cancer, Advanced Gastric Cancer
- Interventions
- HS-10502 + NHA, HS-10502 + HS-20093, HS-10502+ Apatinib, HS-10502 + HS-20089, HS-10502 + Platinum + Bevacizumab, HS-10502 + nab-paclitaxel or Docetaxel or Irinotecan, HS-10502 + Bevacizumab
- First posted
- 2025-01-10
- Last updated
- 2025-06-24
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum tolerated dose (MTD) of HS-10502（Stage 1：Dose escalating stage） | Cycle 1 (21 days) | MTD is defined as the previous dose level at which 2 or more out of 2-6 subjects experienced a DLT. |
| Primary | Maximum applicable dose (MAD) of HS-10502（Stage 1：Dose escalating stage） | Cycle 1 (21days) | MAD is defined as follows: a) based on PK data, it is anticipated that at this dose level, the dose-exposure plateau has been reached, b) based on existing safety data, it is judged that dose escalation following this dose level will have a large safety risk or subject intolerance, or c) based on the PK-PD model, it suggested that the optimal target concentration of safety and efficacy has been explored. |
| Primary | Efficacy of HS-10502: Objective response rate (ORR)（Stage 2： Dose expansion stage） | From the date of first dose until the date of disease progression or withdrawal from study, approximately 2 years | ORR is defined as the proportion of participants with BOR of confirmed CR or confirmed PR per RECIST v1.1 (applicable for all solid tumors except prostate cancer) or per RECIST v1.1 and PCWG3 (for prostate cancer only). |
| Secondary | Incidence and severity of treatment-emergent adverse events | From Cycle 1 Day 1 (C1D1) until 21 days after the final dose. A cycle is 21days. | Assessed by number and severity of adverse events as evaluated according to NCI CTCAE v5.0. |
| Secondary | PK parameters: The maximum observed concentration (Cmax) of HS-10502 | Cycle 1 Day 1 (each cycle is 21 days) | Defines as the maximum plasma drug concentration of HS-10502 |
| Secondary | PK parameters: time to Cmax (Tmax) of HS-10502 | Cycle 1 Day 1 (each cycle is 21 days) | Time of maximum observed concentration of HS-10502. |
| Secondary | PK parameters: area under the concentration-time curve from time 0 to time t of last measurable concentration (AUC0-t) of HS-10502. | Cycle 1 Day 1 (each cycle is 21 days) | Area under the curve from the time of dosing to the time of the last measurable (positive) concentration. |
| Secondary | PK parameters: Maximum plasma concentration at steady state (Css, max) of HS-10502 | Cycle 2 Day 1 (each cycle is 21 days) | Defines as the maximum plasma drug concentration at steady state of HS-10502. |
| Secondary | PK parameters: time to Css, max (Tss, max) of HS-10502 | Cycle 2 Day 1 (each cycle is 21 days) | Time of maximum observed concentration at steady state of HS-10502. |
| Secondary | PK parameters: Minimum plasma concentration at steady state (Css, min) of HS-10502 | Cycle 2 Day 1 (each cycle is 21 days) | Minimum plasma drug concentration at steady state of HS-10502. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 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/NCT06769425
GET https://conductscience.org/api/trials/v1/NCT06769425/registered?page=2