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SSS59

Phase 1

Malignant Tumors | Small molecule | Oncology |Sunshine Biopharma Inc.|Last Updated: Apr 29, 2025

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment154

FDA Designations

No designations recorded

Clinical trial landscape

SSS59 · 1 trial · 1 indication

Phase 1 1
NCT06944444A Phase I Clinical Study of SSS59 Monotherapy in Patients With Advanced Malignant TumorsMalignant Tumors
RECRUITING154 Analytics
PHASE1RECRUITING
A Phase I Clinical Study of SSS59 Monotherapy in Patients With Advanced Malignant Tumors
Malignant TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

DLTs
21 days

Dose limiting toxicity

Safety and tolerability
during the intervention,Within 28 days of the last dose

Safety and tolerability assessed by incidence and severity of adverse events

MTD and RP2D
through study completion, an average of 2 year

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

Secondary Endpoints

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
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part A1EXPERIMENTALDose 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.
Part A2EXPERIMENTALDose 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.
Part A3EXPERIMENTALDose extension will be carried out at the selected dose level, Q3W, IV.
Part BEXPERIMENTALIndication extension will be carried out at the selected level.

Interventions

NameTypeDescription
SSS59DRUGA humanized antibody targeting MUC17
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

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. E...

Countries:China
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Frequently asked questions about SSS59

What is SSS59 used for?

SSS59 is an investigational small molecule being developed for the treatment of malignant tumors. It is currently being studied as a monotherapy in patients with advanced malignant tumors. The drug is in Phase 1 clinical development and has not yet been approved by regulatory authorities.

What does SSS59 target?

SSS59 is a small molecule therapeutic being developed for oncology. The specific molecular target of SSS59 has not been disclosed in available information. The drug is being evaluated in a Phase 1 clinical trial for its safety and efficacy in patients with advanced malignant tumors.

Who is developing SSS59?

SSS59 is being developed by Sunshine Biopharma Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol SBFM. The company is conducting a Phase 1 clinical trial of SSS59 as a monotherapy for the treatment of advanced malignant tumors.

What phase is SSS59 in?

SSS59 is currently in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. The ongoing Phase 1 trial is recruiting patients with advanced malignant tumors to evaluate the safety and tolerability of SSS59 as a monotherapy.

What clinical trials is SSS59 in?

SSS59 is being studied in a Phase 1 clinical trial with the identifier NCT06944444. This trial is titled 'A Phase I Clinical Study of SSS59 Monotherapy in Patients With Advanced Malignant Tumors' and is currently recruiting participants in China. The trial aims to enroll 154 patients aged 18 years and older.

Is SSS59 the same as any other drug?

SSS59 is a distinct investigational drug candidate developed by Sunshine Biopharma Inc. No alternative names for SSS59 have been disclosed in available information. It is being studied as a monotherapy for malignant tumors and is not known to be identical to any other approved or investigational drug.