Recent Updates
Recently added Catalysts

HEC169096

Phase 1

Advanced Solid Tumor | Small molecule | Oncology |Sunshine Biopharma Inc.|Last Updated: Apr 28, 2026

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment456

FDA Designations

No designations recorded

Clinical trial landscape

HEC169096 · 1 trial · 1 indication

Phase 1 1
NCT05451602HEC169096 in Participants With Advanced Solid TumorsAdvanced Solid Tumor
RECRUITING456 Analytics
PHASE1RECRUITING
HEC169096 in Participants With Advanced Solid Tumors
Advanced Solid TumorUnlock trial analytics

Study Endpoints

Primary Endpoints

Phase 1: MTD and RP2D of HEC169096
Cycle 1 (28 days) of treatment for MTD and at the end of every 2 cycle for RP2D for approximately 12 months or earlier if participant terminates from the study

Determination of Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D) of HEC169096

Phase 2: Overall Response Rate
through study completion, an average of 1 year

As assessed by Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

Unlock Study Endpoints

Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
HEC169096EXPERIMENTALMultiple doses of HEC169096

Interventions

NameTypeDescription
HEC169096DRUGMultiple doses of HEC169096 during Phase 2;Oral dose of HEC169096 as determined during Phase 2.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Phase 1:Pathologically documented, definitively diagnosed non-resectable advanced solid tumor. * Phase 2: All participants must have an oncogenic RET-rearrangement/fusion or mutation (excluding synonymous, frameshift, and nonsense mutations) solid tumor. * Participants has Eas...

Countries:China
Unlock Eligibility Criteria

Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Solid Tumor")

Recent Changes (Last 90 Days)

LOWJul 5, 2026NCT05451602primaryCompletionDate: changed
LOWJul 5, 2026NCT05451602primaryCompletionDate: changed
LOWJul 5, 2026NCT05451602primaryCompletionDate: changed

Frequently asked questions about HEC169096

What is HEC169096 used for?

HEC169096 is an investigational small molecule being studied for the treatment of advanced solid tumors. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in patients with advanced solid tumors to assess its safety and potential efficacy.

What does HEC169096 target?

The specific molecular target of HEC169096 has not been disclosed. It is a small molecule therapeutic being developed for oncology, specifically for advanced solid tumors. The mechanism of action is not publicly detailed, and the drug is currently in early-stage clinical trials to determine its effects.

Who makes HEC169096?

HEC169096 is being developed by Sunshine Biopharma Inc., a biopharmaceutical company traded on the stock market under the ticker symbol SBFM. The company is conducting clinical research on this investigational drug for the treatment of advanced solid tumors.

What phase is HEC169096 in?

HEC169096 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by regulatory agencies. The ongoing Phase 1 trial is recruiting participants to evaluate the drug's safety, tolerability, and pharmacokinetics in patients with advanced solid tumors.

What clinical trials is HEC169096 in?

HEC169096 is being studied in a Phase 1 clinical trial registered as NCT05451602, titled 'HEC169096 in Participants With Advanced Solid Tumors.' The trial is recruiting 456 participants in China, with an age minimum of 18 years, and is open to all sexes. It is an uncontrolled, non-randomized study.

Is HEC169096 the same as any other drug?

No alternative names for HEC169096 have been reported. It is a distinct investigational compound developed by Sunshine Biopharma Inc. and is not known to be identical to any other marketed or investigational drug.