Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
6-Thio-2'-Deoxyguanosine · 2 trials · 2 indications
Overall survival as defined as the time from randomization to death from any cause.
Part A: Incidence of DLTs
ORR, defined as the proportion of subjects with either a CR or PR, as assessed by the investigator based on RECIST v1.1
| Arm | Type | Description |
|---|---|---|
| THIO + Cemiplimab Arm | EXPERIMENTAL | THIO 60mg, 30-min IV infusions, Days 1-3 (180 mg/Cycle) Cemplimab 350 mg, 30-min IV infusion, Day 5 3-Week Cycle |
| Investigator's choice of single-agent chemotherapy (vinorelbine, gemcitabine, or docetaxel) | ACTIVE_COMPARATOR | Chemotherapy Agent \[1\] Dosing Regimen No. of Subjects (Planned) Option 1: Vinorelbine 30 mg/m2 IV on D1, D8, and D15 Q3W \~150 \[3\] Option 2: Gemcitabine 1250 mg/m2 IV on D1 and D8 Q3W Option 3: Docetaxel 75 mg/m2 IV on D1 Q3W \[2\] Abbreviations: D = day (within a 21-day cycle); IV= intravenous; Q3W=every 3 weeks (21-day cycles) 1. Standard of Care (for example vinorelbine, gemcitabine, or docetaxel chemotherapy, if not previously exposed, per Investigator's Choice) 2. Docetaxel 60-65 mg/m2 permitted based on country-specific approvals. 3. Within the control arm, there are no limits on the number of subjects who can be treated with any of the chemotherapy agents. |
| Part A | EXPERIMENTAL | Safety lead-in, modified 3+3 design. Part A: Cohort 1: THIO total 360 mg per cycle (120 mg on Days 1-3 Q3W) plus 350 mg cemiplimab on Day 5; Cohort 2 (pending emerging data from Cohort 1): THIO total 180 mg per cycle (60 mg on Days 1-3 Q3W) plus 350 mg cemiplimab on Day 5 |
| Part B | EXPERIMENTAL | Cohort 1: THIO total 60 mg per cycle (20 mg on D1-3 Q3W) plus 350 mg cemiplimab on Day 5; Cohort 2: THIO total 180 mg per cycle (60 mg on D1-3 Q3W) plus 350 mg cemiplimab on Day 5; Cohort 3 (pending emerging data from Part A): THIO total 360 mg per cycle (120 mg on Days 1-3 Q3W) plus 350 mg cemiplimab on Day 5 |
| Part C | EXPERIMENTAL | To obtain clinical evidence of the efficacy and safety of the sequential combination of THIO 180 mg per cycle plus cemiplimab compared to single-agent THIO 180 mg per cycle as third-line treatment in subjects with advanced/metastatic NSCLC. |
| Part D | EXPERIMENTAL | To determine the efficacy of THIO 180 mg per cycle (60 mg on Days 1-3, sequenced with cemiplimab) when administered as third-line treatment in subjects with advanced/metastatic NSCLC. |
| Name | Type | Description |
|---|---|---|
| 6-Thio-2'-Deoxyguanosine | DRUG | small molecule telomere targeting agent |
| Cemiplimab | DRUG | programmed cell death protein 1 (PD-1) inhibitor |
| Docetaxel | DRUG | Chemotherapy drug; inhibits cell division by stabilizing microtubules. Used for breast, lung, and prostate cancers. |
| Vinorelbine | DRUG | Chemotherapy drug; disrupts microtubule formation, inhibiting cell division. Used for non-small cell lung cancer and breast cancer. |
| Gemcitabine alone | DRUG | Chemotherapy drug; inhibits DNA synthesis. Used for pancreatic, lung, breast, and ovarian cancers. |
Inclusion Criteria: 1. At least 18 years of age at the time of signing the Informed Consent Form (ICF) prior to initiation of any study specific activities/procedures. Disease Characteristics 2. Stage 3b or 4 histologically or cytologically confirmed NSCLC. Note: Stage is determined at the time...
6-Thio-2'-Deoxyguanosine, also known as THIO, is an investigational small molecule being developed for the treatment of non-small-cell lung carcinoma (NSCLC). It is currently in Phase 3 clinical development for advanced or metastatic NSCLC as a third-line treatment, administered in combination with cemiplimab.
6-Thio-2'-Deoxyguanosine is being developed by MAIA Biotechnology, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol MAIA. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with non-small-cell lung carcinoma.
6-Thio-2'-Deoxyguanosine is currently in Phase 3 clinical development. A Phase 3 study (NCT06908304) is recruiting patients to evaluate the drug in combination with cemiplimab versus chemotherapy as a third-line treatment for advanced or metastatic non-small-cell lung carcinoma. The drug is investigational and not yet approved.
6-Thio-2'-Deoxyguanosine is being studied in two clinical trials. NCT05208944 is a Phase 2 study of THIO sequenced with cemiplimab in advanced non-small-cell lung carcinoma, which is active but not recruiting. NCT06908304 is a Phase 3 study of THIO plus cemiplimab versus chemotherapy as third-line treatment in advanced or metastatic NSCLC, which is currently recruiting.
Yes, 6-Thio-2'-Deoxyguanosine is also known as THIO. In clinical trials, the drug is referred to as THIO, and it is being investigated in combination with cemiplimab for the treatment of non-small-cell lung carcinoma. The drug has received orphan drug designation and rare pediatric disease designation from the FDA.