Clinical trial · Interventional
A Phase I Clinical Study of SSS59 Monotherapy in Patients With Advanced Malignant Tumors
A Phase I Clinical Study of the Safety, Pharmacokinetics, and Antitumor Activity of SSS59 in Patients With Advanced Malignant Tumors
NCT06944444CI-TRIAL-00089041recruitingPhase 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)
This study was an open-label phase I study to evaluate the safety, pharmacokinetics, and antitumor activity of SSS59 as a single agent in patients with advanced malignancies.
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 |
|---|---|---|---|
| Malignant Tumors | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SSS59 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Part A1
- description
- Dose escalation will be conducted using accelerated titration and traditional 3+3 design. Dose Escalation Level includes 12 levels, QW IV. Dose extension will be carried out at the selected level.
- interventionNames
- Drug: SSS59
- type
- EXPERIMENTAL
- label
- Part A2
- description
- Dose escalation will be conducted using a traditional 3+3 design. Dose Escalation Level includes 12 levels, Q2W IV. Dose extension will be carried out at the selected level.
- interventionNames
- Drug: SSS59
- type
- EXPERIMENTAL
- label
- Part A3
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically and/or cytologically documented local advanced or recurrent or metastatic malignancies. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. * Expected survival \>3 months. * Signed informed consent form. * Must have adequate organ function. Exclusion Criteria: * Any remaining AEs \> grade 1 from prior anti-tumor treatment as per CTCAE v5. 0, with exception of hair loss and fatigue. * Pregnant or nursing women or women/men who are ready to give birth. * symptomatic central nervous system metastasis. * Allergy to other antibody drugs or any excipients in the study drugs. * Underwent major surgery within 4 weeks prior to first dosing. * The patient is participating in another clinical study, unless it is an observational (non-intervention) clinical study or a follow-up period of an intervention study. The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
References
Publications (0)
Data not yet available
No reference posted for this study.