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KVA12123- Dose Escalation

Phase 1

Cancer | Small molecule | Oncology |TuHURA Biosciences, Inc.|Last Updated: Jun 18, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

KVA12123- Dose Escalation · 1 trial · 17 indications

Phase 1 1
NCT05708950A Clinical Trial of KVA12123 [TBS-2025] Treatment Alone and in Combination With Pembrolizumab In Advanced Solid Tumors (VISTA-101)Cancer
COMPLETED40 Analytics
PHASE1COMPLETED
A Clinical Trial of KVA12123 [TBS-2025] Treatment Alone and in Combination With Pembrolizumab In Advanced Solid Tumors (VISTA-101)
CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Adverse Events
Through study completion, an average of 1 year

Type and frequency of adverse events as assessed by CTCAE v4.0.

AEs related to study drug
Through study completion, an average of 1 year

Type and frequency of treatment related adverse events as assessed by CTCAE v4.0.

Recommended Phase 2 dose (RP2D) or maximum tolerated dose (MTD)
Through study completion, an average of 1 year

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).

Secondary Endpoints

Pharmacokinetic (PK) profile of KVA12123 (Cmax)
Through study completion, an average of 1 year
Pharmacokinetic (PK) profile of KVA12123 (Cmin)
Through study completion, an average of 1 year
Pharmacokinetic (PK) profile of KVA12123 (tmax)
Through study completion, an average of 1 year
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
KVA12123 Monotherapy Dose EscalationEXPERIMENTALPart A will consist of dose escalation with KVA12123 administered as a single agent in participants with advanced solid tumors.
KVA12123 Plus Pembrolizumab Dose EscalationEXPERIMENTALPart B will consist of dose escalation with KVA12123 administered in combination with a fixed dose of pembrolizumab.
KVA12123 Monotherapy Dose ExpansionEXPERIMENTALPart C will consist of dose expansion with KVA12123 administered as a single agent at the RP2D in participants with advanced solid tumors.
KVA12123 Plus Pembrolizumab Dose ExpansionEXPERIMENTALPart D will consist of dose expansion with KVA12123 administered at the RP2D in combination with a fixed dose of pembrolizumab.

Interventions

NameTypeDescription
KVA12123 - Dose EscalationDRUGAscending KVA12123 doses given as monotherapy by intravenous administration every 2 weeks of each 6-week cycle.
KVA12123 Plus Pembrolizumab - Dose EscalationDRUGAscending 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 ExpansionDRUGKVA12123 administered at the RP2D by intravenous administration every 2 weeks of each 6 week cycle.
KVA12123 Plus Pembrolizumab - Dose ExpansionDRUGKVA12123 administered at the RP2D by intravenous administration every 2 weeks in combination with a fixed dose of pembrolizumab administered once every 6 week cycle.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites7

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...

Countries:United States
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Frequently asked questions about KVA12123- Dose Escalation

What is KVA12123 used for?

KVA12123 is an investigational small molecule being studied for the treatment of advanced solid tumors, including melanoma, carcinoma, sarcoma, lung, prostate, breast, colorectal, uterine, pancreatic, gastric, esophageal, thyroid, ovarian, kidney, and head and neck cancers. It is currently in Phase 1 clinical development.

How does KVA12123 work?

KVA12123 is a small molecule designed to treat cancer. Its specific molecular target has not been disclosed. The drug is being evaluated alone and in combination with pembrolizumab in patients with advanced solid tumors.

Who is developing KVA12123?

KVA12123 is being developed by TuHURA Biosciences, Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with advanced solid tumors.

What phase is KVA12123 in?

KVA12123 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug is being studied for safety, tolerability, and preliminary efficacy in patients with advanced solid tumors.

What clinical trials is KVA12123 in?

KVA12123 is being studied in a Phase 1 clinical trial with the identifier NCT05708950. This trial, known as VISTA-101, evaluates KVA12123 alone and in combination with pembrolizumab in patients with advanced solid tumors. The trial has been completed and enrolled 40 participants.

Is KVA12123 the same as TBS-2025?

Yes, KVA12123 is also known as TBS-2025. The clinical trial NCT05708950 is titled "A Clinical Trial of KVA12123 [TBS-2025] Treatment Alone and in Combination With Pembrolizumab In Advanced Solid Tumors (VISTA-101)."