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 is an investigational small molecule being studied for the treatment of non-small cell lung cancer, specifically advanced or metastatic NSCLC. It is being developed as a later-line treatment option for patients with this type of lung cancer.
6-Thio-2'-Deoxyguanosine is being developed by MAIA Biotechnology, Inc., which trades under the ticker MAIA. The company is the sponsor advancing the compound through clinical development for non-small cell lung cancer.
6-Thio-2'-Deoxyguanosine is in Phase 3 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 3 program is evaluating the drug in advanced or metastatic non-small cell lung cancer.
6-Thio-2'-Deoxyguanosine is being studied in two clinical trials. NCT06908304 is a Phase 3 study evaluating THIO plus cemiplimab versus chemotherapy as third-line treatment in advanced or metastatic NSCLC. NCT05208944 is a Phase 2 study of THIO sequenced with cemiplimab in advanced NSCLC.
6-Thio-2'-Deoxyguanosine has received Orphan Drug and Rare Pediatric Disease designations from the FDA. These designations are separate from approval status, and the compound remains investigational and in clinical development for non-small cell lung cancer.
The 6-Thio-2'-Deoxyguanosine clinical program has a total planned enrollment of 527 patients across two trials. The Phase 3 trial NCT06908304 plans to enroll 300 patients, and the Phase 2 trial NCT05208944 has an enrollment of 227 patients.