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A Phase I Study of KSQ-4279 Alone and in Combination in Patients with Advanced Solid Tumors

Krishnansu Tewari


A Study On:

  • Stomach
  • Ovary
  • Thyroid
  • Unknown Sites
  • Breast
  • Bones and Joints
  • Other Male Genital
  • Kidney
  • Esophagus
  • Other Skin
  • Cervix
  • Corpus Uteri
  • Urinary Bladder
  • Other Endocrine System
  • Multiple Myeloma
  • Melanoma, Skin
  • Rectum
  • Pancreas
  • Lung
  • Soft Tissue
  • Lip, Oral Cavity and Pharynx
  • Small Intestine
  • Anus
  • Liver
  • Other Digestive Organ
  • Larynx
  • Other Respiratory and Intrathoracic Organs
  • Prostate
  • Brain and Nervous System
  • Colon
  • Other Urinary
  • Eye and Orbit

Status:

Eligibility

Adults

Interested in joining this trial?

Official Title

A Phase I Study of KSQ-4279 Alone and in Combination in Patients with Advanced Solid Tumors

Details

This is a Phase 1 study to assess the safety and clinical activity of KSQ-4279 alone and in combination in patients with advanced solid tumors. This is a Phase 1 study consisting of 2 parts: Dose Escalation and Expansion to evaluate the safety, tolerability, clinical activity, and pharmacokinetics (PK) Study of KSQ-4279 as a Monotherapy or in Combination in Patients with Advanced Solid Tumors.


Eligibility

You can join if...

Inclusion Criteria:
-Adequate bone marrow and organ function at baseline
-Life expectancy of >12 weeks
-Histologically or cytologically confirmed locally advanced (unresectable) or metastatic solid tumors who meet one of the following criteria (dose escalation only):
a. Relapsed or progressed through standard therapy
b. Have a disease for which no standard effective therapy exists
c.Not a candidate for standard effective therapy

Exclusion Criteria:
-Grade 2 or greater toxicity, except alopecia related to any prior treatment (ie, chemotherapy, targeted therapy, radiation, or surgery)
-Prior anticancer treatment including:

a. Chemotherapy or small molecule-targeted therapy < 2 weeks prior to first dose of study treatment
b. Any antibody therapy < 5 half-lives from first dose of study treatment (or 4 weeks since last therapy, whichever is the shortest)
c. PD-1 (anti-programmed death 1) or PD-L1 (anti-programmed death ligand 1) therapy < 4 weeks from first dose of study treatment
d. Invasive surgery requiring general anesthesia < 30 days from first dose of study treatment
e. Chemotherapy with nitrosoureas or mitomycin C, < 45 days from first dose of study treatment
f. Radiation therapy (including radiofrequency ablation) < 4 weeks prior to initiation of study treatment

Get in touch with our study team