Verified

KIN-2787 for Melanoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Melanoma+2 MoreKIN-2787 - Drug
Eligibility
18+
All Sexes
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Study Summary

This trial is testing a new drug, KIN-2787, for safety and effectiveness in adults with solid tumors that have BRAF or NRAS mutations.

Eligible Conditions
  • Melanoma
  • Solid Tumors, Adult
  • Non-small Cell Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

Study Objectives

11 Primary · 12 Secondary · Reporting Duration: Initiation of study drug until disease progression (up to approximately 36 months)

Month 18
Incidence of dose limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), treatment-related adverse events (TRAEs), and incidence of clinically significant changes in vital signs, physical examinations, ECGs, and clinical laboratory tests.
Part A1 Dose escalation monotherapy
Part A2 Dose Escalation: KIN-2787 + Binimetinib Combination
Month 4
Area under the plasma concentration-time curve (AUC).
Plasma
Part A1 Dose Escalation: Characterization of PK properties and effect of food on PK of KIN-2787 including, but not limited to AUC.
Part A1 Dose Escalation: Characterization of PK properties and effect of food on PK of KIN-2787 including, but not limited to Cmax.
Part A1 Dose Escalation: Characterization of PK properties and effect of food on PK of KIN-2787 including, but not limited to tmax.
Part A2 Dose Escalation: characterization of PK properties of KIN-2787 and binimetinib in combination including, but not limited to AUC.
Part A2 Dose Escalation: characterization of PK properties of KIN-2787 and binimetinib in combination including, but not limited to Cmax.
Part A2 Dose Escalation: characterization of PK properties of KIN-2787 and binimetinib in combination including, but not limited to tmax.
Part B Dose Expansion: characterization of PK properties of KIN-2787 including, but not limited to AUC.
Part B Dose Expansion: characterization of PK properties of KIN-2787 including, but not limited to Cmax.
Part B Dose Expansion: characterization of PK properties of KIN-2787 including, but not limited to tmax.
Time to achieve Cmax (Tmax)
Month 36
In Part B (Dose Expansion) - disease control rate (DCR).
In Part B (Dose Expansion) - duration of overall response (DOR).
In Part B (Dose Expansion) - duration of stable disease.
In Part B (Dose Expansion) - objective response rate (ORR) using RECIST v1.1.
In Part B (dose expansion) - disease control rate (DCR).
In Part B (dose expansion) - duration of overall response (DOR).
In Part B (dose expansion) - duration of stable disease.
In Part B (dose expansion) - objective response rate (ORR) using RECIST v1.1.

Trial Safety

Safety Progress

1 of 3

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Trial Design

5 Treatment Groups

Dose Escalation
1 of 5
Dose Expansion
1 of 5
Dose Expansion (Part B)
1 of 5
Dose Escalation Combination therapy (Part A2)
1 of 5
Dose Escalation Monotherapy (Part A1)
1 of 5

Experimental Treatment

155 Total Participants · 5 Treatment Groups

Primary Treatment: KIN-2787 · No Placebo Group · Phase 1

Dose Escalation
Drug
Experimental Group · 1 Intervention: KIN-2787 · Intervention Types: Drug
Dose Expansion
Drug
Experimental Group · 1 Intervention: KIN-2787 · Intervention Types: Drug
Dose Expansion (Part B)
Drug
Experimental Group · 1 Intervention: KIN-2787 · Intervention Types: Drug
Dose Escalation Combination therapy (Part A2)
Drug
Experimental Group · 1 Intervention: KIN-2787 and binimetinib · Intervention Types: Drug
Dose Escalation Monotherapy (Part A1)
Drug
Experimental Group · 1 Intervention: KIN-2787 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: initiation of study drug until disease progression (up to approximately 36 months)

Who is running the clinical trial?

Kinnate BiopharmaLead Sponsor
1 Previous Clinical Trials
120 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

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Who else is applying?

What state do they live in?
California60.0%
Florida40.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria80.0%
Met criteria20.0%
What site did they apply to?
Stanford Cancer Center50.0%
Providence Medical Foundation (St. Joseph's)50.0%
How many prior treatments have patients received?
0100.0%