Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AFNT-211 · 1 trial · 5 indications
Quantify the desirability of a dose in terms of toxicity-efficacy tradeoff during the dose escalation portion of the study
This will be selected based on Bayesian optimal interval Phase I/II (BOIN12) design recommendation and the totality of benefit-risk evidence during dose escalation
The incidence of TEAEs will be used to determine safety and tolerability of AFNT-211
The incidence of SAEs will be used to determine safety and tolerability of AFNT-211
The incidence of DLTs during Dose Escalation will be used to determine safety and tolerability of AFNT-211
| Arm | Type | Description |
|---|---|---|
| Dose Escalation | EXPERIMENTAL | Subjects will be given a one-time infusion of AFNT-211 starting at dose level 1 and monitored for 28 days (DLT period). Each cohort will enroll 2-4 subjects at different dose levels for a total of 20 subjects in the escalation portion. The optimal biological dose and recommended phase 2 dose will be determined. |
| Dose Expansion: PDAC | EXPERIMENTAL | 20 subjects with pancreatic ductal adenocarcinoma will be given a one-time infusion of AFNT-211 at the optimal biological dose / recommended phase 2 dose determined in the escalation portion. Subjects will be monitored for safety for 28 days. |
| Dose Expansion: CRC | EXPERIMENTAL | 20 subjects with colorectal carcinoma will be given a one-time infusion of AFNT-211 at the optimal biological dose / recommended phase 2 dose determined in the escalation portion. Subjects will be monitored for safety for 28 days. |
| Dose Expansion: NSCLC | EXPERIMENTAL | 20 subjects with non-small cell cancer will be given a one-time infusion of AFNT-211 at the optimal biological dose / recommended phase 2 dose determined in the escalation portion. Subjects will be monitored for safety for 28 days. |
| Dose Expansion: Adv Solid Tumors | EXPERIMENTAL | 20 subjects with solid tumors will be given a one-time infusion of AFNT-211 at the optimal biological dose / recommended phase 2 dose determined in the escalation portion. Subjects will be monitored for safety for 28 days. |
| Name | Type | Description |
|---|---|---|
| AFNT-211 | DRUG | Engineered TCR T-Cell |
Key Inclusion Criteria: 1. Confirmed KRAS G12V mutational status and HLA-A\*11:01 allele 2. Histologically confirmed advanced or metastatic, unresectable solid tumor 3. Progressed on or intolerant of at least one prior line of standard systemic therapy for the current malignancy. 4. Measurable dise...
AFNT-211 is an investigational small molecule being developed for the treatment of pancreatic ductal adenocarcinoma, a type of pancreatic cancer. It is currently in Phase 1 clinical development and is being studied in patients with advanced or metastatic solid tumors, including pancreatic ductal adenocarcinoma.
AFNT-211 is designed to target the KRAS G12V mutation, a specific genetic alteration found in certain solid tumors. The drug is being evaluated in a biomarker-selected patient population, meaning that patients are chosen based on the presence of this specific mutation.
AFNT-211 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in patients with advanced or metastatic solid tumors.
AFNT-211 is currently in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is designed to assess the safety, tolerability, and preliminary efficacy of AFNT-211 in patients with certain solid tumors.
AFNT-211 is being studied in a Phase 1 clinical trial registered as NCT06105021. This trial is titled 'Phase I Study of Autologous CD8+ and CD4+ Engineered T Cell Receptor T Cells in Subjects With Advanced or Metastatic Solid Tumor' and is currently active but not recruiting participants.
AFNT-211 is a small molecule drug, not an engineered T cell therapy. However, the clinical trial NCT06105021, which is studying AFNT-211, involves autologous CD8+ and CD4+ engineered T cell receptor T cells. This indicates that the trial is evaluating a combination or comparison of AFNT-211 with T cell therapy.