Clinical trial · Interventional
A Study of CSPCHA131 in Patients With Advanced Solid Tumor
A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of CSPCHA131 in Patients With Advanced Solid Tumors
NCT04325711CI-TRIAL-00049288unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study was designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of CSPCHA131 alone or plus chemotherapy in patients with advanced solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CSPCHA131 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CSPCH131 dose Escalation and expansion
- description
- In the dose escalation part of Stage I, five dose levels will be tested according to the "3 + 3" dose-escalation design. Whether and how to carry out the follow-up study parts will be decided by the PI and sponsor on the basis of the achieved results of safety, tolerability and effectiveness of CSPCHA131.
- interventionNames
- Drug: CSPCHA131
Primary outcomes (2)
- measure
- Maximum tolerated dose (MTD) and incidence of dose limiting toxicity (DLT) within the first cycle at each dose level.
- timeFrame
- Time Frame: 28 days
- measure
- Incidence of adverse events (AEs) and serious adverse events throughout the trial;
- timeFrame
- from enrollment to the end of the trial (2 years)
Secondary outcomes (13)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 1.18-75 years of age. * 2\. Histologically or cytologically confirmed diagnosis of advanced or metastatic malignant solid tumors, for which standard therapy either does not exist or has been proven ineffective or intolerable for the patient. * 3\. At least one measurable tumor lesion according to RECIST version 1.1. * 4\. ECOG performance status of 0 or 1. * 5\. Life expectancy ≥ 3 months. No cardiac insufficiency or serious abnormalities in the electrocardiogram at baseline. Exclusion Criteria: * 1\. Administration of chemotherapy, radiotherapy, biotherapy, endocrine therapy, targeted therapy, immunotherapy, other anti-tumor treatments or an investigational drug within 4 weeks or 5 half-lives, whichever is longer, preceding the first dose of study treatment. * 2\. Have undergone surgery within 4 weeks prior to the study treatment or have not fully recovered from any previous invasive procedure. * 3\. Adverse reactions to previous anti-tumor treatments that levels have not recovered to grade 1 or less. * 4\. Patients with evidence of uncontrolled nervous system metastasis or meningeal metastases, in the opinion of the investigator, not suitable for enrollment. * 5\. Active infections of grade 2 or above. * 6\. Peripheral neuropathy of grade 2 or above.
References
Publications (0)
Data not yet available
No reference posted for this study.