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HEC68498

Phase 1

Advanced Refractory Solid Tumors | Small molecule | Oncology |Sunshine Biopharma Inc.|Last Updated: Aug 12, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

HEC68498 · 1 trial · 1 indication

Phase 1 1
NCT04324372Clinical Study of HEC68498 in Patients With Advanced Refractory Solid TumorsAdvanced Refractory Solid Tumors
COMPLETED12 Analytics
PHASE1COMPLETED
Clinical Study of HEC68498 in Patients With Advanced Refractory Solid Tumors
Advanced Refractory Solid TumorsUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum tolerated dose
28 days

Patients will receive study drug on a daily basis for 28 days according to the dose and schedule specified for a particular cohort of therapy. Toxicities observed in Cycle 0\&1 will be considered for dose limiting toxicity (DLT) and Maximum tolerated dose (MTD)determination

Secondary Endpoints

Number of subject with adverse events
up to 4 weeks after last dose
Objective response
up to approximately 24 months
AUC0-∞
up to approximately 4 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
HEC68498EXPERIMENTALHEC68498 will be administered daily

Interventions

NameTypeDescription
HEC68498DRUGHEC68498 is a potent,highly selective inhibitor of class 1 isozymes of phosphoinositide 3-kinase/mammalian(PI3K) and of the mammalian target of rapamycin (mTOR). It has shown good activity against fibrosis and inflammation in vitro and in vivo, with a lower effective dose and better efficacy than pirfenidone and nintedanib.
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: (1)Target subjects 1. 18 years of age ≤ age ≤ 70 years of age, regardless of gender; 2. Patients with various types of advanced solid tumors confirmed by cytological or histological examination. Dose escalation test phase: including breast cancer, colorectal cancer, neuroen...

Countries:China
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Competitive Landscape -Other Solid Tumors 9 trials (matched to "Advanced Refractory Solid Tumors")

Frequently asked questions about HEC68498

What is HEC 68498 used for?

HEC 68498 is an investigational small molecule being studied for Idiopathic Pulmonary Fibrosis and Advanced Refractory Solid Tumors. It is currently in Phase 1 clinical development and has not been approved by the FDA.

Who makes HEC 68498?

HEC 68498 is being developed by Sunshine Biopharma Inc., a company listed on the stock exchange under the ticker SBFM.

What phase is HEC 68498 in?

HEC 68498 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials are ongoing to evaluate its safety and tolerability.

What clinical trials is HEC 68498 in?

HEC 68498 has been studied in two completed Phase 1 trials. NCT03502902 evaluated safety, tolerability, and pharmacokinetics in healthy volunteers with Idiopathic Pulmonary Fibrosis. NCT04324372 studied the drug in patients with Advanced Refractory Solid Tumors.

Is HEC 68498 the same as HEC68498?

Yes, HEC 68498 is the same drug as HEC68498. The name is sometimes written with or without a space, but it refers to the same investigational small molecule being developed by Sunshine Biopharma Inc.