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PANCREATIC: METASTATIC: FIRST-LINE: Actuate 1801

Phase 1/2 Study of 9-ING-41, a Glycogen Synthase Kinase-3 Beta (GSK-3β) Inhibitor, as a Single Agent and Combined With Chemotherapy, in Patients With Refractory Hematologic Malignancies or Solid Tumors (pancreatic cohort)

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Pancreatic cancer

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

1st Line

Investigational Agent

9-ING-41

Drug Class

GSK-3beta inhibitor

PI

Brad Somer, MD

Sponsor

Actuate Therapeutics Inc.

Path

Pancreatic adenocarcinoma

Key Eligibility Criteria Details
  • Pathologically or cytologically confirmed metastatic pancreatic cancer
  • Previously untreated with systemic agents in recurrent/metastatic setting
  • Measurable disease
  • May have received adjuvant therapy if given at least 6 months before study enrollment
  • No significant cardiovascular impairment
  • No other malignancy
  •  
ADVANCED SOLID TUMORS: METASTATIC: TSC1/TSC2 alterations: last line: PRECISION 1

A Phase 2 Multi-center Open-label Basket Trial of Nab-sirolimus for Adult and Adolescent Patients With Malignant Solid Tumors Harboring Pathogenic Inactivating Alterations in TSC1 or TSC2 Genes.

VIEW TRIAL ON CLINICALTRIALS.GOV
Malignancy

Breast, lung, colon, prostate, bladder, RCC, kidney, skin, melanoma, gastric, pancreatic, HCC, rectal, sarcoma, head and neck, esophagus, biliary tract

Stage

Stage 4

Phase

Phase 2

Status

Open to Enrollment

Line Of Therapy

Last line

Investigational Agent

nab-sirolimus

Drug Class

MTOR inhibitor

PI

Dan Vaena, MD

Sponsor

Aadi Bioscience, Inc.

Path

TSC1 or TSC2 alterations

Key Eligibility Criteria Details
  • Malignant solid tumor with pathogenic inactivating TSC1 or TSC2 alterations. GEnetic alterations should be identified using NGS in tumor tissue or liquid biopsy
  • Metastatic or locally advanced solid tumors
  • Must have received all standard therapies appropriate for their tumor type and stage of disease or, in the opinion of the investigator, the patient would b e unlikely to tolerate or derive clinically meaningful benefit from appropriate SOC therapy
  • Measurable disease
  • ECOG PS 0-1
  • Fasting tryglecerid must be < or = 300; fast serus cholesterol must be < or = to 350
  • No prior treatment with MTOR inhibitor
  • No primary brain tumors
  • No known HIV
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