Trial · NCT05279300
A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas
NCT05279300, Phase 1, Suspended, CStone Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas. Trials, record NCT05279300. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05279300
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of CS5001 in Patients With Advanced Solid Tumors and Lymphomas
- NCT number
- NCT05279300
- Status
- Suspended
- Phases
- Phase 1
- Enrollment
- 480 participants, estimated
- Lead sponsor
- CStone Pharmaceuticals
- Conditions
- Advanced Solid Tumor, Advanced Lymphoma
- Interventions
- CS5001, Rituximab, Gemcitabine, Oxaliplatin, Lenalidomide, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
- First posted
- 2022-03-15
- Last updated
- 2026-09-01
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of CS5001 if any (for dose escalation part) | About 6 months | Participants will receive CS5001 for injection once every three weeks. The MTD will be determined by the number of participants who experience a dose limiting toxicity (DLT). |
| Primary | Recommended Phase 2 Dose(RP2D) of CS5001 (for dose escalation part) | About 6 months | The selection of RP2D will be based on consideration of overall safety information together with available pharmacokinetic, pharmacodynamic, and efficacy data. The RP2D may be the MTD or may be a lower dose within the tolerable dose range. |
| Primary | Incident and severity of adverse events | Until 90 days since the last dose of investigational product or until initiation of a new anti-cancer treatment, whichever occurs first | |
| Primary | Objective Response Rate (ORR) (for dose expansion) | Up to 2 years | The percentage of participants with a CR or PR based on 2014 Lugano Classification Criteria for lymphomas, iwCLL 2018 guidelines for CLL/SLL and RECIST v1.1 for solid tumors. |
| Secondary | Concentration of CS5001 total antibody | Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first | |
| Secondary | Concentration of anti-CS5001 antibodies | Up to 30 days since the last dose of or until initiation of a new anti-cancer treatment, whichever occurs first | |
| Other | Anti-tumor activity of CS5001 at RP2D in patient with selected advanced cancers (For dose expansion part) | About up to 12 months |
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/NCT05279300
GET https://conductscience.org/api/trials/v1/NCT05279300/registered