A Phase I Clinical Study of SSS59 Monotherapy in Patients With Advanced Malignant Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SSS59.
- Who it may be relevant to
- Registry conditions: Malignant Tumors. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Phase I Clinical Study of the Safety, Pharmacokinetics, and Antitumor Activity of SSS59 in Patients With Advanced Malignant Tumors
Overview
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.
Detailed description
This study includes 4 Parts: Part A1 (dose escalation and dose extension for QW administration), Part A2 (dose escalation and dose extension for Q2W administration), Part A3 (dose extension for Q3W administration), and Part B (indication extension, such as advanced gastric or gastroesophageal junction adenocarcinoma with MUC17 positive, failure of standard therapy, or intolerance to standard therapy , or other tumors).
Interventions
- Drug SSS59
A humanized antibody targeting MUC17
Primary outcome measures
- DLTs [Time frame: 21 days]
- Safety and tolerability [Time frame: during the intervention，Within 28 days of the last dose]
- MTD and RP2D [Time frame: through study completion, an average of 2 year]
Secondary outcome measures (7)
- Cmax of SSS59 [Time frame: baseline, during the intervention and at the end of the study]
- Tmax of SSS59 [Time frame: baseline, during the intervention and at the end of the study]
- AUC0-last of SSS59 [Time frame: baseline, during the intervention and at the end of the study]
- RO of SSS59 [Time frame: baseline, during the intervention and at the end of the study]
- Pharmacodynamic (PD) characteristics of SSS59 [Time frame: baseline, during the intervention and at the end of the study]
- Immunogenicity of SSS59 [Time frame: baseline, during the intervention and at the end of the study]
- Preliminary antitumor activity of SSS59 [Time frame: baseline, during the intervention and at the end of the study]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Shanghai First People's Hospital — Shanghai
Identifiers
NCT: NCT06944444 · SSS59-101