Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
KVA12123 · 1 trial · 17 indications
Type and frequency of adverse events as assessed by CTCAE v5.0.
Type and frequency of treatment related adverse events as assessed by CTCAE v4.0.
Recommended Phase 2 dose (RP2D) or maximum tolerated dose (MTD) of KVA12123 when administered alone and in combination with pembrolizumab in participants with advanced solid tumors (milligrams or milligrams/kilogram).
| Arm | Type | Description |
|---|---|---|
| KVA12123 [TBS-2025] Monotherapy Dose Escalation | EXPERIMENTAL | Part A will consist of dose escalation with KVA12123 \[TBS-2025\] administered as a single agent in participants with advanced solid tumors. |
| KVA12123 [TBS-2025] Plus Pembrolizumab Dose Escalation | EXPERIMENTAL | Part B will consist of dose escalation with KVA12123 administered in combination with a fixed dose of pembrolizumab. |
| KVA12123 [TBS-2025] Monotherapy Dose Expansion | EXPERIMENTAL | Part C will consist of dose expansion with KVA12123 \[TBS-2025\] administered as a single agent at the RP2D in participants with advanced solid tumors. Part C was not initiated. |
| KVA12123 Plus Pembrolizumab Dose Expansion | EXPERIMENTAL | Part D will consist of dose expansion with KVA12123 \[TBS-2025\] administered at the RP2D in combination with a fixed dose of pembrolizumab. Part D was not initiated. |
| Name | Type | Description |
|---|---|---|
| KVA12123 - Dose Escalation | DRUG | Ascending KVA12123 doses given as monotherapy by intravenous administration every 2 weeks of each 6-week cycle. |
| KVA12123 Plus Pembrolizumab - Dose Escalation | DRUG | Ascending KVA12123 doses given by intravenous administration every 2 weeks of each 6-week cycle in combination with a fixed dose of pembrolizumab administered once every 6 week cycle. |
| KVA12123 - Dose Expansion | DRUG | KVA12123 administered at the RP2D by intravenous administration every 2 weeks of each 6 week cycle. |
| KVA12123 Plus Pembrolizumab - Dose Expansion | DRUG | KVA12123 administered at the RP2D by intravenous administration every 2 weeks in combination with a fixed dose of pembrolizumab administered once every 6 week cycle. |
Inclusion Criteria 1. Willing and able to provide informed consent. 2. Be at least 18 years of age at the time of consent. 3. Has histologically or cytologically confirmed, locally advanced or metastatic solid tumor that has progressed or was non-responsive to standard of care therapy and for which...
Top 2 of 4 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| GE Healthcare Technologies Inc. | GEHC | 1 | PHASE1 | GEH200520/GEH200521 |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | Olverembatinib |
KVA12123 is an investigational small molecule cancer therapy developed by TuHURA Biosciences, Inc. It was studied in a Phase 1 dose escalation trial in patients with advanced solid tumors, both as a single agent and in combination with pembrolizumab. It is not approved and remains in clinical development.
KVA12123 was evaluated for the treatment of advanced solid tumors. The Phase 1 VISTA-101 trial enrolled patients with a range of tumor types, including melanoma, lung, prostate, breast, colorectal, pancreatic, ovarian, kidney, head and neck, gastric, esophageal, thyroid, uterine, and other cancers.
KVA12123 is being developed by TuHURA Biosciences, Inc., which trades under the ticker HURA. The company sponsored the Phase 1 VISTA-101 trial of the agent in advanced solid tumors.
KVA12123 is in Phase 1 clinical development. Its single registered trial, VISTA-101, was a Phase 1 dose escalation study that has been completed. The drug is investigational and has not been approved for any indication.
KVA12123 was studied in one clinical trial, NCT05708950, also called VISTA-101. This completed Phase 1 trial enrolled 40 patients with advanced solid tumors in the United States and tested KVA12123 alone and in combination with pembrolizumab. It was a controlled, randomized trial without double blinding.
Yes. KVA12123 is also known as TBS-2025, and the two names refer to the same investigational agent. The Phase 1 VISTA-101 trial is listed under the title referencing KVA12123 [TBS-2025], confirming they are the same small molecule being developed by TuHURA Biosciences.