Health TrialsbyHealthPanel

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

ConditionMalignant Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenyang Sunshine Pharmaceutical Co., LTD.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • SSS59

    Drug

    A humanized antibody targeting MUC17

Treatment groups

154 Participants
are divided into 4 treatment groups
Group A: Part A1Experimental treatment 1 intervention
Group B: Part A2Experimental treatment 1 intervention
Group C: Part A3Experimental treatment 1 intervention
Group D: Part BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

DLTs

Dose limiting toxicity

Time frame
21 days
2

Safety and tolerability

Safety and tolerability assessed by incidence and severity of adverse events

Time frame
during the intervention，Within 28 days of the last dose
3

MTD and RP2D

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

Time frame
through study completion, an average of 2 year

Secondary outcomes

1

Cmax of SSS59

Maximum concentration

Time frame
baseline, during the intervention and at the end of the study
2

Tmax of SSS59

Time to peak drug concentration

Time frame
baseline, during the intervention and at the end of the study
3

AUC0-last of SSS59

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

Time frame
baseline, during the intervention and at the end of the study
4

RO of SSS59

Receptor Occupancy

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shenyang Sunshine Pharmaceutical Co., LTD.

Lead sponsor

Source ClinicalTrials.gov
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