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RSC-1255 Dose Escalation · 1 trial · 6 indications
The number and type of dose-limiting toxicities (DLTs) as defined in the protocol that occur during the first 21 days of treatment and maximum grade of all treatment-related events using CTCAE V5.0 will be used to identify a safe and tolerable dose.
The number and type of DLTs as defined in the protocol that occur during the first 21 days of treatment and maximum grade of all treatment-related adverse events using CTCAE 5.0 will be used to identify a safe and tolerable dose.
| Arm | Type | Description |
|---|---|---|
| RSC-1255 Treatment | EXPERIMENTAL | Single Arm Study. All study participants receive RSC-1255. |
| Name | Type | Description |
|---|---|---|
| RSC-1255 Dose Escalation | DRUG | Phase 1a will enroll 40-80 participants to identify the dose limiting toxicity (DLT), recommended Phase 1b dose, and the safety and tolerability of RSC-1255. RSC-1255 is administered orally twice daily, with and without food. Each cycle is 21 days. |
| RSC-1255 Dose Expansion | DRUG | Phase 1b will enroll 48-94 participants to further characterize the safety, pharmacology, and clinical efficacy of RSC-1255. RSC-1255 is administered orally twice daily alone or in combination with continuous hydroxychloroquine, with food. Each cycle is 21 days. |
Inclusion Criteria (Key Factors): 1. Has pathologically confirmed advanced or metastatic malignancy characterized by one or more of the following: * Participant is intolerant of existing therapy(ies) known to provide clinical benefit for their condition * Malignancy is refractory to existing...
RSC-1255 is an investigational small molecule being studied for the treatment of advanced malignant solid neoplasms, including RAS-mutated cancers such as lung cancer, colon cancer, glioblastoma, and pancreatic cancer. It is currently in Phase 1 clinical development and has not been approved by the FDA.
RSC-1255 is a small molecule being studied in patients with RAS mutations, indicating it targets the RAS signaling pathway. The drug is being evaluated in a biomarker-selected trial for advanced solid tumors with RAS mutations, including lung, colon, and pancreatic cancers.
RSC-1255 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker YCBD. The drug is currently in Phase 1 clinical trials for advanced malignant solid neoplasms.
RSC-1255 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is recruiting patients with advanced malignancies.
RSC-1255 is being studied in a Phase 1 clinical trial with the identifier NCT04678648, titled 'A Trial of RSC-1255 for Treatment of Patients With Advanced Malignancies.' The trial is recruiting in the United States and has a planned enrollment of 134 participants.