A Phase I Clinical Study of SSS59 Monotherapy in Patients With Advanced Malignant Tumors

Shenyang Sunshine Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Malignant Tumors

Treatments: Drug: SSS59

Study type: Interventional

Funder types: Industry

Identifiers

NCT06944444

SSS59-101

Details and patient eligibility

About

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.

Full 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).

Enrollment: 154 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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154 participants in 4 patient groups

Part A1

Experimental group

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.

Treatment:

Drug: SSS59

Part A2

Experimental group

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.

Treatment:

Drug: SSS59

Part A3

Experimental group

Description:

Dose extension will be carried out at the selected dose level, Q3W, IV.

Treatment:

Drug: SSS59

Part B

Experimental group

Description:

Indication extension will be carried out at the selected level.

Treatment:

Drug: SSS59