Description:
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and
preliminary efficacy of KIN-2787 in adults with BRAF-mutated advanced or metastatic solid
tumors.
Title
- Brief Title: A Study to Evaluate KIN-2787 in Subjects With BRAF Mutation Positive Solid Tumors
- Official Title: A Phase 1/1b Open-Label, Multicenter, Two Part Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of KIN-2787 in Subjects With BRAF Mutation Positive Solid Tumors
Clinical Trial IDs
- ORG STUDY ID:
KN-8701
- NCT ID:
NCT04913285
Conditions
- Solid Tumor, Adult
- Non-small Cell Lung Cancer
- Melanoma
Interventions
Drug | Synonyms | Arms |
---|
KIN-2787 | | Dose Escalation |
Purpose
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and
preliminary efficacy of KIN-2787 in adults with BRAF-mutated advanced or metastatic solid
tumors.
Detailed Description
BRAF, a gene that helps to control cell growth, is commonly altered in some cancers. BRAF
alterations can be categorized into three classes based on their unique properties. Targeted
therapies have been approved to treat certain types of cancers that harbor BRAF Class I
mutations. However, there are currently no approved BRAF targeted therapies available for
patients with tumors driven by Class II or Class III BRAF alterations
This study will evaluate the safety, pharmacokinetics (PK), and early clinical activity of
KIN-2787, an experimental drug intended to target solid tumors harboring Class I, Class II,
or Class III BRAF alterations.
Trial Arms
Name | Type | Description | Interventions |
---|
Dose Escalation | Experimental | Dose escalation of KIN-2787 in patients with solid tumors harboring Class I, Class II, or Class III BRAF alterations | |
Dose Expansion | Experimental | Dose expansion evaluating the recommended phase 2 dose (RP2D) of KIN-2787 in patients with NSCLC, melanoma, and other solid tumors harboring Class II or Class III BRAF alterations | |
Eligibility Criteria
Inclusion Criteria:
- Provide written informed consent prior to initiation of any study-specific procedures.
- Metastatic or advanced stage solid tumor.
- Known BRAF Class I, Class II, or Class III alteration as confirmed by previous genomic
analysis of tumor tissue or ctDNA.
- Must have received prior standard therapy appropriate for the tumor type and stage of
disease (including prior therapy with a BRAF inhibitor if FDA approved for the cancer
type), OR unlikely to tolerate or derive clinically meaningful benefit from
appropriate standard of care therapy.
- Measurable or evaluable disease by RECIST v1.1.
- ECOG performance status 0, 1, or 2.
- Adequate organ function, as measured by laboratory values (criteria listed in
protocol).
- Able to swallow, retain, and absorb oral medications.
Exclusion Criteria:
- Known active brain metastases from non-brain tumors.
- For tumor types and indications not approved by FDA, prior receipt of any BRAF-, MEK-,
or MAPK-directed inhibitor therapy.
- GI tract disease causing an inability to take oral medication, malabsorption syndrome,
requirement for intravenous alimentation, or uncontrolled inflammatory GI disease.
- Seropositive for hepatitis B or hepatitis C.
- Women who are lactating or breastfeeding, or pregnant.
- In Dose Expansion, patients with BRAF Class I mutations are excluded.
Complete inclusion and exclusion criteria are listed in the clinical study protocol.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | 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. |
Time Frame: | Initiation of study drug through 28 days after last dose (up to approximately 18 months) |
Safety Issue: | |
Description: | Measure of clinical benefit, defined as the time from initial tumor response to documented tumor progression |
Secondary Outcome Measures
Measure: | Maximum observed plasma concentration (Cmax) of KIN-2787 |
Time Frame: | Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months) |
Safety Issue: | |
Description: | |
Measure: | Time to achieve Cmax (Tmax) |
Time Frame: | Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months) |
Safety Issue: | |
Description: | |
Measure: | Area under the plasma concentration-time curve (AUC). |
Time Frame: | Initiation of study drug through Cycle 5, where each cycle is 28 days (up to approximately 4 months) |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Kinnate Biopharma |
Trial Keywords
- BRAF inhibitor
- BRAF
- pan-RAF
- pan-RAF inhibitor
- RAF1
- ARAF
- BRAF alteration
- BRAF Class II
- BRAF Class III
- V600
- tumor growth inhibitor (TGI)
- melanoma
- NSCLC
- solid tumor
- targeted therapy
- BRAF Class I
Last Updated
August 18, 2021