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NCT Number: NCT06944444

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Shanghai First People's Hospital

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Wenqian Geng

CONTACT

[email protected]

86+021-36126254

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SSS59

Drug

A humanized antibody targeting MUC17

Primary outcomes

  1. DLTs

    Time frame: 21 days

    Dose limiting toxicity

  2. Safety and tolerability

    Time frame: during the intervention,Within 28 days of the last dose

    Safety and tolerability assessed by incidence and severity of adverse events

  3. MTD and RP2D

    Time frame: through study completion, an average of 2 year

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

Secondary outcomes

  1. Cmax of SSS59

    Time frame: baseline, during the intervention and at the end of the study

    Maximum concentration

  2. Tmax of SSS59

    Time frame: baseline, during the intervention and at the end of the study

    Time to peak drug concentration

  3. AUC0-last of SSS59

    Time frame: baseline, during the intervention and at the end of the study

    the area under the curve (AUC) up to the last measurable concentration

  4. RO of SSS59

    Time frame: baseline, during the intervention and at the end of the study

    Receptor Occupancy

  5. Pharmacodynamic (PD) characteristics of SSS59

    Time frame: baseline, during the intervention and at the end of the study

    change of cytokine

  6. Immunogenicity of SSS59

    Time frame: baseline, during the intervention and at the end of the study

    ADA,NAB(if ADA is positive)

  7. Preliminary antitumor activity of SSS59

    Time frame: baseline, during the intervention and at the end of the study

    Assessed according to Recist V1.1

Study contacts

Contact information is provided by the study sponsor or research team.

Qi Li, MD

CONTACT

[email protected]

86+13818207333

Sponsors and collaborators

Lead sponsor

Shenyang Sunshine Pharmaceutical Co., LTD.

Industry

Registry information

Official study title

A Phase I Clinical Study of the Safety, Pharmacokinetics, and Antitumor Activity of SSS59 in Patients With Advanced Malignant Tumors

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 25, 2025
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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