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KVA12123 Plus Pembrolizumab Dose Expansion for Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Sarah Cannon Research Institute at Tennessee Oncology, Nashville, TNCancer+16 MoreKVA12123 Plus Pembrolizumab - Dose Escalation - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a new drug to see if it's safe and effective in treating advanced solid tumors. Participants will visit the site regularly and receive treatments, with tests to check safety and cancer progression.

Eligible Conditions
  • Stomach Cancer
  • Ovarian Cancer
  • Cancer
  • Prostate Cancer
  • Breast Cancer
  • Uterine Cancer
  • Head and Neck Cancer
  • Colorectal Cancer
  • Pancreatic Cancer
  • Kidney Cancer
  • Solid Tumors
  • Melanoma
  • Esophageal Cancer
  • Sarcoma
  • Lung Cancer
  • Thyroid Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

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KIN-2787
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Phase Ib: Dose Escalation

Study Objectives

3 Primary · 16 Secondary · Reporting Duration: Through study completion, an average of 1 year

Year 1
AEs related to study drug
Adverse Events
Concentration of anti-KVA12123 antibodies in serum
Number of participants with complete response following treatment with KVA12123
Number of participants with complete response following treatment with KVA12123 plus pembrolizumab
Number of participants with partial response following treatment with KVA12123
Number of participants with partial response following treatment with KVA12123 plus pembrolizumab
Number of participants with progressive disease following treatment with KVA12123
Number of participants with progressive disease following treatment with KVA12123 in combination with pembrolizumab
Number of participants with stable disease following treatment with KVA12123
Number of participants with stable disease following treatment with KVA12123 plus pembrolizumab
Pharmacokinetic (PK) profile of KVA12123 (AUC)
Pharmacokinetic (PK) profile of KVA12123 (Cl)
Pharmacokinetic (PK) profile of KVA12123 (Cmax)
Pharmacokinetic (PK) profile of KVA12123 (Cmin)
Pharmacokinetic (PK) profile of KVA12123 (Vd)
Pharmacokinetic (PK) profile of KVA12123 (t1/2)
Pharmacokinetic (PK) profile of KVA12123 (tmax)
Recommended Phase 2 dose (RP2D) or maximum tolerated dose (MTD)

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
AND019 PO QD
1
KIN-2787
1
Phase Ib: Dose Escalation

Trial Design

4 Treatment Groups

KVA12123 Plus Pembrolizumab Dose Expansion
1 of 4
KVA12123 Monotherapy Dose Escalation
1 of 4
KVA12123 Plus Pembrolizumab Dose Escalation
1 of 4
KVA12123 Monotherapy Dose Expansion
1 of 4

Experimental Treatment

314 Total Participants · 4 Treatment Groups

Primary Treatment: KVA12123 Plus Pembrolizumab Dose Expansion · No Placebo Group · Phase 1 & 2

KVA12123 Plus Pembrolizumab Dose Expansion
Drug
Experimental Group · 1 Intervention: KVA12123 Plus Pembrolizumab - Dose Expansion · Intervention Types: Drug
KVA12123 Monotherapy Dose Escalation
Drug
Experimental Group · 1 Intervention: KVA12123 - Dose Escalation · Intervention Types: Drug
KVA12123 Plus Pembrolizumab Dose Escalation
Drug
Experimental Group · 1 Intervention: KVA12123 Plus Pembrolizumab - Dose Escalation · Intervention Types: Drug
KVA12123 Monotherapy Dose Expansion
Drug
Experimental Group · 1 Intervention: KVA12123 - Dose Expansion · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year

Who is running the clinical trial?

Kineta Inc.Lead Sponsor
3 Previous Clinical Trials
80 Total Patients Enrolled
Merck Sharp & Dohme LLCIndustry Sponsor
3,706 Previous Clinical Trials
4,963,743 Total Patients Enrolled
Thierry Guillaudeux, PhDStudy DirectorKineta Inc.

Eligibility Criteria

Age 18+ · All Participants · 17 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least 16 weeks.
References

Frequently Asked Questions

Are there still opportunities to partake in this study?

"Affirmative, the study is currently seeking enrollees. The trial was initially posted on March 3rd 2023 and has since been updated on the same date. It requires 314 individuals to be recruited from 2 different medical facilities." - Anonymous Online Contributor

Unverified Answer

What is the aggregate amount of participants involved in this experiment?

"Affirmative. The clinical trial's webpage on clinicaltrials.gov attests to its active recruitment of participants, which began on March 3rd 2023 and was last updated the same day. It is currently looking for 314 individuals from 2 separate sites." - Anonymous Online Contributor

Unverified Answer

What is the fundamental purpose of this trial?

"This clinical experiment will be assessing the RP2D or MTD of a drug over one year as its primary outcome. Additionally, secondary goals are to measure partial response in patients, peak serum concentration time (tmax), and change from baseline anti-KVA12123 antibodies in serum concentrations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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