CancerPhase 1/2NCT05708950
A Clinical Trial of KVA12123 [TBS-2025] Treatment Alone and in Combination With Pembrolizumab In Advanced Solid Tumors (VISTA-101)
A Phase 1/2 study testing KVA12123 - Dose Escalation, KVA12123 Plus Pembrolizumab - Dose Escalation and KVA12123 - Dose Expansion in people with Cancer and Solid Tumor, run by Kineta Inc. at 7 sites in United States.
Trial summary
This clinical trial evaluated the safety and efficacy of KVA12123, subsequently designated TBS-2025, alone or combined with pembrolizumab in patients with advanced solid tumors. The study included dose escalation and planned dose expansion phases. Only the dose escalation phases were conducted. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Solid Tumor, Melanoma
- What is being tested?
- KVA12123 - Dose Escalation, KVA12123 Plus Pembrolizumab - Dose Escalation and KVA12123 - Dose Expansion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 7 sitesUnited States
- Study dates
- 3 Mar 2023to 18 Dec 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide informed consent.
- Be at least 18 years of age at the time of consent.
- 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 no available curative therapy exists.
- Has expected survival ≥16 weeks.
- Presence of measurable disease by iRECIST.
- Has an ECOG performance status score of 0 or 1.
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- Has adequate organ function within 10 days prior to the start of study treatment.
- Has normal thyroid function or hypothyroid with stable supplementation.
- Has consented to the collection of archival tissue prior to study treatment initiation.
- Participants with prior exposure to systemic anticancer therapy including investigational agents following a 4-week washout period are eligible. Participants with prior small molecule targeted therapy or other short half-life drugs are eligible following a 2-week washout period.
- Participants having prior curative radiation therapy completed 2 weeks prior to study drug administration or prior palliative radiation therapy to non-CNS disease completed at least 1 week prior to study drug administration are eligible.
- HIV-infected participants must be on anti-retroviral therapy (ART) and have a well-controlled HIV infection/disease.
- Participants with a history of HBV infection having durable HBsAg loss and undetectable serum HBV DNA no longer requiring treatment are eligible.
- Participants with history of HCV infection are eligible if HCV viral load is undetectable at screening and participants have completed curative antiviral therapy.
- Post-menopausal women and surgically sterile men and women are permitted.
- Patients of childbearing potential are permitted to participate under the following conditions:
- Must have negative urine pregnancy test result within 72 hrs prior to the first dose of any study drug
- Must agree not to become pregnant during the study and for 120 days after the final dose of any study drug
- Must agree not to breastfeed or donate ova, starting at time of informed consent and continuing through 120 days after the final dose of any study drug
- If sexually active in a way that could lead to pregnancy, must consistently use 2 acceptable methods of birth control (contraception), at least 1 of which must be highly effective starting at time of informed consent and continuing throughout the study and for 120 days after the final dose of any study drug.
- Patients who can father children are permitted to participate under the following conditions:
- Must agree not to donate sperm starting at the time of informed consent and continuing throughout the study period and for 120 days after the final dose of any study drug
- If sexually active with a person of childbearing potential in a way that could lead to pregnancy, must consistently use 2 acceptable methods of birth control (contraception), at least 1 of which must be highly effective starting at the time of informed consent and continuing throughout the study and for 120 days after the final dose of any study drug
- If sexually active with a person who is pregnant or breastfeeding, must consistently use a condom starting at time of informed consent and continuing throughout the study and for 120 days after the final dose of any study drug.
- Must be willing and able to comply with the trial procedures and the follow-up schedule.
Who cannot join
- Untreated CNS metastatic disease, leptomeningeal disease, or cord compression.
- Concurrent cancer other than disease under study requiring systemic treatment. Participants with basal cell or squamous cell skin cancer treated with curative intent, carcinoma in-situ of the cervix or breast treated with curative intent, RAI stage 0 Chronic Lymphocytic Leukemia, monoclonal gammopathy of undetermined significance, superficial bladder cancer or very low and low risk prostate cancer (localized Gleason score ≤ 6) under active surveillance are eligible.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg QD of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
- History of (non-infectious) pneumonitis/interstitial lung disease (ILD) that required steroids or current pneumonitis/ILD.
- Prior treatment with VISTA-targeted therapy.
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- Prior history of allogeneic, solid organ or stem cell transplant, or adoptive T-cell transplant.
- Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, LAG-3, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-related adverse event (irAE).
- Active known or suspected autoimmune disease that has required systemic treatment within the past year. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Prior systemic anticancer therapy, including investigational agents, within 4 weeks of treatment. Participants with prior small molecule targeted therapy or other short half-life drugs are eligible following a 2-week washout period.
- Has received prior radiation therapy within 2 weeks of start of study treatment or has a history of radiation pneumonitis.
- Has received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study treatment.
- Has received a live or live-attenuated vaccine within 30 days prior to the first dose of study intervention.
- Any requirement for daily supplemental oxygen.
- Any condition requiring systemic treatment with corticosteroids (>10 mg QD prednisone equivalents) or other immunosuppressive medications within 14 days before the first dose of study drug.
- Serious or poorly controlled cardiovascular disease.
- Chronic hepatitis B or C.
- HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
- Has an active infection requiring systemic therapy.
- Known active or latent tuberculosis.
- If the participant had major surgery, must have recovered adequately from the procedure and/or any complications.
- Toxicities arising from prior cancer therapy that have not resolved to Grade 1 or baseline.
- Red blood cell or platelet infusion within the preceding 2 weeks.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- Known hypersensitivity to any excipient contained in the drug formulation of KVA12123.
- Any significant history of drug allergy as assessed by the investigator.
- Positive urine pregnancy test within 72 hrs of study drug administration.
- Participants who are breastfeeding, pregnant, or planning to become pregnant from time of informed consent until at least 120 days after final dose of study drug.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study.
- Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.
- Inability to comply with study procedures.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
University of Michigan
Ann Arbor, Michigan, 48109
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
Sarah Cannon Research Institute at Tennessee Oncology
Nashville, Tennessee, 37203
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
UCLA Health (Santa Monica Cancer Care)
Santa Monica, California, 90404
Sarah Cannon Research Institute at Florida Cancer Specialists
Sarasota, Florida, 34232
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
About this study
Official title: A Phase 1/2 Open-label Trial of KVA12123 [TBS-2025] Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
This clinical trial evaluated the safety and efficacy of KVA12123, subsequently designated TBS-2025, alone or combined with pembrolizumab in patients with advanced solid tumors. The study included dose escalation and planned dose expansion phases. Only the dose escalation phases were conducted. The planned dose expansion phase were not initiated following a business decision to discontinue development in solid tumors. This decision was unrelated to any identified safety concern.
The study sought to assess the safety of KVA12123 [TBS-2025] given alone or with pembrolizumab and to identify appropriate doses for future clinical trials. Participants in the doses for future clinical trials. Participants in the dose escalation phases visited study sites for treatment and safety assessments. These assessments included blood samples, imaging scans, physical examinations, and heart function tests.
Read the detailed description
This was a first-in-human (FIH), Phase 1/2, open-label, multicenter, dose escalation, and dose expansion study designed to evaluate the safety, tolerability, PK, immunogenicity, and tumor response of the investigational drug KVA12123, subsequently designated TBS-2025, alone and in combination with pembrolizumab in adults with relapsed or refractory advanced solid tumors. The study was planned to conduct in 4 planned parts: Parts A and B focus on dose escalation (single-agent and in combination), and Parts C and D focus on dose expansion (single-agent and in combination).
Parts A (single-agent KVA12123) and B (KVA12123 + pembrolizumab) allowed up to 10 dose escalation cohorts: 6 in Part A and 4 in Part B, with 1 to 6 participants per cohorts. These parts were intended to characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary tumor response, and to inform the selection of recommended phase 2 doses.
Parts C (single-agent KVA12123) and D (KVA12123 + pembrolizumab) were planned but not initiated following a business decision to discontinue development in solid tumors. This decision was unrelated to any identified safety concern.
- Conditions
- Cancer, Solid Tumor, Melanoma, Carcinoma, Sarcoma, Lung Cancer
- Being tested
- KVA12123 - Dose Escalation, KVA12123 Plus Pembrolizumab - Dose Escalation, KVA12123 - Dose Expansion, KVA12123 Plus Pembrolizumab - Dose Expansion
- Keywords
- TBS-2025, VISTA inhibiting antibody, TuHURA Biosciences, Inc.
- Medical subject headings
- Neoplasms, Melanoma, Carcinoma, Sarcoma, Lung Neoplasms, Prostatic Neoplasms, Breast Neoplasms, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KVA12123 - Dose EscalationDrug
Ascending KVA12123 doses given as monotherapy by intravenous administration every 2 weeks of each 6-week cycle.
KVA12123 Plus Pembrolizumab - Dose EscalationDrug
Also called Keytruda
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 ExpansionDrug
KVA12123 administered at the RP2D by intravenous administration every 2 weeks of each 6 week cycle.
KVA12123 Plus Pembrolizumab - Dose ExpansionDrug
Also called Keytruda
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: KVA12123 - Dose Escalation |
| 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. Receives: Drug: KVA12123 Plus Pembrolizumab - Dose Escalation |
| 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. Receives: Drug: KVA12123 - Dose Expansion |
| 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. Receives: Drug: KVA12123 Plus Pembrolizumab - Dose Expansion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Type and frequency of adverse events as assessed by CTCAE v5.0.
Measured: Through study completion, an average of 1 year
AEs related to study drug
Type and frequency of treatment related adverse events as assessed by CTCAE v4.0.
Measured: Through study completion, an average of 1 year
Recommended Phase 2 dose (RP2D) or maximum tolerated dose (MTD)
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).
Measured: Through study completion, an average of 1 year
Secondary outcomes (16)
Pharmacokinetic (PK) profile of KVA12123 (Cmax)
maximum serum concentration (micrograms/milliliter [mL])
Measured: Through study completion, an average of 1 year
Pharmacokinetic (PK) profile of KVA12123 (Cmin)
trough serum concentration (micrograms/mL)
Measured: Through study completion, an average of 1 year
Pharmacokinetic (PK) profile of KVA12123 (tmax)
time to maximum serum concentration (hours)
Measured: Through study completion, an average of 1 year
Pharmacokinetic (PK) profile of KVA12123 (AUC)
Area under the concentration-time curve (microgram*mL/hour)
Measured: Through study completion, an average of 1 year
Pharmacokinetic (PK) profile of KVA12123 (t1/2)
Elimination half life (hours)
Measured: Through study completion, an average of 1 year
Pharmacokinetic (PK) profile of KVA12123 (Vd)
Volume of distribution (milliliter or liter)
Measured: Through study completion, an average of 1 year
Pharmacokinetic (PK) profile of KVA12123 (Cl)
Clearance (mL/hour)
Measured: Through study completion, an average of 1 year
Concentration of anti-KVA12123 antibodies in serum
Change from baseline in anti-KVA12123 antibodies in serum (antibody concentration per mL)
Measured: Through study completion, an average of 1 year
Number of participants with progressive disease following treatment with KVA12123
Investigator assessment of radiographic imaging according to iRECIST.
Measured: Through study completion, an average of 1 year
Number of participants with progressive disease following treatment with KVA12123 in combination with pembrolizumab
Investigator assessment of radiographic imaging according to iRECIST.
Measured: Through study completion, an average of 1 year
Number of participants with stable disease following treatment with KVA12123
Investigator assessment of radiographic imaging according to iRECIST.
Measured: Through study completion, an average of 1 year
Number of participants with stable disease following treatment with KVA12123 plus pembrolizumab
Investigator assessment of radiographic imaging according to iRECIST.
Measured: Through study completion, an average of 1 year
Number of participants with partial response following treatment with KVA12123
Investigator assessment of radiographic imaging according to iRECIST.
Measured: Through study completion, an average of 1 year
Number of participants with partial response following treatment with KVA12123 plus pembrolizumab
Investigator assessment of radiographic imaging according to iRECIST.
Measured: Through study completion, an average of 1 year
Number of participants with complete response following treatment with KVA12123
Investigator assessment of radiographic imaging according to iRECIST.
Measured: Through study completion, an average of 1 year
Number of participants with complete response following treatment with KVA12123 plus pembrolizumab
Investigator assessment of radiographic imaging according to iRECIST.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2023
- Study start3 Mar 2023
- Primary completion16 Oct 2025
- Study completion18 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kineta Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Thierry Guillaudeux, PhD, Study director, Kineta Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05708950
- Sponsor's protocol ID
- VISTA-101
- Other IDs
- KEYNOTE-E67
- Status last verified
- Sep 2026
- First submitted
- 9 Dec 2022
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Open-label Trial of KVA12123 [TBS-2025] Alone and in Combination With Pembrolizumab in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05708950
- Acronym / sponsor ID
- VISTA-101
- Conditions
- Cancer, Solid Tumor, Melanoma, Carcinoma, Sarcoma, Lung Cancer
- Keywords
- TBS-2025, VISTA inhibiting antibody, TuHURA Biosciences, Inc.
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Kineta Inc.Industry (pharma, biotech, devices)
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 3 Mar 2023 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 18 Dec 2025 (actual)
- First posted
- 1 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial evaluated the safety and efficacy of KVA12123, subsequently designated TBS-2025, alone or combined with pembrolizumab in patients with advanced solid tumors. The study included dose escalation and planned dose expansion phases. Only the dose escalation phases were conducted. The planned dose expansion phase were not initiated following a business decision to discontinue development in solid tumors. This decision was unrelated to any identified safety concern.
The study sought to assess the safety of KVA12123 [TBS-2025] given alone or with pembrolizumab and to identify appropriate doses for future clinical trials. Participants in the doses for future clinical trials. Participants in the dose escalation phases visited study sites for treatment and safety assessments. These assessments included blood samples, imaging scans, physical examinations, and heart function tests.
Detailed description
This was a first-in-human (FIH), Phase 1/2, open-label, multicenter, dose escalation, and dose expansion study designed to evaluate the safety, tolerability, PK, immunogenicity, and tumor response of the investigational drug KVA12123, subsequently designated TBS-2025, alone and in combination with pembrolizumab in adults with relapsed or refractory advanced solid tumors. The study was planned to conduct in 4 planned parts: Parts A and B focus on dose escalation (single-agent and in combination), and Parts C and D focus on dose expansion (single-agent and in combination).
Parts A (single-agent KVA12123) and B (KVA12123 + pembrolizumab) allowed up to 10 dose escalation cohorts: 6 in Part A and 4 in Part B, with 1 to 6 participants per cohorts. These parts were intended to characterize safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary tumor response, and to inform the selection of recommended phase 2 doses.
Parts C (single-agent KVA12123) and D (KVA12123 + pembrolizumab) were planned but not initiated following a business decision to discontinue development in solid tumors. This decision was unrelated to any identified safety concern.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| KVA12123 [TBS-2025] Monotherapy Dose Escalation | Experimental | Drug: KVA12123 - Dose EscalationPart 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 | Drug: KVA12123 Plus Pembrolizumab - Dose EscalationPart B will consist of dose escalation with KVA12123 administered in combination with a fixed dose of pembrolizumab. |
| KVA12123 [TBS-2025] Monotherapy Dose Expansion | Experimental | Drug: KVA12123 - Dose ExpansionPart 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 | Drug: KVA12123 Plus Pembrolizumab - Dose ExpansionPart 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Willing and able to provide informed consent.
- Be at least 18 years of age at the time of consent.
- 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 no available curative therapy exists.
- Has expected survival ≥16 weeks.
- Presence of measurable disease by iRECIST.
Key exclusion criteria (31 listed)
- Untreated CNS metastatic disease, leptomeningeal disease, or cord compression.
- Concurrent cancer other than disease under study requiring systemic treatment. Participants with basal cell or squamous cell skin cancer treated with curative intent, carcinoma in-situ of the cervix or breast treated with curative intent, RAI stage 0 Chronic Lymphocytic Leukemia, monoclonal gammopathy of undetermined significance, superficial bladder cancer or very low and low risk prostate cancer (localized Gleason score ≤ 6) under active surveillance are eligible.
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg QD of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
- History of (non-infectious) pneumonitis/interstitial lung disease (ILD) that required steroids or current pneumonitis/ILD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KVA12123 - Dose EscalationAscending KVA12123 doses given as monotherapy by intravenous administration every 2 weeks of each 6-week cycle. | Drug | KVA12123 [TBS-2025] Monotherapy Dose Escalation |
| KVA12123 Plus Pembrolizumab - Dose EscalationAlso: KeytrudaAscending 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. | Drug | KVA12123 [TBS-2025] Plus Pembrolizumab Dose Escalation |
| KVA12123 - Dose ExpansionKVA12123 administered at the RP2D by intravenous administration every 2 weeks of each 6 week cycle. | Drug | KVA12123 [TBS-2025] Monotherapy Dose Expansion |
| KVA12123 Plus Pembrolizumab - Dose ExpansionAlso: KeytrudaKVA12123 administered at the RP2D by intravenous administration every 2 weeks in combination with a fixed dose of pembrolizumab administered once every 6 week cycle. | Drug | KVA12123 Plus Pembrolizumab Dose Expansion |
Primary outcome
Adverse Events
Time frame: Through study completion, an average of 1 year
Type and frequency of adverse events as assessed by CTCAE v5.0.
AEs related to study drug
Time frame: 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)
Time frame: 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).
16 secondary outcomes
Pharmacokinetic (PK) profile of KVA12123 (Cmax)
Time frame: Through study completion, an average of 1 year
Pharmacokinetic (PK) profile of KVA12123 (Cmin)
Time frame: Through study completion, an average of 1 year
Pharmacokinetic (PK) profile of KVA12123 (tmax)
Time frame: Through study completion, an average of 1 year
Pharmacokinetic (PK) profile of KVA12123 (AUC)
Time frame: Through study completion, an average of 1 year
Pharmacokinetic (PK) profile of KVA12123 (t1/2)
Time frame: Through study completion, an average of 1 year
Pharmacokinetic (PK) profile of KVA12123 (Vd)
Time frame: Through study completion, an average of 1 year
Pharmacokinetic (PK) profile of KVA12123 (Cl)
Time frame: Through study completion, an average of 1 year
Concentration of anti-KVA12123 antibodies in serum
Time frame: Through study completion, an average of 1 year
Number of participants with progressive disease following treatment with KVA12123
Time frame: Through study completion, an average of 1 year
Number of participants with progressive disease following treatment with KVA12123 in combination with pembrolizumab
Time frame: Through study completion, an average of 1 year
Number of participants with stable disease following treatment with KVA12123
Time frame: Through study completion, an average of 1 year
Number of participants with stable disease following treatment with KVA12123 plus pembrolizumab
Time frame: Through study completion, an average of 1 year
Number of participants with partial response following treatment with KVA12123
Time frame: Through study completion, an average of 1 year
Number of participants with partial response following treatment with KVA12123 plus pembrolizumab
Time frame: Through study completion, an average of 1 year
Number of participants with complete response following treatment with KVA12123
Time frame: Through study completion, an average of 1 year
Number of participants with complete response following treatment with KVA12123 plus pembrolizumab
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry Guillaudeux, PhD study director
Kineta Inc.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing KVA12123 - Dose Escalation, KVA12123 Plus Pembrolizumab - Dose Escalation and KVA12123 - Dose Expansion in people with Cancer and Solid Tumor, run by Kineta Inc. at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.