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Also known as vilastobart (XTX101)
vilastobart · 2 trials · 2 indications
The primary endpoint is objective response rate for combination of vilastobart with retifanlimab. Response is measured using RECISTv1.1 and evaluated independently. Evaluation of the primary endpoint will follow a Simon's two-stage design. The objective response rate will be reported with an exact binomial 95% confidence interval.
| Arm | Type | Description |
|---|---|---|
| Vilastobart + Retifanlimab | EXPERIMENTAL | This arm involves screening, study treatment with the study drugs, study visits, and follow-up visits for up to 3 years from time of joining study. Participants will receive up to 4 doses of Vilastobart, and Retifanlimab every three weeks until disease progression, intolerable side effects, or for a total of one year. Premedication for all vilastobart doses is required. For participants who experience disease progression on retifanlimab monotherapy or after completion of therapy on trial may be considered for re-induction with vilastobart and retifanlimab. Treatment beyond disease progression will be permitted for first instance of progressive disease by RECIST only if patients remain clinically stable from their disease and ongoing treatment is considered appropriate by patient, treating physician, and Sponsor Investigator. |
| Part 1A - vilastobart (XTX101) Monotherapy Dose Escalation | EXPERIMENTAL | Part 1A Dose Escalation of vilastobart (XTX101) administered in ascending doses to patients with advanced or metastatic solid tumors to find the recommended phase 2 dose (RP2D). |
| Part 1B - Pharmacodynamic (PD) Dose Expansion | EXPERIMENTAL | Part 1B vilastobart (XTX101) at the RP2D will be administered to further examine vilastobart (XTX101) as monotherapy in patients with select advanced solid tumors. |
| Part 1C - vilastobart (XTX101) Dose Escalation and Dose Expansion in Combination with Atezolizumab | EXPERIMENTAL | Part 1C will receive a labeled dose of atezolizumab in combination with vilastobart (XTX101). |
| Phase 2 - vilastobart (XTX101) Dose Expansion in Combination with Atezolizumab | EXPERIMENTAL | Phase 2 will receive a labeled dose of atezolizumab in combination with vilastobart (XTX101) at the RP2D(s) in patients with MSS CRC. |
| Name | Type | Description |
|---|---|---|
| vilastobart (XTX101) | DRUG | 100mg administered once every 6 weeks (Day 1 of every 6-week cycle) by intravenous infusion (IV) over about 90-140 minutes. This will continue for up to 4 6-week cycles (4 doses). |
| Retifanlimab | DRUG | 375 mg administered once every 3 weeks (Days 2 and 23 of every 6-week cycle) by intravenous infusion over about 30 minutes. This will continue for up to 12 months. |
| Atezolizumab | DRUG | 1200 mg administered every 3 weeks in combination with vilastobart (XTX101) |
Inclusion Criteria: * Participant must have histologically proven metastatic pancreatic cancer. Histologies including acinar cell carcinoma, carcinoma, ductal carcinoma, ductal adenocarcinoma, poorly differentiated or adenosquamous carcinoma are allowed. * Participant must have a germline or somati...
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Vilastobart is an investigational oncology drug being studied for the treatment of advanced solid tumors and metastatic pancreatic cancer. It is currently in clinical development for these indications.
Vilastobart targets CTLA-4, a protein involved in regulating immune responses. By targeting CTLA-4, vilastobart is designed to modulate the immune system's ability to fight cancer cells.
Vilastobart is being developed by Xilio Therapeutics, Inc., a biopharmaceutical company. Xilio Therapeutics is publicly traded under the ticker symbol XLO.
Vilastobart is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities for any use.
Vilastobart has been studied in a Phase 1 trial (NCT04896697) for advanced solid tumors, which has been completed. A Phase 2 trial (NCT07765836) is planned for metastatic pancreatic cancer in patients with BRCA or PALB2 deficiencies.
Yes, vilastobart is also known as XTX101. Both names refer to the same investigational drug being developed by Xilio Therapeutics.