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RecruitingPhase 1

A Phase 1 Dose Escalation and Dose Expansion Trial of KST-6051 in Participants With Advanced Solid Tumors With Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Mutation

A First-in-human Phase 1 Dose Escalation and Dose Expansion Study Evaluating the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of KST-6051 in Patients With Advanced or Metastatic Solid Tumors With a KRAS Mutation

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether KST-6051 is safe and how well adults can tolerate it. The drug is taken by mouth, alone or with other cancer drugs. It is for adults with advanced solid tumors that have certain changes in a gene called KRAS.

The main purpose of the trial is to assess whether the trial drug, KST-6051, is safe and tolerable when administered orally, alone or in combination with other anticancer agents, to adults with advanced or metastatic solid tumors with certain KRAS mutations.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18 or older.
  • You are willing and able to sign a form agreeing to join the study.
  • A tissue test shows lung, pancreatic, colorectal, or another solid cancer that has spread nearby and cannot be removed by surgery, or has spread to distant parts of the body.
  • A test confirms a KRAS gene change before your first dose of the study drug.
  • You can do all normal daily activities, or can do light work but have trouble with hard physical activity.
  • Your heart, blood, liver, and kidneys work well enough for the study.
  • Your cancer can be measured using the study's rules before treatment starts.

Who can't join

  • You have a brain or spinal cord tumor, or cancer that has spread there and is untreated or not stable.
  • You cannot swallow medicines.
  • You are pregnant, breastfeeding, or expect to become pregnant or father a child during the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Age ≥ 18 years. 2. Willing and able to give written informed consent. 3. Histologically documented locally advanced and unresectable or metastatic NSCLC, PDAC, CRC, or other solid tumor. 4. Documentation of KRAS mutation prior to the first dose of trial drug(s). 5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. 6. Adequate cardiovascular, hematological, liver, and renal function. 7. Measurable disease at baseline per Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST 1.1). Exclusion Criteria: 1. Central nervous system (CNS) tumors or untreated or unstable metastases. 2. Inability to swallow oral medications. 3. Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial. Other inclusion/exclusion criteria are specified in the protocol.

Study sites (9)

CA

FL

MA

  • Mass General Brigham Cancer Institute at Massachusetts General Hospital · Boston, MA 02114More trials in Boston

PA

TX

UT

VA