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HEC68498 · 2 trials · 2 indications
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
To assess the safety and tolerability of single dose administered
| Arm | Type | Description |
|---|---|---|
| HEC68498 | EXPERIMENTAL | HEC68498 will be administered daily |
| placebo | PLACEBO_COMPARATOR | administered once on first day in each Treatment Period |
| Name | Type | Description |
|---|---|---|
| HEC68498 | DRUG | HEC68498 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. |
| HEC 68498 | DRUG | HEC68498 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. |
| Placebo | DRUG | Placebo |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE2 | Pembrolizumab, Gardasil 9 |
| Incyte Corporation | INCY | 1 | PHASE2 | Retifanlimab |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE1 | KFA115 |
| Iovance Biotherapeutics Inc | IOVA | 2 | PHASE2 | Aldesleukin |
| AstraZeneca PLC | AZN | 1 | - | Trastuzumab deruxtecan |
HEC68498 is an investigational small molecule developed by Sunshine Biopharma Inc. (ticker SBFM). It is being studied in Phase 1 clinical development for advanced refractory solid tumors and idiopathic pulmonary fibrosis. It is a biomarker-selected therapy, meaning trial enrollment has been guided by biomarker criteria.
HEC68498 is being developed for two indications: advanced refractory solid tumors, which fall within oncology, and idiopathic pulmonary fibrosis. Both are Phase 1 stage programs. The drug is investigational and has not been approved for any use.
HEC68498 is developed by Sunshine Biopharma Inc., which trades under the ticker SBFM. The company is the sponsor behind the clinical program for the drug across its oncology and idiopathic pulmonary fibrosis indications.
HEC68498 is in Phase 1 clinical development. It is an investigational small molecule and is not approved by the FDA. Two Phase 1 studies have been completed, one in advanced refractory solid tumors and one in healthy volunteers.
HEC68498 has been studied in two completed Phase 1 trials. NCT04324372 evaluated HEC68498 in patients with advanced refractory solid tumors in China with 12 participants. NCT03502902 was a safety, tolerability and pharmacokinetic study in healthy male and female subjects in the United States with 55 participants.
Yes, HEC68498 and HEC 68498 refer to the same investigational drug. The spelling with a space is an alternative way of writing the compound name used by Sunshine Biopharma Inc. (ticker SBFM). Searches for either form point to the same Phase 1 small molecule program.