[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Email address

clinicaltrials@kinnate.com

Condition

Melanoma,Non-small Cell Lung Cancer,Solid Tumor, Adult

Treatment type

Interventional

Investigational product

KIN-2787

Phase

Phase 1

Sponsor

Kinnate Biopharma

ClinicalTrials.gov identifier

NCT04913285

Study number

KN-8701

Understanding clinical trials

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About the study

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of KIN-2787 in adults with BRAF/NRAS-mutated advanced or metastatic solid tumors.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

  1. Provide written informed consent prior to initiation of any study-specific procedures.
  2. Metastatic or advanced stage solid tumor
  3. Known BRAF Class I, Class II, or Class III alteration or melanoma with an NRAS mutation as confirmed by previous genomic analysis of tumor tissue or ctDNA.
  4. Measurable (Part A and B) or evaluable (Part A only) disease by RECIST v1.1.
  5. ECOG performance status 0-1
  6. Adequate organ function, as measured by laboratory values (criteria listed in protocol).
  7. Able to swallow, retain, and absorb oral medications.
Exclusion criteria

  1. Known participants who have received local therapy with either surgery and/or radiation therapy (participants with asymptomatic untreated brain metastasis may be eligible if met with certain criteria)
  2. In Part B Dose Expansion, previous treatment with any approved or in-development small molecule BRAF-, MEK-, or MAPK-directed inhibitor therapy.
  3. GI tract disease causing an inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, or uncontrolled inflammatory GI disease.
  4. Active, uncontrolled bacterial, fungal, or viral infection.
  5. Participant with a positive test result for SARS-CoV2 infection, is known to have asymptomatic infection or is suspected of having SARS-CoV2, is excluded
  6. Women who are lactating or breastfeeding, or pregnant.
  7. In Part B Dose Expansion, patients with BRAF Class I mutations are excluded.
  8. Participants with any other active treated malignancy within 3 years prior to enrollment Complete inclusion and exclusion criteria are listed in the clinical study protocol.

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

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