Trial NCT07458347
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
- Phase
- Phase 1
- Sponsor
- Kestrel Therapeutics, Inc.
- Conditions
- KRAS-mutant Non-small Cell Lung Cancer (NSCLC); KRAS-mutant Pancreatic Ductal Adenocarcinoma (PDAC); KRAS-mutant Colorectal Cancer (CRC); Other KRAS-mutant Solid Tumors
- Ages
- 18+ years
Eligibility criteria
Highlighted: restrictions our model extracted, each a verbatim quote (pink = excludes outright, blue = only under conditions).
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.Performance status
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.Brain metastases
2. Inability to swallow oral medications.
3. Pregnant, breastfeeding, or expecting to conceive or father children within the projected duration of the trial.Pregnancy
Other inclusion/exclusion criteria are specified in the protocol.
Restrictions found (3)
- Brain metastasesConditionalexclusionShow in the text
- Performance statusOutrightinclusion
ECOG PS 0 or 1
Show in the text - PregnancyOutrightexclusionShow in the text
Recruiting in Massachusetts
- Mass General Brigham Cancer Institute at Massachusetts General Hospital · Boston, Suffolk County