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

NCT06944444 | Recruiting Phase 1

• 1 other identifier: SSS59-101
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

Brief Summary

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

Malignant Tumors

Outcome Measures

Primary Outcomes (3)

• DLTs

  Dose limiting toxicity

  21 days

• Safety and tolerability

  Safety and tolerability assessed by incidence and severity of adverse events

  during the intervention，Within 28 days of the last dose

• MTD and RP2D

  Determine the maximum tolerated dose and determine the recommended phase II dose

  through study completion, an average of 2 year

Secondary Outcomes (7)

• Cmax of SSS59

  baseline, during the intervention and at the end of the study

• Tmax of SSS59

  baseline, during the intervention and at the end of the study

• AUC0-last of SSS59

  baseline, during the intervention and at the end of the study

• RO of SSS59

  baseline, during the intervention and at the end of the study

• Pharmacodynamic (PD) characteristics of SSS59

  baseline, during the intervention and at the end of the study

Study Arms (4)

Part A1

EXPERIMENTAL

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.

Drug: SSS59

Part A2

EXPERIMENTAL

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.

Drug: SSS59

Part A3

EXPERIMENTAL

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

Drug: SSS59

Part B

EXPERIMENTAL

Indication extension will be carried out at the selected level.

Drug: SSS59

Interventions

SSS59 DRUG

A humanized antibody targeting MUC17

Part A1; Part A2; Part A3; Part B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenyang Sunshine Pharmaceutical Co., LTD.: lead

Study Sites (1)

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Qi Li, MD

CONTACT

86+13818207333; Leeqi2001@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2025
• First Posted: April 25, 2025
• Study Start: April 27, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)